Non Small Cell Lung Cancer

Platinum-Based Chemotherapy With/Without INCMGA00012, an anti-PD-1 antibody, in Non–Small Cell Lung Cancer

Incyte Study ID:
INCMGA 0012-304
CT.gov ID:
NCT04205812
Eudra ID:
2019-003372-39
EU CT Number:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Recruitment Complete
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Results Available

Protocol
Available Languages: English
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Statistical Analysis Plan (SAP)
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Clinical Study Purpose

The purpose of this study is to assess the efficacy and safety of platinum-based chemotherapy with or without INCMGA00012 in participants with metastatic squamous and nonsquamous non–small cell lung cancer (NSCLC).

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: nab-Paclitaxel
    • COLLABORATORS
    N/A
    DATE
    Sep 2020 - Aug 2026
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    INNOVATIVE CLINICAL RESEARCH INSTITUTE
    WHITTIER, CA, US, 90603
    Name
    READING HOSPITAL AND MEDICAL CENTER
    READING, PA, US, 19612
    Name
    SHANGHAI CHEST HOSPITAL
    SHANGHAI, China, 200030
    Name
    LINYI CANCER HOSPITAL
    LINYI, China, 276001
    Name
    HENAN PROVINCIAL PEOPLES HOSPITAL
    ZHENGZHOU, China, 450003
    Name
    NEMOCNICE AGEL OSTRAVA - VITKOVICE A.S
    OSTRAVA - VITKOVICE, Czech Republic, 703 84
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    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Histologically or cytologically confirmed NSCLC (either nonsquamous or squamous) that is Stage IV (AJCC v8).
    • No prior systemic treatment for the advanced/metastatic NSCLC

    Exclusion Criteria

    • Clinically significant cardiac disease within 6 months of start of study treatment.
    • Any major surgery within 3 weeks of the first dose of study treatment.

    Protocol Summary

    Incyte Study ID:
    INCMGA 0012-304
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Double (Participant, Investigator)
    Interventions:
  • Drug: Retifanlimab
  • Drug: Placebo
  • Drug: Pemetrexed
  • Drug: Cisplatin
  • Drug: Carboplatin
  • Drug: Paclitaxel
  • Drug: nab-Paclitaxel
    • Enrollment:
    583
    Primary Outcome
    Open

    Overall survival (OS)

    Timeframe: Approximately 4.5 years.

    Secondary Outcome
    Open

    Progression-free survival (PFS)

    Timeframe: Approximately 4.5 years

    Objective response rate (ORR)

    Timeframe: Approximately 4.5 years.

    Duration of response (DOR)

    Timeframe: Approximately 4.5 years.

    Number of treatment-emergent adverse events

    Timeframe: Approximately 4.5 years.

    Cmax of INCMGA00012 when administered with chemotherapy

    Timeframe: Approximately 4.5 years.

    AUC of INCMGA00012 when administered with chemotherapy

    Timeframe: Up to approximately 4.5 years.