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

NCT04203511 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: INCMGA 0012-301
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancer; unresectable; Stage III; PD-1; PD-L1

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to approximately 3 years.

Secondary Outcomes (8)

• Overall survival (OS)

  Up to approximately 3 years.

• Objective response rate (ORR)

  Up to approximately 3 years.

• Duration of response (DOR)

  Up to approximately 3 years.

• Number of treatment-emergent adverse events

  Up to approximately 3 years.

• 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.

Study Arms (2)

Chemoradiation therapy + INCMGA00012

EXPERIMENTAL

Drug: Retifanlimab; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel; Drug: Etoposide; Radiation: Radiotherapy

Chemoradiation therapy + Placebo

ACTIVE COMPARATOR

Drug: Placebo; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel; Drug: Etoposide; Radiation: Radiotherapy

Interventions

Retifanlimab DRUG

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.

Also known as: INCMGA00012

Chemoradiation therapy + INCMGA00012

Placebo DRUG

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.

Chemoradiation therapy + Placebo

Pemetrexed DRUG

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).

Chemoradiation therapy + INCMGA00012; Chemoradiation therapy + Placebo

Cisplatin DRUG

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).

Chemoradiation therapy + INCMGA00012; Chemoradiation therapy + Placebo

Carboplatin DRUG

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).

Chemoradiation therapy + INCMGA00012; Chemoradiation therapy + Placebo

Paclitaxel DRUG

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).

Chemoradiation therapy + INCMGA00012; Chemoradiation therapy + Placebo

Etoposide DRUG

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).

Chemoradiation therapy + INCMGA00012; Chemoradiation therapy + Placebo

Radiotherapy RADIATION

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

Chemoradiation therapy + INCMGA00012; Chemoradiation therapy + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Cisplatin; Carboplatin; Paclitaxel; Etoposide; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Therapeutics

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 18, 2019
• Study Start: July 31, 2020
• Primary Completion: November 30, 2023
• Study Completion: January 31, 2025
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share