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Association details:
Biomarker:EGFR mutation
Cancer:Non Small Cell Lung Cancer
Drug:erlotinib (EGFR inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: A1 - Approval
New
Excerpt:
Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations and stable disease after first-line chemotherapy.
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Title:

Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

Excerpt:
First-line treatment of EGFR-mutated NSCLC: Erlotinib/bevacizumab represents a front-line treatment option in patients with EGFR-mutated tumours.
DOI:
10.1093/annonc/mdy275
Evidence Level:
Sensitive: B - Late Trials
Title:

359P - The role of adjuvant targeted therapy for postoperative EGFR mutant non-small cell lung cancer: A network meta-analysis

Published date:
11/17/2020
Excerpt:
Osimertinib showed the most favorable DFS, with significant superiority versus erlotinib (HR 0.4, 95% CI 0.24-0.66), gefitinib (0.42, 0.26-0.67), chemotherapy (0.23, 0.15-0.33) and placebo (0.17, 0.12- 0.24), but with no significant improvement versus CT +TKI (0.86, 0.42-1.74)....EGFR-TKIs monotherapy provided more survival improvement for patients with exon 19 deletion than with L858R mutation (HR, 0.31 [0.13, 0.75] for exon 19 deletion, and 0.48 [0.35, 0.65] for L858R mutation, respectively).
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Real world data of efficacy and safety of erlotinib as first-line TKI treatment in EGFR mutation-positive advanced non-small cell lung cancer: Results from the EGFR-2013-CPHG study

Published date:
11/01/2020
Excerpt:
A total of 177 patients, aged 72 years on average, were enrolled over a 2-year period....Median PFS was 11.7 months and OS 25.8 months, with respectively a 1-year rate of 48.6% and 74%....This study has confirmed erlotinib's efficacy and safety for unselected patients...
DOI:
10.1016/j.resmer.2020.100795
Evidence Level:
Sensitive: B - Late Trials
New
Title:

Prospective Molecular Marker Analyses of EGFR and KRAS From a Randomized, Placebo-Controlled Study of Erlotinib Maintenance Therapy in Advanced Non–Small-Cell Lung Cancer

Excerpt:
The phase III, randomized, placebo-controlled Sequential Tarceva in Unresectable NSCLC (SATURN; BO18192) study found that erlotinib maintenance therapy extended progression-free survival (PFS)...A profound predictive effect on PFS of erlotinib relative to placebo was observed in the EGFR mutation–positive subgroup (hazard ratio [HR], 0.10; P<0.001).
DOI:
10.1200/JCO.2010.31.8162
Evidence Level:
Sensitive: B - Late Trials
New
Title:

Phosphoinositide-3-Kinase Catalytic Alpha and KRAS Mutations are Important Predictors of Resistance to Therapy with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors in Patients with Advanced Non-small Cell Lung Cancer

Excerpt:
...we have investigated PIK3CA, EGFR, and KRAS gene mutations in patients with advanced NSCLC who had been treated with gefitinib or erlotinib...Median TTP was significantly shorter in the patients with mutated PIK3CA and KRAS (log-rank test, p = 0.01, and p = 0.003...Longer median TTP was observed in patients with mutated EGFR (log-rank test, p< 0.0001…In a multivariate logistic regression analysis for response to EGFR-TKIs, performance status 0 and EGFR mutation were confirmed to be independent predictive favorable factors of response to TKIs treatment (p = 0.01 and p< 0.0001...
DOI:
https://doi.org/10.1097/JTO.0b013e31820a3a6b
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Phase 2 Study of Maintenance OSI-906 Plus Erlotinib (Tarceva®), or Placebo Plus Erlotinib in Patients With Nonprogression Following 4 Cycles of Platinum-based Chemotherapy

Excerpt:
...- EGFR mutation status must be confirmed for participation in the study....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Pacritinib in Patients With Endothelial Growth Factor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC) After EGFR Tyrosine Kinase Inhibitor (TKI)

Excerpt:
...- Histologically or cytologically confirmed metastatic or unresectable locally advanced NSCLC with known sensitive EGFR mutations....
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Erlotinib Therapy and Subsequent Development of Mechanisms of Secondary Resistance in Patients With NSCLC

Excerpt:
...- Documentation of a sensitizing mutation of the epidermal growth factor receptor....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (TRIGGER)

Excerpt:
...Percentage of Participants Who Died`Overall Survival (OS)`Percentage of Participants With a Response by Best Overall Response`Percentage of Participants With Objective Response`Percentage of Participants Achieving CR, PR, or SD as Best Overall Response`Percentage of Participants With Primary and Secondary Resistance`Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation by Mutation Type...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Erlotinib and Chemotherapy for Patients With Stage IB-IIIA NSCLC With EGFR Mutations (ECON)

