FAICIC Clinical Research | Veracruz, Mexico
Status and phase
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About
The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs. pembrolizumab plus maintenance olaparib placebo for the treatment of squamous NSCLC. The study's 2 primary hypotheses are:
As of Amendment 07, there will be no further analyses for OS and patient-reported outcome assessments.
Full description
This study has 2 phases: an Induction Phase (4 Cycles) and a Maintenance Phase (Up to 31 cycles of pembrolizumab). In the Induction Phase, participants receive pembrolizumab plus carboplatin plus a taxane (paclitaxel or nab-paclitaxel). In the Maintenance Phase, participants with a partial or complete disease response or with stable disease after completing four cycles of induction therapy and who meet eligibility criteria will be randomly assigned to receive pembrolizumab plus maintenance olaparib OR pembrolizumab plus maintenance olaparib placebo. In the Maintenance Phase, participants randomly assigned to receive pembrolizumab for up to 31 cycles plus maintenance olaparib OR maintenance olaparib placebo until centrally verified progressive disease (PD), intolerable toxicities, or physician decision.
As of Amendment 07, participants actively taking placebo will discontinue taking the placebo intervention and continue in the study.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Have a histologically or cytologically confirmed diagnosis squamous NSCLC.
Have Stage IV squamous NSCLC.
Have measurable disease based on RECIST 1.1.
Have not received prior systemic treatment for their advanced/metastatic NSCLC.
Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated.
Note: Adequacy of biopsy specimen for the above analyses must be confirmed by the central laboratory before the participant can receive study intervention(s). Submission of another tumor specimen may be required prior to enrolling the participant, if adequate tumor tissue was not provided the first time.
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention
Have a life expectancy of at least 3 months.
Has adequate organ function.
Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for 180 days afterwards.
Male participants must refrain from donating sperm during the treatment period and for 180 days afterwards.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
591 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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