Proof-of-Concept Trial of Chemotherapy Plus Immune Checkpoint Inhibitor in Unresectable NSCLC
Posted: Monday, August 16, 2021
A one-arm, open-label, proof-of-concept phase I/II trial, published in Cancer Treatment and Research Communications, was conducted to evaluate the safety and efficacy of nab-paclitaxel plus pembrolizumab in patients with unresectable stage III or IV non–small cell lung cancer (NSCLC). Although this study could not be completed because of administrative delays and changing patterns of practice, Normand Blais, MD, MSc, of the Université de Montréal, Canada, and colleagues explained that these agents may be safely combined.
“One long-term responder was observed out of four treated patients,” the investigators commented. “Other groups have shown that many different dose schedules of this combination can be useful in different clinical settings.”
The objective of the phase I portion of the trial was to determine the recommended phase II dose of nab-paclitaxel using a traditional 3+3 dose-escalation scheme. Between 2015 and 2017, just four patients were enrolled.
Three patients underwent treatment at the first dose level; when administered on days 1 and 8, 100 mg/m2 of nab-paclitaxel was found to be tolerated. One patient underwent treatment at the second dose level; she was administered 100 mg/m2 of nab-paclitaxel on days 1, 8, and 15 of every 21-day cycle. After three cycles of therapy, the dose of day 15 was cancelled due to the onset of grade 3 fatigue. The patient underwent chemotherapy for a total of 8 cycles, but pembrolizumab was administered for 20 additional cycles; due to the onset of grade 3 polyarthritis, pembrolizumab was discontinued. More than 38 months after the initiation of therapy, she remained in partial response.
“Administrative delays in the approval of the project and contract as well as the rapidly changing patterns of practice forced the early closure of this trial,” the investigators remarked.
Disclosure: For full disclosures of the study authors, visit sciencedirect.com.