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).
Name: Pembrolizumab
Name: Carboplatin
Name: Pemetrexed
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 monthsDescription: 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 monthsDescription: 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 monthsAllocation: N/A
Single Group Assignment
There are 2 SNPs
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 ---
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 ---