Carboplatin/Nab-Paclitaxel and Pembrolizumab in NSCLC
Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
This is a phase I/II study for previously untreated subjects with advanced NSCLC. The study
will take place in two phases. First, a cohort of twelve participants will be enrolled in
phase I part and will be treated with carboplatin, nab-paclitaxel and pembrolizumab. A cohort
of twelve subjects will be evaluated for safety and tolerability after 2 cycles of therapy.
All subjects who receive either nab-paclitaxel or pembrolizumab will be evaluable. If 33% of
subjects or less have unacceptable toxicity in the first cohort or any subsequent cohort (if
necessary), the study will proceed to the Phase II part. If more than 33% have unacceptable
toxicity, 12 additional subjects will be enrolled in a second cohort, if necessary. If
unacceptable toxicity is seen in more than 33% in Cohort 2, the study will end due to
unacceptable toxicity of this drug combination.
The phase II part of the study is a single arm study. All subjects will be treated with
carboplatin, nab-paclitaxel, and pembrolizumab in 21-day cycles for up to 4 cycles.
Mandatory pre-treatment tumor biopsies will be obtained prior to initiating treatment for all
subjects (only if adequate archived samples are unavailable). Mandatory tumor biopsies will
be obtained in the Phase II part of the study after 4 cycles of study treatment or at the
time of progression, whichever comes first.
For subjects without progression of disease after Cycle 4, pembrolizumab will continue every
3 weeks for up to 2 years or until unacceptable toxicity.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Nisha Mohindra, MD
Collaborators:
Celgene Corporation Hoosier Cancer Research Network Merck Sharp & Dohme Corp.