Excerpt:
...- Patients must have lung cancer with a documented EGFR activating mutation (exon 19 deletion, L858R, L861Q)...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

ASPET Study: An Observational Study of Tarceva (Erlotinib) in First Line in Patients With Advanced Non-Small Cell Lung Cancer Harbouring EGFR Activating Mutations

Excerpt:
...- EGFR mutation-positive disease according to local laboratory testing...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A study for the improved effect of Chinese Herb Basil on EGFR-TKI and platinum in Non-small Cell Lung Cancer Patients by Temperature-Controlled NanoVelcro CTC purification systems

Excerpt:
...abundance of EGFR mutation - abundance of EGFR mutation; BRCA1 and ERCC1 mRNA level - BRCA1 and ERCC1 mRNA level; blood biochemical indexes - blood biochemical indexes; Response Rate - Response Rate...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Study of Erlotinib (Tarceva®) in Combination With OSI-906 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene

Excerpt:
...- Exon 19 deletion or exon 21 activating mutation in EGFR...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Trial of Ruxolitinib and Erlotinib in Patients With EGFR-mutant Lung Adenocarcinoma With Acquired Resistance to Erlotinib

Excerpt:
...- a documented somatic activating mutation in EGFR (including but...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Study of Tarceva and Targretin in Stage I-II Lung Cancer

Excerpt:
...Tumor Tissue Concentrations of Erlotinib and Bexarotene and Correlation With Plasma Levels`Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Study of Tarceva and Targretin Oral Capsules in Patients With Advanced Lung Cancer

Excerpt:
...Progression-free Survival and Overall Survival`Evaluation of EGFR Mutations in Tumor Biopsies and Correlation of EGFR Mutations With Objective Radiographic Responses....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Erlotinib Hydrochloride in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Completely Removed by Surgery (An ALCHEMIST Treatment Trial)

Excerpt:
...- Previously registered to A151216, with the result of lung cancer harboring an EGFR exon 19 deletion or L858R mutation; the testing must have been performed by one of the following criteria: 1....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study of LY2875358 in Participants With Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations

Excerpt:
...- Have molecular evidence of an epidermal growth factor receptor mutation (EGFRmt) known to be associated with EGFR tyrosine kinase inhibitor (TKI) drug sensitivity (G719X, exon 19 deletion, L858R, L861Q)...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

To Evaluate OBI-833/OBI-821 in Combination With First-Line Erlotinib in Patients With EGFR-Mutated, Globo H-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Excerpt:
...The tumor harbors an exon 19 deletion or exon 21 L858R mutation in EGFR, confirmed locally....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR

Excerpt:
...harbouring deletions in the exon 19 or mutation in the exon 21 in the TK of the EGFR....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

INC280 and Erlotinib Hydrochloride in Treating Patients With Non-small Cell Lung Cancer

Excerpt:
...- A tumor that harbors an EGFR mutation known to be associated with drug sensitivity (i.e. G719X, exon 19 deletion, L858R, L861Q)...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Prospective Observational Study Evaluating c-MET Expression and EGFR Gene Mutation Correlation With Erlotinib Response

Excerpt:
...To investigate C-met expression/amplification and EGFR gene mutations in NSCLC patients treated with Erlotinib : C-met expression by IHC C-met amplification by SISH EGFR mutation by real time PCR`The rates of C-met expression/amplification and EGFR gene mutations...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Phase 2, Study of Ficlatuzumab Plus Erlotinib vs. Placebo Plus Erlotinib in Subjects With Previously Untreated Metastatic, EGFR-mutated NSCLC and BDX004 Positive Label

Excerpt:
...To evaluate Safety and tolerability of ficlatuzumab plus erlotinib versus placebo plus erlotinib in subjects who have previously untreated metastatic EGFR-mutated NSCLC and a BDX004 Positive Label....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Excerpt:
...- Diagnosis of locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the EGFR...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Trial of Erlotinib and BKM120 in Patients With Advanced Non Small Cell Lung Cancer Previously Sensitive to Erlotinib

Excerpt:
...- Patients treated with erlotinib (or gefitinib or other EGFR TKI) for any duration in the presence of a known EGFR activating mutation that confers sensitivity to TKI treatment....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Rapid Plasma Genotyping For Early Initiation Of Erlotinib In EGFR Mutant Lung Cancer

Excerpt:
...--Participants with positive or pending EGFR mutation on plasma genotyping performed at the central lab are eligible for enrollment, and will...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study of Emibetuzumab in Non Small Cell Lung Cancer (NSCLC) Participants

