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Report for Clinical Trial NCT03242915

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase II Multi-center Study of Pembrolizumab in Combination With Platinum-based Doublet Chemotherapy in Patients With EGFR Mutation and ALK Positive NSCLC (Non-Small Cell Lung Cancer) With Progressive Disease Following Prior Tyrosine Kinase Inhibitors (TKIs)

Investigators hypothesize that addition of pembrolizumab will enhance the efficacy of carboplatin and pemetrexed in EGFR (epidermal growth factor receptor) mutation and ALK (anaplastic lymphoma kinase) positive NSCLC patients who have disease progression following prior TKIs (tyrosine kinase inhibitors).

NCT03242915 Non-small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung Disease Progression
HPO:Neoplasm of the lung Non-small cell lung carcinoma

3 Interventions

Name: Pembrolizumab

Description: 200mg IV every 3 weeks
Type: Drug
Group Labels: 1

Pembrolizumab/Carboplatin/Pemetrexed

Name: Carboplatin

Description: AUC 5 IV every 3 weeks
Type: Drug
Group Labels: 1

Pembrolizumab/Carboplatin/Pemetrexed

Name: Pemetrexed

Description: 500 mg/m^2 IV every 3 weeks
Type: Drug
Group Labels: 1

Pembrolizumab/Carboplatin/Pemetrexed


Primary Outcomes

Description: The primary endpoint is Response Rate (RR) defined as the rate of complete and partial response. Complete Response (CR): Disappearance of all non-target lesions. All lymph nodes must be non-pathological in size (<10mm short axis). Partial Response (PR): Persistence of one or more non-target lesion(s) but does not qualify for PD. Progressive Disease (PD): Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered progression).

Measure: The number of patients that respond to treatment

Time: 12 months

Secondary Outcomes

Description: PFS is defined as the duration of time from registration to time of progression. Progressive Disease (PD): Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered progression).

Measure: Progression free survival (PFS) time

Time: 12 months

Description: Overall survival is defined as the time from registration to time of death. If the patient is lost to follow-up, survival will be censored on the last date the patient was known to be alive.

Measure: Overall survival (OS) time

Time: 12 months

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There are 2 SNPs

SNPs


1 L858R

If the patient is lost to follow-up, survival will be censored on the last date the patient was known to be alive.. Inclusion Criteria: - Exon 19 deletion or Exon 21 L858R or L861Q or exon 18 G719X or S7681 EGFR mutation positive NSCLC patients, or ALK rearranged NSCLC patients previously treated with a tyrosine kinase inhibitor with progressive and measurable disease. --- L858R ---

Inclusion Criteria: - Exon 19 deletion or Exon 21 L858R or L861Q or exon 18 G719X or S7681 EGFR mutation positive NSCLC patients, or ALK rearranged NSCLC patients previously treated with a tyrosine kinase inhibitor with progressive and measurable disease. --- L858R ---


2 L861Q

If the patient is lost to follow-up, survival will be censored on the last date the patient was known to be alive.. Inclusion Criteria: - Exon 19 deletion or Exon 21 L858R or L861Q or exon 18 G719X or S7681 EGFR mutation positive NSCLC patients, or ALK rearranged NSCLC patients previously treated with a tyrosine kinase inhibitor with progressive and measurable disease. --- L858R --- --- L861Q ---

Inclusion Criteria: - Exon 19 deletion or Exon 21 L858R or L861Q or exon 18 G719X or S7681 EGFR mutation positive NSCLC patients, or ALK rearranged NSCLC patients previously treated with a tyrosine kinase inhibitor with progressive and measurable disease. --- L858R --- --- L861Q ---



HPO Nodes


HPO: