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The trial is taking place at:
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Communal Non-Profit Enterprise Regional Center of Oncology | Kharkiv, Ukraine

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Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer (POD1UM-304)

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Incyte

Status and phase

Active, not recruiting
Phase 3

Conditions

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

Treatments

Drug: nab-Paclitaxel
Drug: Paclitaxel
Drug: Placebo
Drug: Retifanlimab
Drug: Carboplatin
Drug: Pemetrexed
Drug: Cisplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT04205812
INCMGA 0012-304

Details and patient eligibility

About

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).

Enrollment

583 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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. - Has been fully vaccinated against SARS-CoV-2 or is willing and able to be fully vaccinated against SARS-CoV-2 during the study by starting the vaccination process during screening.

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. Note: If required by country or local regulations to be tested for COVID-19 during screening, a participant should be excluded if they have a positive test result for SARS CoV-2 infection until both the retesting result is negative and clinical recovery is obtained.
  • 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).

Note: While based on approved SARS-CoV-2 vaccines available worldwide, many vaccines are not live (mRNA and adenovirus vaccines do not contain live virus), if a live vaccine against SARS-CoV-2 is the only available option, prior consultation with the medical monitor should be obtained.

• Has known active HBV or HCV (testing must be performed to determine eligibility)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

583 participants in 4 patient groups

INCMGA00012 + chemotherapy (nonsquamous NSCLC)
Experimental group
Description:
INCMGA00012 with pemetrexed + cisplatin OR carboplatin followed by INCMGA00012 plus pemetrexed until progression.
Treatment:
Drug: Cisplatin
Drug: Carboplatin
Drug: Pemetrexed
Drug: Retifanlimab
Placebo + chemotherapy (nonsquamous NSCLC)
Active Comparator group
Description:
Placebo 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.
Treatment:
Drug: Cisplatin
Drug: Carboplatin
Drug: Pemetrexed
Drug: Placebo
INCMGA00012 + chemotherapy (squamous NSCLC)
Experimental group
Description:
INCMGA00012 with carboplatin + paclitaxel OR nab-paclitaxel followed by INCMGA00012 until progression.
Treatment:
Drug: Carboplatin
Drug: Retifanlimab
Drug: Paclitaxel
Drug: nab-Paclitaxel
Placebo + chemotherapy (squamous NSCLC)
Active Comparator group
Description:
Placebo 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.
Treatment:
Drug: Carboplatin
Drug: Placebo
Drug: Paclitaxel
Drug: nab-Paclitaxel

Trial contacts and locations

141

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Data sourced from clinicaltrials.gov

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