Excerpt:
...- Objective clinical benefit from erlotinib treatment as defined by either documented partial or complete response or stable disease ≥6 months or, if most recent erlotinib treatment has been initiated based on documented epidermal growth factor receptor mutation (EGFRmt) status, at least 12 weeks stable disease...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A prospective, open-labelled, randomized, multicenter phase II study to evaluate efficacy and safety of Erlotinib vs NP chemotherapy as adjuvant therapy in post radical operation IIIA NSCLC patients with EGFR 19 or 21 exon mutation

Excerpt:
...Inclusion Criteria of Target Disease: IIIA NSCLC patients according to TMN-staging of Lung Staging Standard version 7 2009, confirmed by histopathology or cytology after radical operation, and having EGFR exon 19 deletion mutation or exon 21 L858R single base substitution; Accept study adjuvant therapy within 4 weeks post radical operation; ECOP PS 0-1; Life expectancy >=12 weeks. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Genomic Landscape of EGFR Mutant NSCLC Prior to Erlotinib and at the Time of Disease Progression

Excerpt:
...- Presence of known sensitizing mutations in EGFR TK domain...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Multicenter Randomized Phase III Study Comparing Second-line Treatment With Chemotherapy Associated or Not to Erlotinib in NSCLC Patients With Secondary Resistance to TKI-EGFR

Excerpt:
...- Presence of one of the EGFR activating mutations in the tumor (exon 19 deletion or L858R, G719X or L861Q)...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study of the Efficacy and Safety of MetMAb Combined With Tarceva in Patients With Met-Positive Non-Small Cell Lung Cancer

Excerpt:
...- Met-positive status and results of epidermal growth factor receptor (EGFR)-activating mutation testing....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Targeted Treatment With Intercalated Radiotherapy in EGFR-mutant IIIA/IIIB NSCLC

Excerpt:
...EGFR activating mutations in exon 18, 19 or 21were detected in tumor tissue or plasma....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Chemotherapy and Erlotinib for Lung Cancer With Low Abundance Epidermal Growth Factor Receptor Mutation

Excerpt:
...EGFR mutation:...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Adjuvant Erlotinib Intercalating Chemotherapy or Adjuvant Chemotherapy Alone in NSCLC With Common EGFR Mutation

Excerpt:
...- Confirmed with Exon 19 deletion or L858R EGFR mutation...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib

Excerpt:
...Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) non-squamous NSCLC with wild-type (excluding major activating mutation (exon 19 deletion and/or exon 21 L858R mutation)) EGFR gene status confirmed by a highly sensitive PCR assay 3....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study of Onartuzumab (MetMAb) in Combination With Tarceva (Erlotinib) in Participants With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Chemotherapy For Advanced or Metastatic Disease (MetLung)

Excerpt:
...- Results of endothelial growth factor receptor (EGFR)-activating mutation testing...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

An Observational Study of Tarceva (Erlotinib) in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer With Wild-Type Epidermal Growth Factor Receptor (EGFR) Gene (WILT)

Excerpt:
...EGFR mutation status are allowed if they fulfil the following criteria:...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

An Observational Study of Tarceva (Erlotinib) in First Line in Patients With Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer (GERTAC)

Excerpt:
...- Locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Erlotinib Hydrochloride and Quinacrine Dihydrochloride in Stage IIIB-IV Non-Small Cell Lung Cancer

Excerpt:
...- Patients must have received at least one platinum-containing regimen for the treatment of advanced or metastatic disease (except for EGFR-mutant patients)....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Go to data
Title:

Erlotinib in Post Radical Operation NSCLC Patients With EGFR Mutation

Excerpt:
...- IIIA NSCLC patients according to TMN-staging of Lung Staging Standard version 7 2009, confirmed by histopathology or cytology after radical operation, and having EGFR exon 19 deletion mutation or exon 21 L858R single base substitution;...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study of Erlotinib (Tarceva) in Participants With Non-Small Cell Lung Cancer (NSCLC)

Excerpt:
...Number of participants with EGFR mutation (L858R/ exon 19 deletion) and who achieved clinical benefit status was reported. ...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Phase I Imaging Study Evaluating Dalotuzumab (MK0646) in Combination With Erlotinib for Patients With Non-Small Cell Lung Cancer (MK-0646-008)

Excerpt:
...have documented EGFR mutation or EGFR gene amplification, regardless of demographic or clinical characteristics, who have had...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study to Assess the Incidence of EGFR Mutation in Patients With Newly Diagnosed Locally Advanced or Metastatic Non-Small Cell Lung Cancer in the UK, And of Tarceva (Erlotinib) as First-Line Therapy in EGFR Mutation Positive Patients.

