Clinical Trials /

Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer

NCT04205812

Description:

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).

Related Conditions:
  • Non-Squamous Non-Small Cell Lung Carcinoma
  • Squamous Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT04205812

Trial Eligibility

Document

Title

  • Brief Title: Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer
  • Official Title: A Randomized, Double Blind, Phase 3 Study of Platinum-Based Chemotherapy With or Without INCMGA00012 in First-Line Metastatic Squamous and Nonsquamous Non-Small Cell Lung Cancer (POD1UM-304)

Clinical Trial IDs

  • ORG STUDY ID: INCMGA 0012-304
  • NCT ID: NCT04205812

Conditions

  • Metastatic Squamous Non-Small Cell Lung Cancer
  • Metastatic Nonsquamous Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
RetifanlimabINCMGA00012INCMGA00012 + chemotherapy (nonsquamous NSCLC)
PlaceboPlacebo + chemotherapy (nonsquamous NSCLC)
PemetrexedINCMGA00012 + chemotherapy (nonsquamous NSCLC)
CisplatinINCMGA00012 + chemotherapy (nonsquamous NSCLC)
CarboplatinINCMGA00012 + chemotherapy (nonsquamous NSCLC)
PaclitaxelINCMGA00012 + chemotherapy (squamous NSCLC)
nab-PaclitaxelINCMGA00012 + chemotherapy (squamous NSCLC)

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).

Trial Arms

NameTypeDescriptionInterventions
INCMGA00012 + chemotherapy (nonsquamous NSCLC)ExperimentalINCMGA00012 with pemetrexed + cisplatin OR carboplatin followed by INCMGA00012 plus pemetrexed until progression.
  • Retifanlimab
  • Pemetrexed
  • Cisplatin
  • Carboplatin
Placebo + chemotherapy (nonsquamous NSCLC)Active ComparatorPlacebo with pemetrexed + cisplatin OR carboplatin followed by placebo plus pemetrexed until progression. Participants assigned to placebo + chemotherapy will have the option of receiving open-label monotherapy INCMGA00012 in a crossover period after documentation of progressive disease.
  • Placebo
  • Pemetrexed
  • Cisplatin
  • Carboplatin
INCMGA00012 + chemotherapy (squamous NSCLC)ExperimentalINCMGA00012 with carboplatin + paclitaxel OR nab-paclitaxel followed by INCMGA00012 until progression.
  • Retifanlimab
  • Carboplatin
  • Paclitaxel
  • nab-Paclitaxel
Placebo + chemotherapy (squamous NSCLC)Active ComparatorPlacebo with carboplatin + paclitaxel OR nab-paclitaxel followed by placebo until progression. Participants assigned to placebo + chemotherapy will have the option of receiving open-label monotherapy INCMGA00012 in a crossover period after documentation of progressive disease.
  • Placebo
  • Carboplatin
  • Paclitaxel
  • nab-Paclitaxel

Eligibility 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

          -  Able to provide a formalin-fixed archival tumor tissue sample during screening, or a
             fresh tumor biopsy

          -  Measurable disease per RECIST v1.1.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

          -  Life expectancy of at least 3 months.

          -  Willingness to avoid pregnancy or fathering children.

          -  Adequate organ function as indicated by protocol-specified laboratory values.

        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.

          -  Thoracic radiation therapy of > 30 Gy within 6 months of the first dose of study
             treatment.

          -  History of peripheral neuropathy ≥ Grade 2 CTCAE v5 for participants who may receive
             cisplatin, paclitaxel, or nab-paclitaxel.

          -  Untreated central nervous system metastases and/or carcinomatous meningitis.

          -  Evidence or history of interstitial lung disease or noninfectious pneumonitis that
             required systemic steroids.

          -  Active infection requiring systemic therapy or active tuberculosis.

          -  Superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical
             cancer, or other in situ cancers.

          -  Has contraindications to chemotherapy agents used in the study.

          -  Has an active autoimmune disease that has required systemic treatment in past 2 years.

          -  Is receiving systemic antibiotics or steroid therapy ≤ 7 days prior to the first dose
             of study treatment.

          -  Has received a live vaccine within 30 days before the first dose of study treatment
             (and until 90 days after last dose of study drug).
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall survival (OS)
Time Frame:Approximately 4.5 years.
Safety Issue:
Description:Defined as the time from randomization until death due to any cause.

Secondary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:Approximately 4.5 years.
Safety Issue:
Description:Defined as the proportion of participants who have a confirmed complete response or partial response per RECIST v1.1 based on BICR.
Measure:Duration of response (DOR)
Time Frame:Approximately 4.5 years.
Safety Issue:
Description:Defined as the time from the earliest date of documented response until earliest date of disease progression (per RECIST v1.1 based on BICR) or death from any cause, whichever comes first.
Measure:Number of treatment-emergent adverse events
Time Frame:Approximately 4.5 years.
Safety Issue:
Description:Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 90 days after last dose of study treatment.
Measure:Cmax of INCMGA00012 when administered with chemotherapy
Time Frame:Approximately 4.5 years.
Safety Issue:
Description:Maximum observed plasma or serum concentration.
Measure:AUC of INCMGA00012 when administered with chemotherapy
Time Frame:Up to approximately 4.5 years.
Safety Issue:
Description:Area under the plasma or serum concentration curve.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • Metastatic
  • non-small cell lung cancer
  • nonsquamous
  • squamous
  • PD-1
  • PD-L1

Last Updated

July 29, 2021