Non Small Cell Lung Cancer

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

Incyte Study ID:

INCMGA 0012-301

CT.gov ID:

NCT04203511

Eudra ID:

N/A

Sponsor:

Incyte Corporation

Collaborator:

N/A

Study Contact Information:

1.855.463.3463 or [email protected]

Other

Subscribe to Updates Contact Us

Clinical Study Purpose

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.

Clinical Study Summary

MEDICAL CONDITION(S)

Non Small Cell Lung Cancer

PRODUCT

Drug: Retifanlimab

Drug: Placebo

Drug: Pemetrexed

Drug: Cisplatin

Drug: Carboplatin

Drug: Paclitaxel

Drug: Etoposide

COLLABORATORS

N/A

DATE

Jul 2020 - Nov 2023

TYPE

Interventional

PHASE

Phase 3

SEX

Female & Male

AGE

18+ years

ACCEPTS HEALTHY VOLUNTEERS

Clinical Study Locations

No locations found.

Key Inclusion and Exclusion 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.

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.

Protocol Summary

Incyte Study ID:

INCMGA 0012-301

Primary Purpose:

Treatment

Allocation:

Randomized

Study Design:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Interventions:

Drug

Enrollment:

Primary Outcome

Open