Excerpt:
...histologically confirmed EGFR exon 19 deletion or exon 21 mutation in the diagnostic phase of the study...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Non Small Cell Lung Cancer Patients Treated With Erlotinib Six Months or Longer

Excerpt:
...- Patients must have tissue available for EGFR-mutation status testing (if...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Safety and Effectiveness Study of Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With NSCLC

Excerpt:
...Histology and cytology confirmed with unfavorable surgical locally advanced stage (stage IIIB) or metastatic NSCLC (IV), Sensitive EGFR gene mutation 5....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study of Tarceva (Erlotinib) in First Line in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With EGFR Mutations

Excerpt:
...- Non-small cell lung cancer with an EGFR activating mutation...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Randomized, Double-Blind Trial of Erlotinib/Pazopanib or Erlotinib/Placebo in Patients With Previously Treated Advanced Non-Small-Cell Lung Cancer

Excerpt:
......
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Erlotinib and AT-101 in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutations

Excerpt:
...- Presence of exon 19 or exon 21 EGFR activating mutation....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Erlotinib Hydrochloride in Treating Non-Small Cell Lung Cancer That is Metastatic or Cannot be Removed by Surgery in Patients With HIV Infection

Excerpt:
...- Participants must have known HIV infection and histologically confirmed non-small cell lung cancer that is metastatic or unresectable; patients will be eligible regardless of tumor EGFR mutation status...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors

Excerpt:
...Overall Survival (OS)`Disease-free Survival in Participants With EGFR Mutation - Positive Tumors`Overall Survival in Participants With EGFR Mutation - Positive Tumors`Number of Participants With Adverse Events (AEs)...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

ARQ 197 Plus Erlotinib in Patient With Locally Advanced or Metastatic EGFR Mutation-positive Non-small-cell Lung Cancer

Excerpt:
...- Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) NSCLC with EGFR activating mutation....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Evaluate Erlotinib Efficacy and Safety as the 2nd/3rd Treatment in NSCLC With EGFR M(-) and C-met(-)

Excerpt:
...Neither with EGFR mutation nor c-met expression on Ventana Benchmark instrument(...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Study of Polyphenon E in Addition to Erlotinib in Advanced Non Small Cell Lung Cancer

Excerpt:
...Phase I: Response rate`Phase 1: Progression Free Survival`Phase 2: Progression Free Survival`Phase 2: Overall Survival`Phase 2: Correlation between level of EGFR expression on the original tumor tissue and the presence of EGFR mutations in exons 18, 19 and 21 in serum DNA and original tumor tissue with the treatment response and outcome.`...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Erlotinib With Concurrent Brain Radiotherapy and Secondary Brain Radiotherapy After Recurrence With Erlotinib in NSCLC Non-increased-intracranial-pressure Symptomatic Brain Metastases

Excerpt:
...Patients in initial treatment should be detected EGFR mutation; 8....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Phase II Study to Assess Efficacy of Combined Treatment With Erlotinib (Tarceva) and Silybin-phytosome (Siliphos) in Patients With EGFR Mutant Lung Adenocarcinoma

Excerpt:
...Histological or cytologic diagnosis of stage IV lung adenocarcinoma and confirmed EGFR mutation...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Theranostic Tool During Erlotinib Treatment in Non-small Cell Lung Cancer Patient

Excerpt:
...- EGFR mutation status known with...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study of the Combination of Erlotinib and Pertuzumab in Patients With Relapsed Non-small Cell Lung Cancer

Excerpt:
...- Availability and willingness to provide sufficient tumor tissue for testing for epidermal growth factor receptor (EGFR) mutations, and other human epidermal growth factor receptor (HER) pathway and NSCLC-related biomarkers....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Phase I/II of Oral Vorinostat Combination With Erlotinib in NSCLC Patients With EGFR Mutations With DP After Erlotinib.

Excerpt:
...Have demonstrated mutations at epidermal growth factor receptor (EGFR) at Exon 19 or Exon 21 (Exon 19 mutations characterized by in-frame deletions (747-750), and Exon 21 mutations resulting in L858R substitutions)....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Laboratory Test in Predicting Response to Erlotinib in Patients With Relapsed Metastatic or Unresectable Non-Small Cell Lung Cancer That Did Not Respond to Previous Treatment

Excerpt:
...Extent of inhibition of epidermal growth factor receptor (EGFR) and AKT phosphorylation by erlotinib hydrochloride`Toxicity`Frequency and proportion of patients with complete response, partial response, stable disease, and progressive disease`Comparison of ex vivo and in vivo effects of erlotinib hydrochloride`Proportion of patients with EGFR gene amplification and gene mutation with an ex vivo response and clinical response...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC)

Excerpt:
...- Tumor EGFR mutation...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

First-Line EGFR-1 Tyrosine Kinase Inhibition in Patients With NSCLC With Mutant EGFR Gene

Excerpt:
...Establish clinical benefit (progression free survival) of first line RTKI in patients with stage IV and stage IIIB NSCLC not eligible for curative-intent treatment (chemo-radiotherapy) carrying a mutant EGFR-1....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Erlotinib as Neoadjuvant Treatment in Patients With Stage ⅢA N2 NSCLC With Activating EGFR Mutation.

