NCT02733250

Pembrolizumab With Nab-Paclitaxel in Non-Small Cell Lung Cancer

A Phase I/II Study of Pembrolizumab in Combination With Nab-Paclitaxel in Patients With Unresectable Stage III or Stage IV Non-Small Cell Lung Carcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the optimal dose of nab-paclitaxel to be safely administered in combination with pembrolizumab in patients with advanced inoperable non-small cell lung cancer. The study is also aimed at evaluating the efficacy of the combination therapy.

Detailed description

This is a phase 1/2, open-label, proof of concept study of nab-paclitaxel administered in combination with pembrolizumab in patients with advanced non-small cell lung cancer (NSCLC). Part 1 of the study will assess the dose limiting toxicity (DLT) of nab-paclitaxel in combination with a fixed dose of pembrolizumab (200 mg administered on day 1 of each 21 day cycle). Dose escalation for nab-paclitaxel will be conducted according to the "3+3 design" until the recommended phase 2 dose (RP2D) is determined. Part 2 of the study will evaluate the administration of pembrolizumab at a dose of 200 mg every 3 weeks in combination with nab-paclitaxel at the RP2D. Determining the RP2D will classify the treatment combination as safe and allow for an expansion of the study population, which will ultimately lead to further assessments of safety and tolerability as well as an evaluation of the anti-tumoral effect of the proposed treatment combination. Using Simon's optimal 2-stage design for Phase II clinical trials, we determined that a sample size of 36 patients would be adequate to test the proposed hypothesis. The primary efficacy analysis of overall response rate (ORR) will be interpreted as follows: 1) if less than 9 partial response (PR) or complete response (CR) are recorded, the combination of nab-paclitaxel and pembrolizumab provides less than additive effects and is not likely to be clinically superior compared to pembrolizumab alone based on an ORR assessment; 2) however, if 9 or more PR or CR are recorded, the treatment combination warrants further clinical study. This could take the form of an extended phase II (to reach the 97 patients calculated from the model) or a phase III study. Treatment will continue until disease progression (as per RECIST 1.1), unacceptable adverse event(s), intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the subject, investigator's noncompliance with trial treatment or procedures requirements, the subject receives 24 months of uninterrupted treatment or 35 administrations of study medication (whichever is later), or administrative reasons.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	200mg IV Day 1 of each 21 cycles
DRUG	Nab-Paclitaxel	100mg/m2 IV Day 1, 8 and 15 of every 21 day cycles

Timeline

• Start date: 2017-03-13
• Primary completion: 2019-04-13
• Completion: 2019-12-13
• First posted: 2016-04-11
• Last updated: 2021-02-16

Locations

2 sites across 1 country: Canada