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) (POD1UM-304)

  • STATUS
    Recruiting
  • End date
    Aug 1, 2025
  • participants needed
    600
  • sponsor
    Incyte Corporation
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Updated on 19 December 2022
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Summary

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).

Description


Details
Condition Metastatic Squamous Non-Small Cell Lung Cancer, Metastatic Nonsquamous Non-Small Cell Lung Cancer
Treatment cisplatin, carboplatin, Placebo, Paclitaxel, Pemetrexed, Nab-paclitaxel, Retifanlimab
Clinical Study IdentifierNCT04205812
SponsorIncyte Corporation
Last Modified on19 December 2022

Eligibility

 Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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