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Association details:
| Biomarker: | EGFR mutation |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Keytruda (pembrolizumab) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Published date:
07/17/2015
Excerpt:
Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving Keytruda.
Source:
Excerpt:
Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
Source:
Title:
Phase II randomized, open, controlled trial for PD-1 monoclonal antibody combined with platinum-containing chemotherapy versus PD-1 monoclonal antibody for first-line treatment of recurrent or advanced metastatic non-small cell lung cancer with positive PD-L1 expression
Excerpt:
...Patients with negative EGFR-sensitive mutation and ALK fusion gene test results by genetic testing; 7. ...
Trial ID:
Source:
Title:
Pembrolizumab in Patients With Metastatic Non-squamous Non-small Cell Lung Cancer
Excerpt:
...If the patient has a sensitizing EGFR mutation or ALK rearrangement, the patient must have received at least one prior targeted therapy for metastatic disease (ie, EGFR TKI therapy or ALK TKI therapy, respectively)....
Trial ID:
More C2 evidence
Source:
Title:
Study of Pembrolizumab Versus Docetaxel in Participants Previously Treated for Non-Small Cell Lung Cancer (MK-3475-033/KEYNOTE-033)
Excerpt:
...- Has documentation of epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase (ALK) translocation status...
Trial ID:
Source:
Title:
Genetic Predictors of Benefit to Pembrolizumab
Excerpt:
...- Chemotherapy naïve NSCLC patients.For NSCLC patients with lung adenocarcinoma, tumors must be Epidermal Growth Factor Receptor (EGFR) and Anaplastic Lymphoma Kinase (ALK) wild-type; if a Kirsten Ras (KRAS) mutation is detected, EGFR and ALK testing is...
Trial ID:
Source:
Title:
Maintenance Pembrolizumab at Usual or Low doSE in Non-squamous Lung Cancer: a Non-inferiority Study
Excerpt:
...In the presence of an EGFR mutation, an ALK or ROS1 rearrangement the patient must have received at least one specific targeted therapy line....
Trial ID:
Source:
Title:
Pembrolizumab Plus Pemetrexed for Elderly Patients With Non-Sq NSCLC With PD-L1 < 50%: CJLSG1901
Excerpt:
...Without activating mutation in EGFR or ALK chromosomal translocation....
Trial ID:
Source:
Title:
Study to Evaluate the Safety of Pembrolizumab in Participants With Unresectable or Metastatic Melanoma or Non-small Cell Lung Cancer in India (MK-3475-593/KEYNOTE-593)
Excerpt:
...- Has received an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (either erlotinib, gefitinib, or afatinib) if they have an EGFR sensitizing mutation...
Trial ID:
Source:
Title:
A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001)
Excerpt:
...Participants must have been tested for mutations affecting EGFR and/or anaplastic lymphoma kinase (ALK)....
Trial ID:
Source:
Title:
Pembrolizumab in Treating Patients With EGFR Mutant, Tyrosine Kinase Inhibitor Naive Advanced Non-Small Cell Lung Cancer
Excerpt:
...- Have an EGFR mutation (sensitizing or non-sensitizing)...
Trial ID:
Source:
Title:
PULSE: Pembrolizumab en maintenance à dose conventionnelle ou adaptée dans le cancer bronchique non à petites cellules : une étude de non infériorité
Excerpt:
...To be checked before the induction phase (only for patient included before induction phase):1.Histologically or cytologically confirmed diagnosis of non-squamous non-small cell lung cancer (NSCLC).2.Non-operable / non-irradiable stage III or stage IV.3.Patient must be eligible to receive 3 or 4 cycles of induction treatment combination with pembrolizumab plus platinum (cisplatin or carboplatin) and pemetrexed.4.In the presence of an EGFR mutation, an ALK or ROS1 rearrangement the patient must have received at least one specific targeted therapy line.5. ...
Trial ID:
Source:
Title:
A study evaluating the safety and efficacy of radium-223 dichloride in combination with pembrolizumab in lung cancer patients
Excerpt:
...Phase 2 Cohort 1: no Epidermal Growth Factor Receptor (EGFR) sensitization (activating) mutation or anaplastic lymphoma kinase (ALK)/ROS1 rearrangement. ...