Excerpt:
...The biopsy specimen shows EGFR mutation in exon 19 or 21 by DNA sequencing....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung

Excerpt:
...- Must be willing to undergo epidermal growth factor receptor (EGFR) mutation testing of her tumor...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Phase Ⅲ Trial of WBRT Versus Erlotinib Concurrent Whole-brain Radiation Therapy as first-line Treatment for Patients With Multiple Brain Metastases From Non-small-cell Lung Cancer(ENTER): a Multicentre, Open-label, Randomised Study

Excerpt:
...the pathological diagnosis of non-small cell lung cancer and detection of pulmonary primary ARMs / sequencing EGFR mutation; 3....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Erlotinib in Patients With Resected, Early Stage NSCLC With Confirmed Mutations in the EGFR

Excerpt:
...- Sufficient tumor tissue available for EGFR mutation analysis...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Low Dose Daily Erlotinib in Combination With High Dose Twice Weekly Erlotinib in Patients With EGFR-Mutant Lung Cancer

Excerpt:
...- Documented presence of EGFR mutation confirmed by MSKCC or a local facility....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations

Excerpt:
...- Locally advanced or metastatic NSCLC with EGFR mutations...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study on the Correlation Between Tarceva (Erlotinib) - Induced Rash and Efficacy in EGFR Mutated Participants With Advanced Non-Small Cell Lung Cancer Receiving First-Line Therapy

Excerpt:
...- Presence of epidermal growth factor receptor (EGFR) mutations...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study of Tarceva (Erlotinib) as First Line Therapy in Participants With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations

Excerpt:
...- Presence of mutation(s) in exon 18 through exon 21 of epidermal growth factor receptor (EGFR), (except T790M single mutation only)...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present EGFR Mutations

Excerpt:
...- Locally advanced or metastatic (stage III/IV) non-small cell lung cancer with EGFR mutations...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Erlotinib Hydrochloride and Cabozantinib-s-Malate Alone or in Combination as Second or Third Line Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer

Excerpt:
...- Tumor with a sensitizing mutation in epidermal growth factor receptor (EGFR), defined as follows:...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Neoadjuvant Erlotinib for Operable Stage II or IIIA NSCLC With EGFR Mutations

Excerpt:
...- EGFR exon 19 or 21 mutations...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Tivantinib Plus Erlotinib Versus Placebo Plus Erlotinib for the Treatment of Non-squamous, Non-small-cell Lung Cancer

Excerpt:
...EGFR and KRAS mutation status prior to randomization, and MET status post randomization...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Stereotactic Radiosurgery or Other Local Ablation Then Erlotinib in Epidermal Growth Factor Receptor (EGFR)

Excerpt:
...- Histologically or cytologically confirmed stge IV EGFR-mutant NSCLC...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Erlotinib Hydrochloride Before Surgery in Treating Patients With Stage III Non-Small Cell Lung Cancer

Excerpt:
...- Activating mutation in EGFR...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Multicenter trial to compare erlotinib vs mono-chemotherapy in the third-line treatment of non-small cell lung cancer (NSCLC) patients with EGFR-mutated or unknown Studio di confronto tra erlotinib e monochemioterapia nel trattamento di terza linea del tumore polmonare non a piccole cellule (NSCLC) con EGFR non-mutato o sconosciuto

Excerpt:
...• State of EGFR - mutated or unknown . ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

MK2206 and Erlotinib Hydrochloride in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Progressed After Previous Response to Erlotinib Hydrochloride Therapy

Excerpt:
...epidermal growth factor receptor (EGFR) mutational status (either wild-type or positive for an activating mutation) will be determined for all patients on this study; commercial assays for EGFR mutation status are allowed; knowledge of EGFR mutational status is...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Single-arm Study to Evaluate the Efficacy of Intercalated Combination of Chemotherapy and Erlotinib as First-line Treatment for Patients With Non-Small-Cell Lung Cancer

Excerpt:
...EGFR mutation-positive (EGFR exon-18, exon-19 or exon-21); 5. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Cetuximab in Patients With Lung Adenocarcinoma Receiving Erlotinib That Have Developed "Acquired Resistance" to Erlotinib

Excerpt:
...- A documented mutation in EGFR exons 19 or 21....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study to Assess the Efficacy of Erlotinib for Leptomeningeal Carcinomatosis in EGFR Mutation Positive Non-small Cell Lung Cancer

Excerpt:
...A patients with EGFR mutation (including exon 19 deletion, L858R) 5....
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Erlotinib versus gemcitabine plus cisplatin as neoadjuvant treatment of stage IIIA-N2 EGFR-mutant non-small-cell lung cancer: final overall survival analysis of the EMERGING-CTONG 1103 randomised phase II trial

