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.

First-line treatment of EGFR-mutated NSCLC: Erlotinib/bevacizumab represents a front-line treatment option in patients with EGFR-mutated tumours.

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).

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...

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).

...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...

...- Presence of epidermal growth factor receptor (EGFR) mutations...

...- Met-positive status and results of epidermal growth factor receptor (EGFR)-activating mutation testing....

...- Locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer...

...- Tumor EGFR mutation...

...the pathological diagnosis of non-small cell lung cancer and detection of pulmonary primary ARMs / sequencing EGFR mutation; 3....

...• State of EGFR - mutated or unknown . ...

...- Non-small cell lung cancer with an EGFR activating mutation...

...Histological or cytologic diagnosis of stage IV lung adenocarcinoma and confirmed EGFR mutation...

...EGFR mutation-positive (EGFR exon-18, exon-19 or exon-21); 5. ...

...--Participants with positive or pending EGFR mutation on plasma genotyping performed at the central lab are eligible for enrollment, and will...

...Progression-free Survival and Overall Survival`Evaluation of EGFR Mutations in Tumor Biopsies and Correlation of EGFR Mutations With Objective Radiographic Responses....

...- Sufficient tumor tissue available for EGFR mutation analysis...

...- Documented presence of EGFR mutation confirmed by MSKCC or a local facility....

...- Locally advanced or metastatic NSCLC with EGFR mutations...

...- Presence of mutation(s) in exon 18 through exon 21 of epidermal growth factor receptor (EGFR), (except T790M single mutation only)...

...- EGFR mutation status must be confirmed for participation in the study....

...- Histologically or cytologically confirmed metastatic or unresectable locally advanced NSCLC with known sensitive EGFR mutations....

...- Documentation of a sensitizing mutation of the epidermal growth factor receptor....

...- Patients must have lung cancer with a documented EGFR activating mutation (exon 19 deletion, L858R, L861Q)...

...The biopsy specimen shows EGFR mutation in exon 19 or 21 by DNA sequencing....

...- EGFR mutation-positive disease according to local laboratory testing...

...EGFR activating mutations in exon 18, 19 or 21were detected in tumor tissue or plasma....

...- Confirmed with Exon 19 deletion or L858R EGFR mutation...

...- Results of endothelial growth factor receptor (EGFR)-activating mutation testing...

...EGFR mutation status are allowed if they fulfil the following criteria:...

...- Patients must have received at least one platinum-containing regimen for the treatment of advanced or metastatic disease (except for EGFR-mutant patients)....

...- Patients must have tissue available for EGFR-mutation status testing (if...

...- Presence of exon 19 or exon 21 EGFR activating mutation....

...- Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) NSCLC with EGFR activating mutation....

...- EGFR mutation status known with...

...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)....

...- 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....

...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)...

...Neither with EGFR mutation nor c-met expression on Ventana Benchmark instrument(...

...- Locally advanced or metastatic (stage III/IV) non-small cell lung cancer with EGFR mutations...

...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.`...

...- 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....

...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...

...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....

...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...

...- 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....

...The tumor harbors an exon 19 deletion or exon 21 L858R mutation in EGFR, confirmed locally....

...harbouring deletions in the exon 19 or mutation in the exon 21 in the TK of the EGFR....

...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...

...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....

...- Diagnosis of locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the EGFR...

...- 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...

...- Exon 19 deletion or exon 21 activating mutation in EGFR...

...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...

...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...

...- Presence of one of the EGFR activating mutations in the tumor (exon 19 deletion or L858R, G719X or L861Q)...

...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....

...- 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;...

...Number of participants with EGFR mutation (L858R/ exon 19 deletion) and who achieved clinical benefit status was reported. ...

...- Must be willing to undergo epidermal growth factor receptor (EGFR) mutation testing of her tumor...

...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. ...

...have documented EGFR mutation or EGFR gene amplification, regardless of demographic or clinical characteristics, who have had...

...histologically confirmed EGFR exon 19 deletion or exon 21 mutation in the diagnostic phase of the study...

...Histology and cytology confirmed with unfavorable surgical locally advanced stage (stage IIIB) or metastatic NSCLC (IV), Sensitive EGFR gene mutation 5....

...EGFR mutation:...

...- 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...

...Patients in initial treatment should be detected EGFR mutation; 8....

...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...

...- A documented mutation in EGFR exons 19 or 21....

...A patients with EGFR mutation (including exon 19 deletion, L858R) 5....

...- Tumor with a sensitizing mutation in epidermal growth factor receptor (EGFR), defined as follows:...

...- 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)...

...- EGFR exon 19 or 21 mutations...

...- A tumor that harbors an EGFR mutation known to be associated with drug sensitivity (i.e. G719X, exon 19 deletion, L858R, L861Q)...

...EGFR and KRAS mutation status prior to randomization, and MET status post randomization...

...- Histologically or cytologically confirmed stge IV EGFR-mutant NSCLC...

...- Activating mutation in EGFR...

...- Presence of known sensitizing mutations in EGFR TK domain...

...- a documented somatic activating mutation in EGFR (including but...

...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.

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.

Intercalating erlotinib with cisplatin-pemetrexed provides a longer PFS compared to erlotinib alone in EGFR-mutated NSCLC at the expense of more toxicity.

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.

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.

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.

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).

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.

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).

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)...

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.

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...

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...

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.

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%.

Neoadjuvant/adjuvant erlotinib improved ORR, and significantly prolonged PFS compared with GC chemotherapy in patients with stage IIIA-N2 EGFR mutation NSCLC.

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).

...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.

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). 

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.

... 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.

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.