Trial ID:
Source:
Title:
A study investigating the use of IO102-IO103 in combination with pembrolizumab for patients with metastatic Non-Small Cell Lung Cancer (NSCLC), Squamous Cell Carcinoma of Head and Neck (SCCHN), or metastatic Urothelial Bladder Cancer (mUBC)
Excerpt:
...Patients with histologically or cytologically confirmed:Metastatic NSCLC (adenocarcinoma) (Arm A), who have not received prior systemic treatment for their metastatic disease and who have:• no known sensitizing genetic aberrations where there are approved therapies (such as EGFR, KRAS G12C, BRAF V600E, MET skipping mutations, and RET mutations or rearrangements)orMetastatic SCCHN (Arm B) with no prior therapy and who have:• Histologically- or cytologically-confirmed recurrent (without metastases) or metastatic SCCHN considered incurable by local therapies. ...
Trial ID:
Source:
Title:
Study of Pembrolizumab (MK-3475) Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (MK-3475-024/KEYNOTE-024)
Excerpt:
...- Histological or cytological diagnosis of Stage IV NSCLC lacking epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) translocation, and received...
Trial ID:
Source:
Title:
Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers
Excerpt:
...- Tumors with epidermal growth factor receptor mutation positive or anaplastic lymphoma kinase fusion oncogene positive treated with a tyrosine kinase inhibitor are permitted; however, subjects should have progressed on or be intolerant to the targeted therapy....
Trial ID:
Source:
Title:
MK-3475 in Combination With Docetaxel vs Docetaxel Alone in Non-Small Cell Lung Cancer Patients
Excerpt:
...Subjects with a known mutation of EGFR and received EGFR TKI (erlotinib , gefitinib or experimental) and double platinum-based chemotherapy ( regardless of the order of administration)....
Trial ID:
Source:
Title:
A trial comparing the pembrolizumab platinum based chemotherapy combination with pembrolizumab monotherapy in first line treatment of non small-cell lung cancer (NSCLC) patients Etude comparant l’association chimiothérapie à base de sels de platine et pembrolizumab au pembrolizumab en monothérapie, en première ligne de traitement de cancers broncho-pulmonaires non à petites cellules (CBPNC)
Excerpt:
...For non-squamous NSCLCs and non-smoking squamous NSCLCs, no known activating mutations of EGFR and no ALK or ROS1 rearrangements.5. ...
Trial ID:
Source:
Title:
Pembrolizumab Monotherapy versus Sacituzumab Govitecan in Combination with MK-3475 for PD-L1 TPS ≥50% Metastatic NSCLC
Excerpt:
...Has confirmation that EGFR-, ALK-, or ROS-1-directed therapy is not indicated as primary therapy (documentation of the absence of tumor-activating EGFR mutations [eg, DEL19 or L858R], AND absence of ALK and ROS-1 gene rearrangements).4. ...
Trial ID:
Source:
Title:
Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non–Small Cell Lung Cancer
Excerpt:
...Note:Tumor testing for EGFR or ALK mutations is required if status is unknown 4)Have no known genomic alterations in ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), RET mutations, or other actionable driver oncogenes with approved therapies (actionable genomic alteration). ...
Trial ID:
Source:
Title:
Phase II study to test Pembrolizumab (MK-3475) in first line treatment of advanced NSCLC patients with PD-L1 low tumors (
Excerpt:
...Do not have an EGFR sensitizing (activating) mutation or ALK translocation and have a PD-L1 “low” (ing treatment. ...
Trial ID:
Source:
Title:
Stereotactic Body Radiation in combination with immunotherapy-chemotherapy in patients with Metastatic Non-Small Cell Lung Cancer. Radioterapia stereotassica in associazione alla Immunoterapia-chemioterapia in pazienti affetti da Cancro Metastatico del Polmone non a Piccole Cellule.
Excerpt:
...- Histologic confirmation of NSCLC by biopsy or cytology (primary cancer are eligible: squamous cell carcinoma, adenocarcinoma; no sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) gene translocation; stage IV according to the 8th version of the IASLC system); - Age >= 18 years; - Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; - At least two lesions measurable according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1; - Life expectancy of at least 3 months; - Signature of informed consent form; - Patients must have adequate organ function. ...
