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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04203511
Recruitment Status : Withdrawn (Sponsor Strategic/Business Decision)
First Posted : December 18, 2019
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Retifanlimab Drug: Placebo Drug: Pemetrexed Drug: Cisplatin Drug: Carboplatin Drug: Paclitaxel Drug: Etoposide Radiation: Radiotherapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Estimated Study Start Date : July 31, 2020
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : January 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chemoradiation therapy + INCMGA00012 Drug: Retifanlimab
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.
Other Name: INCMGA00012

Drug: Pemetrexed
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).

Drug: Cisplatin
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).

Drug: Carboplatin
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).

Drug: Paclitaxel
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).

Drug: Etoposide
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).

Radiation: Radiotherapy
Total dose of 60 Gy ± 10% (54 to 66 Gy) in 2 Gy daily fractions.

Active Comparator: Chemoradiation therapy + Placebo Drug: Placebo
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.

Drug: Pemetrexed
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).

Drug: Cisplatin
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).

Drug: Carboplatin
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).

Drug: Paclitaxel
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).

Drug: Etoposide
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).

Radiation: Radiotherapy
Total dose of 60 Gy ± 10% (54 to 66 Gy) in 2 Gy daily fractions.




Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 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 :
  1. Overall survival (OS) [ Time Frame: Up to approximately 3 years. ]
    Defined as the time from randomization until death due to any cause.

  2. Objective response rate (ORR) [ Time Frame: 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.

  3. Duration of response (DOR) [ Time Frame: 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.

  4. Number of treatment-emergent adverse events [ Time Frame: 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.

  5. Cmax of INCMGA00012. [ 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. ]
    Maximum observed plasma or serum concentration.

  6. tmax of INCMGA00012. [ 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. ]
    Time to maximum concentration.

  7. Cmin of INCMGA00012. [ 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. ]
    Minimum observed plasma or serum concentration over the dose interval.

  8. AUC0-t of INCMGA00012. [ 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. ]
    Area under the plasma or serum concentration curve.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04203511


Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Incyte Medical Monitor Incyte Corporation
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT04203511    
Other Study ID Numbers: INCMGA 0012-301
First Posted: December 18, 2019    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Non-small cell lung cancer
unresectable
Stage III
PD-1
PD-L1
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Etoposide
Carboplatin
Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors