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

Incyte

Status and phase: Withdrawn; Phase 3

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Cisplatin; Drug: Etoposide; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Carboplatin; Drug: Retifanlimab; Drug: Placebo; Radiation: Radiotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04203511

INCMGA 0012-301

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 2 patient groups

Chemoradiation therapy + INCMGA00012

Experimental group

Treatment:

Radiation: Radiotherapy

Drug: Retifanlimab

Drug: Carboplatin

Drug: Paclitaxel

Drug: Pemetrexed

Drug: Etoposide

Drug: Cisplatin

Chemoradiation therapy + Placebo

Active Comparator group

Treatment:

Radiation: Radiotherapy

Drug: Placebo

Drug: Carboplatin

Drug: Paclitaxel

Drug: Pemetrexed

Drug: Etoposide

Drug: Cisplatin