Published date:
02/24/2023
Excerpt:
...the updated analysis of CTONG1103 indicated that erlotinib continued to improve PFS and OS numerically compared with platinum-based chemotherapy. Moreover, there was no evidence of cumulative toxicity in erlotinib during the long-term follow-up. The present results support the use of erlotinib in both the neoadjuvant and adjuvant settings for resectable stage IIIA-N2 EGFR-mutant NSCLC.
DOI:
https://doi.org/10.1038/s41392-022-01286-3
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Randomised controlled trial of first-line tyrosine-kinase inhibitor (TKI) versus intercalated TKI with chemotherapy for EGFR-mutated nonsmall cell lung cancer

Published date:
10/17/2022
Excerpt:
Intercalating erlotinib with cisplatin-pemetrexed provides a longer PFS compared to erlotinib alone in EGFR-mutated NSCLC at the expense of more toxicity.
Secondary therapy:
Chemotherapy
DOI:
10.1183/23120541.00239-2022
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Randomised controlled trial of first-line tyrosine-kinase inhibitor (TKI) versus intercalated TKI with chemotherapy for EGFR-mutated nonsmall cell lung cancer

Published date:
10/17/2022
Excerpt:
Median PFS was 13.7 months (95% CI 5.2-18.8) for CPE and 10.3 months (95% CI 7.1-15.5; hazard ratio (HR) 0.62, 95% CI 0.25-1.57) for erlotinib monotherapy; when compensating for number of days receiving erlotinib, PFS of the CPE arm was superior (HR 0.24, 95% CI 0.07-0.83; p=0.02). ORR was 64% for CPE versus 55% for erlotinib monotherapy. Median overall survival was 31.7 months (95% CI 21.8-61.9 months) for CPE compared to 17.2 months (95% CI 11.5-45.5 months) for erlotinib monotherapy (HR 0.58, 95% CI 0.22-1.41 months)....Intercalating erlotinib with cisplatin-pemetrexed provides a longer PFS compared to erlotinib alone in EGFR-mutated NSCLC at the expense of more toxicity.
Secondary therapy:
cisplatin + pemetrexed
DOI:
10.1183/23120541.00239-2022
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Updated Overall Survival and Exploratory Analysis From Randomized, Phase II EVAN Study of Erlotinib Versus Vinorelbine Plus Cisplatin Adjuvant Therapy in Stage IIIA Epidermal Growth Factor Receptor+ Non–Small-Cell Lung Cancer

Published date:
08/26/2022
Excerpt:
With erlotinib, the respective 5-year DFS by Kaplan-Meier analysis was 48.2% (95% CI, 29.4 to 64.7) and 46.2% (95% CI, 27.6 to 62.9) in the intention-to-treat and per-protocol populations. The median OS was 84.2 months with erlotinib versus 61.1 months with chemotherapy (hazard ratio, 0.318; 95% CI, 0.151 to 0.670). The 5-year survival rates were 84.8% and 51.1% with erlotinib and chemotherapy, respectively...this study is the first to demonstrate clinically meaningful OS improvement with adjuvant erlotinib compared with chemotherapy in R0 stage III EGFR+ non-small-cell lung cancer.
DOI:
10.1200/JCO.22.00428
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Evaluation of Progression-Free Survival and Overall Survival of Epidermal Growth Factor Receptor-Positive Metastatic Lung Adenocarcinoma Patients Treated with Erlotinib

Published date:
04/06/2022
Excerpt:
The mean PFS was 11.44±9.35months and, the OS of patients was 21.78±14.35months…according to the findings of the present study, the use of erlotinib can be considered as an effective first-line treatment option with controllable toxicity in patients with advanced or metastatic NSCLC with positive EGFR.
DOI:
10.47176/mjiri.36.31
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Tumor Growth Rate After Nadir Is Associated With Survival in Patients With EGFR-Mutant Non–Small-Cell Lung Cancer Treated With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor

Published date:
10/14/2021
Excerpt:
The OS of 48 patients with slow tumor growth (≤ 0.12/mo) was significantly longer compared with 23 patients with fast tumor growth (> 0.12/mo; median OS: 37.8 v 25.0 months; P = .0012)….In patients with EGFR-mutant advanced NSCLC treated with erlotinib, slower tumor growth rates after nadir were associated with longer OS, providing a rationale for using tumor growth rates to guide precision therapy for lung cancer.
DOI:
10.1200/PO.21.00172
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Radiomic Signature to Predict Outcomes in EGFR-Mutant Non-Small Cell Lung Cancer

Published date:
08/18/2021
Excerpt:
A total of 44 patients with EGFR variant–positive NSCLC receiving EGFR-TKI therapy were included...25 (66%) presented PFS of more than 12 months (age at treatment start: 74 (9) years; 76% females; 16 on erlotinib, 4 on afatinib, 4 on osimertinib, 1 on gefitinib).
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Associated factors for poor response in advanced EGFR-mutated NSCLC patients under tirosine kinase inhibitors: Peruvian real-world data

Published date:
05/19/2021
Excerpt:
CONTRADICTING EVIDENCE: ...advanced NSCLC patients harboring EGFR mutations that have received TKI as first line therapy…Odds ratio for poor response decreases 95% with erlotinib (OR = 0.05, IC95% = 0.00-0.58; p = 0.016)….According to our data, poor response is associated with uncommon EGFR mutations, TKI agent (erlotinib)...
DOI:
10.1200/JCO.2021.39.15_suppl.e21214
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Predictors of response in EGFR-mutant metastatic non-small cell lung cancer patients treated with tyrosine kinase inhibitors.

Published date:
05/19/2021
Excerpt:
Data of the EGFR-mutant lung cancer patients were evaluated retrospectively....The patients received erlotinib (83.8%) or other EGFR inhibitors (16.2%) for treatment. Median overall survival was 30.8 (range 20.2-41.4) months. Overall response rate (complete or partial response) was 61.9%...real-life outcomes of the patients with EGFR-mutant metastatic non-small cell lung cancer.
DOI:
10.1200/JCO.2021.39.15_suppl.e21149
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Updated overall survival (OS) and exploratory analysis from the randomized, phase II EVAN study of erlotinib (E) versus vinorelbine plus cisplatin (NP) as adjuvant therapy in Chinese patients with stage IIIA EGFR+ NSCLC.

Published date:
05/19/2021
Excerpt:
E improved OS and 5-year survival rate compared with NP in ITT population. The median OS was 84.2m (95% CI, 78.1,-) with E vs 61.1m (95% CI, 39.6-82.1) with NP (HR, 0.318; 95% CI, 0.151-0.670)....This is the first randomized study of EGFR-TKI to demonstrate a clinically meaningful improvement in OS vs chemotherapy in stage III EGFR+ NSCLC (5-year survival rate 84.8% in E vs 51.1% in NP).
DOI:
10.1200/JCO.2021.39.15_suppl.8520
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

68P - Comparison of first-generation EGFR-TKIs (gefitinib, erlotinib, and icotinib) as adjuvant therapy in resected NSCLC patients with sensitive EGFR mutations

Published date:
03/17/2021
Excerpt:
The median DFS of stage II/III patients in the gefitinib, erlotinib and icotinib group were 36.1 months (95% CI, 23.9–49.4), 42.8 months (95% CI, 29.6–97.8), and 32.5 months (95% CI, 23.9–49.4), respectively...This first and largest real-world study showed that gefitinib, erlotinib, and icotinib demonstrated comparable clinical effectiveness as adjuvant therapy in completely resected patients with EGFR mutated NSCLC.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Efficacy and safety of anti-angiogenic drugs combined with erlotinib in the treatment of advanced non-small cell lung cancer: a meta-analysis of randomized clinical trials

Published date:
02/02/2021
Excerpt:
We collected and compared RCTs on antiangiogenic drugs combined with erlotinib (A + E) for NSCLC…The subgroup analysis showed that patients with epidermal growth factor receptor (EGFR) mutations and patients with adenocarcinoma could benefit from combination therapy...
Secondary therapy:
Angiogenesis inhibitor
DOI:
10.21037/apm-20-1621
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Whole Brain Radiotherapy With and Without Concurrent Erlotinib in NSCLC with Brain Metastases: a multicentre, open-label, randomized, controlled phase 3 Trial

Published date:
12/17/2020
Excerpt:
CONTRADICTING EVIDENCE: In EGFR-mutant patients, iPFS (14.6 versus 12.8 months; p=0.164), PFS (8.8 versus 6.4 months; p=0.702) and OS (17.5 versus 16.9 months; p=0.221) were not significantly improved in combination group over WBRT-alone….Concurrent erlotinib with WBRT didn't improve iPFS and excessive CF detriment either in the intent-to-treat (ITT) population or in EGFR-mutant patients compared with WBRT-alone...
DOI:
10.1093/neuonc/noaa281
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Survival outcomes and symptomatic central nervous system (CNS) metastasis in EGFR-mutant advanced non-small cell lung cancer without baseline CNS metastasis: Osimertinib vs. first-generation EGFR tyrosine kinase inhibitors

Published date:
11/05/2020
Excerpt:
There were 813 patients enrolled, with 562, 106, and 32 received first-line gefitinib, erlotinib, and osimertinib, respectively, while 113 received second-line osimertinib. At a median follow-up of 18.1 months, the median OS was 45.5 months.
DOI:
10.1016/j.lungcan.2020.10.018
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Phase I/II study of erlotinib plus S-1 for patients with previously treated non-small cell lung cancer: Thoracic Oncology Research Group (TORG) 0808/0913

