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

Phase 3

Withdrawn

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Retifanlimab; Drug: Placebo; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel; Drug: Etoposide; Radiation: Radiotherapy

• Registration Number: NCT04203511
• Lead Sponsor: Incyte Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-18
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-05
• Last Update Posted: 2020-06-09
• Study Start: 2020-07-31
• Primary Completion: 2023-11-30
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemoradiation therapy + INCMGA00012	Etoposide	-
Chemoradiation therapy + INCMGA00012	Cisplatin	-
Chemoradiation therapy + INCMGA00012	Paclitaxel	-
Chemoradiation therapy + INCMGA00012	Retifanlimab	-
Chemoradiation therapy + Placebo	Carboplatin	-
Chemoradiation therapy + INCMGA00012	Carboplatin	-
Chemoradiation therapy + INCMGA00012	Radiotherapy	-
Chemoradiation therapy + Placebo	Placebo	-
Chemoradiation therapy + Placebo	Paclitaxel	-
Chemoradiation therapy + Placebo	Radiotherapy	-
Chemoradiation therapy + INCMGA00012	Pemetrexed	-
Chemoradiation therapy + Placebo	Pemetrexed	-
Chemoradiation therapy + Placebo	Cisplatin	-
Chemoradiation therapy + Placebo	Etoposide	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	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 Outcome Measures

Name	Time	Method
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.	Time to maximum concentration.
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.	Minimum observed plasma or serum concentration over the dose interval.
Overall survival (OS)	Up to approximately 3 years.	Defined as the time from randomization until death due to any cause.
Number of treatment-emergent adverse events	Up to approximately 3 years.	Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Objective response rate (ORR)	Up to approximately 3 years.	Defined as the percentage of participants having a complete response or partial response per RECIST v1.1 based on BICR.
Duration of response (DOR)	Up to approximately 3 years.	Defined as the time from the first documented response (complete response or partial response) according to RECIST v1.1 until disease progression or death due to any cause.
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.	Area under the plasma or serum concentration curve.
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.	Maximum observed plasma or serum concentration.