A Study of Intismeran Autogene (V940)/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013)

Researchers want to know if intismeran autogene (the study treatment) given with pembrolizumab and chemotherapy can treat metastatic treatment-naive squamous non-small cell lung cancer (NSCLC). Intismeran autogene is designed to help a person's immune system attack their specific cancer. The goal of this study is to learn if people who receive intismeran autogene with pembrolizumab and chemotherapy live longer overall and without the cancer growing or spreading compared to people who receive placebo with pembrolizumab and chemotherapy. A placebo looks like the study treatment but has no study

Trial Details

NCT ID
NCT07221474
Phase
PHASE2
Sponsor
Merck Sharp & Dohme LLC
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • Intismeran Autogene
  • Pembrolizumab
  • Carboplatin
  • Paclitaxel
  • Nab-paclitaxel
  • Placebo
Locations (sample)
  • Tampa, Florida, United States|27.94752,-82.45843
  • St Louis, Missouri, United States|38.62727,-90.19789
  • Paramus, New Jersey, United States|40.94454,-74.07542
  • Cleveland, Ohio, United States|41.4995,-81.69541
  • Nashville, Tennessee, United States|36.16589,-86.78444

Key Eligibility Criteria

  • Inclusion Criteria include, but are not limited to:
  • Has a histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) (Stage IV: M1a, M1b, M1c1, M1c2, AJCC Stag…
  • Has measurable disease per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology
  • Has provided a tissue sample that is collected either at the time of or after the diagnosis of metastatic disease AND is from a site not previously…

For full eligibility, visit ClinicalTrials.gov.

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