A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of INCMGA00012, an Anti-PD-1 Antibody, in Combination With Chemoradiation in Participants With Unresectable, Stage III Non-Small Cell Lung Cancer (POD1UM-301)
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- Incyte Corporation
- Primary Endpoint
- Progression-free survival (PFS)
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Eastern Cooperative Oncology Group performance status 0 to
- •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.
Arms & Interventions
Chemoradiation therapy + INCMGA00012
Intervention: Retifanlimab (Drug)
Chemoradiation therapy + INCMGA00012
Intervention: Pemetrexed (Drug)
Chemoradiation therapy + INCMGA00012
Intervention: Cisplatin (Drug)
Chemoradiation therapy + INCMGA00012
Intervention: Carboplatin (Drug)
Chemoradiation therapy + INCMGA00012
Intervention: Paclitaxel (Drug)
Chemoradiation therapy + INCMGA00012
Intervention: Etoposide (Drug)
Chemoradiation therapy + INCMGA00012
Intervention: Radiotherapy (Radiation)
Chemoradiation therapy + Placebo
Intervention: Placebo (Drug)
Chemoradiation therapy + Placebo
Intervention: Pemetrexed (Drug)
Chemoradiation therapy + Placebo
Intervention: Cisplatin (Drug)
Chemoradiation therapy + Placebo
Intervention: Carboplatin (Drug)
Chemoradiation therapy + Placebo
Intervention: Paclitaxel (Drug)
Chemoradiation therapy + Placebo
Intervention: Etoposide (Drug)
Chemoradiation therapy + Placebo
Intervention: Radiotherapy (Radiation)
Outcomes
Primary Outcomes
Progression-free survival (PFS)
Time Frame: Up to approximately 3 years.
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.
Secondary Outcomes
- Overall survival (OS)(Up to approximately 3 years.)
- Number of treatment-emergent adverse events(Up to approximately 3 years.)
- Objective response rate (ORR)(Up to approximately 3 years.)
- Duration of response (DOR)(Up to approximately 3 years.)
- AUC0-t of INCMGA00012.(Cycle 1 Day 1, Cycle 2 Day 1 and Consolidation Cycle 1 Day 1, Cycle 4 Day 1, Cycle 8 Day 1, and Cycle 12 Day 1, up to approximately 18 months.)
- tmax of INCMGA00012.(Cycle 1 Day 1, Cycle 2 Day 1 and Consolidation Cycle 1 Day 1, Cycle 4 Day 1, Cycle 8 Day 1, and Cycle 12 Day 1, up to approximately 18 months.)
- Cmin of INCMGA00012.(Cycle 1 Day 1, Cycle 2 Day 1 and Consolidation Cycle 1 Day 1, Cycle 4 Day 1, Cycle 8 Day 1, and Cycle 12 Day 1, up to approximately 18 months.)
- Cmax of INCMGA00012.(Cycle 1 Day 1, Cycle 2 Day 1 and Consolidation Cycle 1 Day 1, Cycle 4 Day 1, Cycle 8 Day 1, and Cycle 12 Day 1, up to approximately 18 months.)