Back to resultsINCMGA00012 in Combination With Chemoradiation in Participants With Stage III Non-Small Cell Lung Cancer (POD1UM-301)
Primary Purpose
Non-small Cell Lung Cancer
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Retifanlimab
Placebo
Pemetrexed
Cisplatin
Carboplatin
Paclitaxel
Etoposide
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Non-small cell lung cancer, unresectable, Stage III, PD-1, PD-L1
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Chemoradiation therapy + INCMGA00012
Chemoradiation therapy + Placebo
Arm Description
Outcomes
Primary Outcome Measures
Progression-free survival (PFS)
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
Overall survival (OS)
Defined as the time from randomization until death due to any cause.
Objective response rate (ORR)
Defined as the percentage of participants having a complete response or partial response per RECIST v1.1 based on BICR.
Duration of response (DOR)
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.
Number of treatment-emergent adverse events
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Cmax of INCMGA00012.
Maximum observed plasma or serum concentration.
tmax of INCMGA00012.
Time to maximum concentration.
Cmin of INCMGA00012.
Minimum observed plasma or serum concentration over the dose interval.
AUC0-t of INCMGA00012.
Area under the plasma or serum concentration curve.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04203511
Brief Title
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
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor Strategic/Business Decision
Study Start Date
July 31, 2020 (Anticipated)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Non-small cell lung cancer, unresectable, Stage III, PD-1, PD-L1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chemoradiation therapy + INCMGA00012
Arm Type
Experimental
Arm Title
Chemoradiation therapy + Placebo
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Retifanlimab
Other Intervention Name(s)
INCMGA00012
Intervention Description
INCMGA00012 administered intravenously every 3 weeks on Day 1 of each 21-day cycle for 4 cycles, followed by a consolidation part of INCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to12 cycles.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered intravenously every 3 weeks on Day 1 of each 21-day cycle for 4 cycles, followed by a consolidation part of placebo administered intravenously on Day 1 of each 28-day cycle for up to 12 cycles.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Pemetrexed administered intravenously every 3 weeks on Day 1 of each cycle with either carboplatin or cisplatin (nonsquamous NSCLC only) for 2 cycles (if radiation therapy is started on Cycle 1 Day 1) or 3 cycles (if radiation therapy is started after Cycle 1).
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin administered intravenously every 3 weeks on Day 1 of each cycle with either etoposide or pemetrexed (nonsquamous NSCLC only) for 2 cycles (if radiation therapy is started on Cycle 1 Day 1) or 3 cycles (if radiation therapy is started after Cycle 1).
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin administered intravenously every 3 weeks on Day 1 of each cycle with either pemetrexed (nonsquamous NSCLC only) or paclitaxel for 2 cycles (if radiation therapy is started on Cycle 1 Day 1) or 3 cycles (if radiation therapy is started after Cycle 1).
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel administered intravenously every 3 weeks on Days 1, 8, and 15 of each cycle with carboplatin for 2 cycles (if radiation therapy is started on Cycle 1 Day 1) or 3 cycles (if radiation therapy is started after Cycle 1).
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
Etoposide administered intravenously every 3 weeks on Days 1-3 of each cycle with cisplatin for 2 cycles (if radiation therapy is started on Cycle 1 Day 1) or 3 cycles (if radiation therapy is started after Cycle 1).
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Total dose of 60 Gy ± 10% (54 to 66 Gy) in 2 Gy daily fractions.
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
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.
Time Frame
Up to approximately 3 years.
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
Defined as the time from randomization until death due to any cause.
Time Frame
Up to approximately 3 years.
Title
Objective response rate (ORR)
Description
Defined as the percentage of participants having a complete response or partial response per RECIST v1.1 based on BICR.
Time Frame
Up to approximately 3 years.
Title
Duration of response (DOR)
Description
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.
Time Frame
Up to approximately 3 years.
Title
Number of treatment-emergent adverse events
Description
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Time Frame
Up to approximately 3 years.
Title
Cmax of INCMGA00012.
Description
Maximum observed plasma or serum concentration.
Time Frame
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.
Title
tmax of INCMGA00012.
Description
Time to maximum concentration.
Time Frame
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.
Title
Cmin of INCMGA00012.
Description
Minimum observed plasma or serum concentration over the dose interval.
Time Frame
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.
Title
AUC0-t of INCMGA00012.
Description
Area under the plasma or serum concentration curve.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Incyte Medical Monitor
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
INCMGA00012 in Combination With Chemoradiation in Participants With Stage III Non-Small Cell Lung Cancer (POD1UM-301)
We'll reach out to this number within 24 hrs