Trial ID:
Source:
Title:
Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer
Excerpt:
...- Patients with known EGFR mutations (except exon 20 insertion), BRAF mutations (V600) or ALK or ROS1 translocations or other driver mutations that can be treated with oral tyrosine kinase inhibitors are excluded...
Trial ID:
Source:
Title:
SBRT and Oncolytic Virus Therapy Before Pembrolizumab for Metastatic TNBC and NSCLC
Excerpt:
...Epidermal growth factor receptor (EGFR)/anaplastic lymphoma kinase (ALK) mutation-negative NSCLC patients and NSCLC patients with EGFR or ALK genomic tumor aberrations that have failed FDA-approved targeted therapy for these aberrations will be eligible for enrollment in the study....
Trial ID:
Source:
Title:
Pembrolizumab for Metastatic NSCLC Patients Expressing PD-L1 Who Have Their Own PDX
Excerpt:
...Patients with sensitive EGFR mutations should have disease progression on at least one of EGFR TKIs (including but...
Trial ID:
Source:
Title:
Pembrolizumab in Combination With Platinum-Based Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Patients With Targetable Genetic Alterations, Previously Treated With Appropriate Targeted Agents, With Progressive Disease
Excerpt:
...- Cohort-specific: Cohort 1- EGFR mutation positive NSCLC patients previously treated with appropriate targeted therapy with progressive and measurable disease per RECIST 1.1 criteria tumor....
Trial ID:
Source:
Title:
Effect of Pembrolizumab With or Without Carboplatin and Paclitaxel on Immune Response in Patients With Recurrent or Stage IIIB-IV Non-small Cell Lung Cancer
Excerpt:
...Patients with epidermal growth factor (EGFR) mutation, anaplastic lymphoma kinase (ALK) gene rearrangement or ROS1 translocation must have received an approved EGFR, ALK, or ROS1-directed therapy and have signs of disease progression prior to receiving pembrolizumab....
Trial ID:
Source:
Title:
Phase II Trial of Continuation Therapy in Advanced NSCLC
Excerpt:
...- Subjects whose tumors harbor a mutation in EGFR exon 19 or 21 or have gene rearrangements in ALK or ROS1 must have already been treated with standard targeted therapies....
Trial ID:
Source:
Title:
Optimal Sequencing of Pembrolizumab (MK-3475) and Standard Platinum-based Chemotherapy in First-Line NSCLC
Excerpt:
...In patients with non-squamous non-small cell lung cancer, investigators must be able to produce source documentation of the EGFR mutation status or ALK translocation status....
Trial ID:
Source:
Title:
Biomarkers of Response to Pembrolizumab Combined With Chemotherapy in Non-Small Cell Lung Cancer (KEYNOTE-782, MK-3475-782)
Excerpt:
...Documentation of the absence of tumor activating EGFR mutations, BRAF mutations, ALK gene rearrangements, and ROS1 gene rearrangements is required....
Trial ID:
Less C2 evidence
Source:
Title:
Comparison of Chemotherapy Plus Pembrolizumab vs. Chemotherapy Alone in EGFR-Mutant Non-small-Cell Lung Cancer Patients
Published date:
12/28/2022
Excerpt:
Improved median overall survival was also observed in patients receiving pembrolizumab plus chemotherapy (26.7 [95% CI 22.6-30.8] vs. 13.4 months [95% CI 10.4-16.4], HR, 0.49 [95% CI 0.31-0.75], P = .0052). In addition, the overall response rate was higher in patients treated with than patients treated without pembrolizumab (34.1% and 20.7%, respectively)....The combination of pembrolizumab with chemotherapy is associated with improved efficacy and survival in patients with EGFR-mutant NSCLC after TKI resistance...
Secondary therapy:
Chemotherapy
DOI:
10.1016/j.cllc.2022.12.003
Source:
Title:
OA09.03 - Pembrolizumab in Combination With Platinum-Based Chemotherapy in Recurrent EGFR/ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
Published date:
08/18/2021
Excerpt:
Patients with recurrent EGFR-mutated or ALK-rearranged NSCLC, previously treated with targeted therapy, were eligible. Patients were treated with carboplatin AUC5, pemetrexed 500 mg/m2 and pembrolizumab 200 mg I.V. every 3 weeks. After 4 cycles patients were maintained on pemetrexed and pembrolizumab for up to 2 years....Response rates (95%CI) were 42% (23%, 63%) and 29% (4%, 71%) among EGFR+ and ALK+ patients, respectively. Median duration of response was 6.1 months in all patients and in EGFR+ patients.
