INCMGA00012 in Combination With Chemoradiation in Participants With Stage III Non-Small Cell Lung Cancer (POD1UM-301)

Phase 3WithdrawnNCT04203511

Incyte Corporation

Overview

The purpose of this study is to assess the efficacy and safety of INCMGA00012 in combination with chemoradiation therapy (CRT) in participants with unresectable, Stage III non-small cell lung cancer (NSCLC). The study will randomize approximately 360 participants in a 2:1 ratio into the INCMGA00012 in combination with CRT followed by consolidation therapy with INCMGA00012 treatment group and placebo in combination with CRT followed by consolidation therapy with placebo treatment group.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Non-small Cell Lung Cancer

Interventions

RetifanlimabDRUG

INCMGA00012 administered intravenously every 3 weeks on Day 1 of each 21-day cycle for 4 cycles, followed by a consolidation part of INCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to12 cycles.

PlaceboDRUG

Placebo administered intravenously every 3 weeks on Day 1 of each 21-day cycle for 4 cycles, followed by a consolidation part of placebo administered intravenously on Day 1 of each 28-day cycle for up to 12 cycles.

PemetrexedDRUG

Pemetrexed administered intravenously every 3 weeks on Day 1 of each cycle with either carboplatin or cisplatin (nonsquamous NSCLC only) for 2 cycles (if radiation therapy is started on Cycle 1 Day 1) or 3 cycles (if radiation therapy is started after Cycle 1).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically or cytologically confirmed NSCLC that is locally advanced and unresectable. * Adequate tumor sample from fresh biopsy or archival tissue block must be available. * Evaluable disease per RECIST v1.1. * Eastern Cooperative Oncology Group performance status 0 to 1. * Willingness to avoid pregnancy or fathering children. Exclusion Criteria: * Receipt of cancer treatment for this malignancy, including but not limited to radiation therapy, investigational agents, chemotherapy, and immunotherapy for disease under consideration. * Recent major surgery within 4 weeks before entry into the study. * Any medical contraindication to platinum-based doublet chemotherapy. * Active autoimmune disease requiring systemic immunosuppression in excess of physiologic consolidation doses of corticosteroids (\> 10 mg/day of prednisone or equivalent). * Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (eg, antihistamines and corticosteroids). * Mixed small cell and NSCLC histology. * Evidence of interstitial lung disease or active noninfectious pneumonitis. * Participants who are HIV-positive. * History of organ transplant, including allogeneic stem cell transplantation.

Outcomes

Primary Outcomes

Progression-free survival (PFS)

Defined as the time from randomization until disease progression, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by blinded independent central review (BICR), or death due to any cause.