Published date:
08/15/2020
Excerpt:
Five of these subjects were EGFR-mutation positive. Four subjects were enrolled at S-1 dose level 1 and 3 were enrolled at S-1 dose level 2. No dose-limiting toxicities were observed in these subjects. The RD was decided as erlotinib 150 mg/body and S-1 80 mg/m2. In phase I, 5 subjects achieved partial response, and the ORR was 71.4%.
Secondary therapy:
gimeracil/oteracil/tegafur
DOI:
10.1007/s10637-020-00985-4
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

CTONG 1103: Erlotinib versus gemcitabine plus cisplatin as neo-adjuvant treatment for stage IIIA-N2 EGFR-mutation non-small cell lung cancer (EMERGING): A randomised study

Published date:
10/01/2018
Excerpt:
Neoadjuvant/adjuvant erlotinib improved ORR, and significantly prolonged PFS compared with GC chemotherapy in patients with stage IIIA-N2 EGFR mutation NSCLC.
DOI:
https://doi.org/10.1093/annonc/mdy424.058
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

Impact of Systematic EGFR and KRAS Mutation Evaluation on Progression-Free Survival and Overall Survival in Patients with Advanced Non–Small-Cell Lung Cancer Treated by Erlotinib in a French Prospective Cohort (ERMETIC Project—Part 2)

Excerpt:
EGFR and KRAS mutations were significantly associated with PFS (HR = 0.5, CI 0.3-0.7 and HR = 1.2, CI 0.8-1.8, respectively, versus no mutation; LR p = 0.001). In the OS model, adjusted HR was 0.7 (0.4-1.0) for EGFR mutation and 1.7 (1.1-2.4) for KRAS (LR p = 0.004).
DOI:
https://doi.org/10.1097/JTO.0b013e318265b2b5
Evidence Level:
Sensitive: C3 – Early Trials
New
Source:
Title:

EGFR gene copy number as a predictive biomarker for patients receiving tyrosine kinase inhibitor treatment: a systematic review and meta-analysis in non-small-cell lung cancer

Excerpt:
...EGFR gene copy number by fluorescent or chromogenic in situ hybridization in patients with advanced or recurrent NSCLC treated with the TKIs erlotinib or gefitinib...Among TKI-treated patients, increased EGFR gene copy number appears to be associated with improved survival outcomes.
DOI:
10.1093/annonc/mdq432
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

Impact of Epidermal Growth Factor Receptor and KRAS Mutations on Clinical Outcomes in Previously Untreated Non–Small Cell Lung Cancer Patients: Results of an Online Tumor Registry of Clinical Trials

Excerpt:
Of the 84 patients harboring a sensitizing EGFR mutation who were treated with either erlotinib or gefitinib, 56 patients (67%) achieved an objective response (1 complete response, 55 partial response). 
DOI:
10.1158/1078-0432.CCR-09-0888
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

Insight into binding mechanisms of EGFR allosteric inhibitors using molecular dynamics simulations and free energy calculations

Excerpt:
... epidermal growth factor receptor (EGFR) kinase domain mutations are a common cause of non-small-cell lung cancer (NSCLC), a major subtype of lung cancers. Patients harboring most of these mutations respond well to the EGFR inhibitors Gefitinib and Erlotinib initially, but soon develop resistance to them due to the emergence of the gatekeeper mutation T790M.
DOI:
10.1080/07391102.2018.1552197
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

Efficacy of erlotinib and its effects on the quality of life of older patients with epidermal growth factor receptor-mutant non-small cell lung cancer: A prospective, multicenter, dose-modification study

Excerpt:
A prospective, multicenter, phase II clinical trial was carried out in patients aged ≥75 years with epidermal growth factor receptor-mutant non-small cell lung cancer. Initially, 100 mg/day erlotinib was administered orally; if well tolerated, it was increased to 150 mg/day....The median progression-free survival was 17.8 months, response rate was 63.6% and median overall survival was 27.8 months.
DOI:
10.1111/ggi.14243
Evidence Level:
Sensitive: C4 – Case Studies
Title:

Induction EGFR tyrosine kinase inhibitors prior to definitive chemoradiotherapy in unresectable stage III EGFR-mutated non-small cell lung cancer

Published date:
11/17/2022
Excerpt:
We evaluated the efficacy and safety of induction EGFR TKIs administered before concurrent CRT in a retrospective series of patients with unresectable locally advanced EGFR-mutated NSCLC….Of six patients, three received erlotinib and three osimertinib as induction therapy before CRT....One patient had a complete response to induction erlotinib and continued erlotinib for 4 years until local progression, which was treated with CRT.
DOI:
10.1016/j.ctarc.2022.100659