Secondary therapy:
carboplatin + pemetrexed
Source:
Title:
OA09.03 - Pembrolizumab in Combination With Platinum-Based Chemotherapy in Recurrent EGFR/ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
Published date:
08/18/2021
Excerpt:
Patients with recurrent EGFR-mutated or ALK-rearranged NSCLC, previously treated with targeted therapy, were eligible. Patients were treated with carboplatin AUC5, pemetrexed 500 mg/m2 and pembrolizumab 200 mg I.V. every 3 weeks….Pembrolizumab in combination with chemotherapy demonstrated a response rate of 42% and median survival of 22 months among patients with recurrent EGFR-mutated NSCLC.
Secondary therapy:
carboplatin + pemetrexed
Source:
Title:
Pembrolizumab Plus Chemotherapy or Anlotinib vs. Pembrolizumab Alone in Patients With Previously Treated EGFR-Mutant NSCLC
Published date:
04/16/2021
Excerpt:
In this retrospective analysis, we compared the clinical efficacy of pembrolizumab monotherapy (PM), pembrolizumab combined with chemotherapy (P+C) and pembrolizumab combined with anlotinib (P+A) in NSCLC patients with EGFR mutation who had failed on EGFR-TKI and platinum-based chemotherapy....The addition of chemotherapy or antiangiogenic therapy to pembrolizumab resulted in significantly longer PFS, OS and ORR than pembrolizumab alone in our study.
Secondary therapy:
SRPK1 inhibitor therapeutic; Chemotherapy
DOI:
10.3389/fonc.2021.671228
Source:
Title:
Real-world outcomes of anti-PD1 antibodies in platinum-refractory, PD-L1-positive recurrent and/or metastatic non-small cell lung cancer, and its potential practical predictors: first report from Korean Cancer Study Group LU19-05
Published date:
02/01/2021
Excerpt:
R/M-NSCLC treated with pembrolizumab or nivolumab...In multivariable analysis, concordance of TPS ≥ 50% in both PD-L1 assays and the development of immune-related adverse events (irAEs) were two significant predictors of better ORR, PFS, and OS. EGFR mutation could also predict significantly worse OS outcomes.
DOI:
10.1007/s00432-021-03527-4
Source:
Title:
Efficacy of Immune Checkpoint Inhibitor Monotherapy for Advanced Non-Small-Cell Lung Cancer with ALK Rearrangement
Published date:
04/15/2020
Excerpt:
We genotyped 190 patients with advanced lung adenocarcinomas who received nivolumab or pembrolizumab monotherapy...The progression-free survival was 0.6 (95% CI: 0.2-2.1) months for ALK-positive patients and 1.8 (95% CI: 1.2-2.1) months for EGFR-positive patients... Our data suggested that ICI treatment was significantly less efficacious in patients with ALK rearrangement than in patients with EGFR mutations...
DOI:
10.3390/ijms21072623
Source:
Title:
Efficacy and Safety of Pembrolizumab Plus Docetaxel vs Docetaxel Alone in Patients With Previously Treated Advanced Non–Small Cell Lung Cancer The PROLUNG Phase 2 Randomized Clinical Trial
Published date:
04/09/2020
Excerpt:
In this phase 2 study, the combination of pembrolizumab plus docetaxel was well tolerated and substantially improved ORR and PFS in patients with advanced NSCLC who had previous progression after platinum-based chemotherapy, including NSCLC with EGFR variations.
Secondary therapy:
docetaxel
DOI:
10.1001/jamaoncol.2020.0409
Trial ID:
Source:
Title:
PD-L1 expression and response to pembrolizumab in patients with EGFR-mutant non-small cell lung cancer
Published date:
03/27/2020
Excerpt:
The objective response rate to pembrolizumab of 14 patients was 36%, including 22% in patients with common EGFR mutations,
DOI:
10.1093/jjco/hyaa033
