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

• Status: Withdrawn
• Trial end date: 2025-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Etoposide; Etoposide phosphate; Paclitaxel; Pemetrexed

Criteria

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.