A Phase I/II Study of Carboplatin/Nab-Paclitaxel and MK-3475 for Advanced Non-Small Cell Lung Cancer (NSCLC): HCRN LUN13-175

This is a phase I/II study for previously untreated patients with advanced NSCLC. The study will take place in two phases. First, a cohort of twelve participants will be enrolled in phase I and will be treated with carboplatin, nab-paclitaxel and MK-3475 and evaluated for safety and tolerability after 2 cycles of therapy. If needed, a second cohort of twelve participants will be enrolled. Following successful completion of the dose-finding/safety run-in cohort, the study will proceed to phase II.

Mandatory pre-treatment tumor biopsies will be obtained prior to initiating treatment for all participants (only if adequate archived samples are unavailable). Mandatory tumor biopsies will be obtained in the phase II part of the study after 4 cycles or at the time of progression, whichever comes first.

The phase II part of the study is a single arm study. All participants will be treated with carboplatin, nab-paclitaxel, and MK-3475 at the recommended phase II dose (RP2D) in 21-day cycles for up to 4 cycles. Participants will be evaluated for response every 2 cycles (6 weeks).

For participants without progression of disease after Cycle 4, MK-3475 will continue every 3 weeks for up to 2 years or until unacceptable toxicity.

• Condition: Non-Small Cell Lung Cancer
• Intervention:
  • Drug: Carboplatin
  • Drug: Nab-paclitaxel
  • Drug: Pembrolizumab
• Phase: Phase 1/2

For full description, see www.clinicaltrials.gov.

Abstracts/Posters/Presentations:

• R. Gentzler, N. Mohindra, S. Jalal, K. Reckamp, R. Hall, N. Hanna, Y.K. Chae, V. Villaflor, M. Koczywas, I. Helenowski, A. Rademaker, J. Patel. Ph I/II Carboplatin, Nab-Paclitaxel and Pembrolizumab for Advanced NSCLC (HCRN LUN13-175): Outcomes by Nab-Paclitaxel Dose. Presented at the IASLC 2019 World Conference on Lung Cancer. See abstract.