Clinical trial NCT04203511: INCMGA00012 in Combination With Chemoradiation in Participants With Stage III Non-Small Cell Lung Cancer (POD1UM-301)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Keywords: Non-small cell lung cancer
unresectable
Stage III
PD-1
PD-L1
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2019-12-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to approximately 3 years.
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up to approximately 3 years.
measure: Objective response rate (ORR)
timeFrame: Up to approximately 3 years.
measure: Duration of response (DOR)
timeFrame: Up to approximately 3 years.
measure: Number of treatment-emergent adverse events
timeFrame: Up to approximately 3 years.
measure: Cmax of INCMGA00012.
timeFrame: 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.
measure: tmax of INCMGA00012.
timeFrame: 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.
measure: Cmin of INCMGA00012.
timeFrame: 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.
measure: AUC0-t of INCMGA00012.
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: Incyte Corporation
name: Incyte Medical Monitor
role: STUDY_DIRECTOR
References: