A Study of Pembrolizumab With or Without Chemotherapy in Combination With Additional Treatments for Advanced Non-Small Cell Lung Cancer (NSCLC) (MK-3475-01G/KEYMAKER U01)

Researchers are investigating new treatments for untreated advanced non-small cell lung cancer (NSCLC), which is the most common form of lung cancer and lung cancer that has spread beyond surgical removal. Standard treatments include immunotherapy, such as pembrolizumab, and chemotherapy. This study aims to determine the effectiveness of adding other treatments, including the human epidermal growth factor receptor 3-directed antibody-drug conjugate (HER3-DXd) patritumab deruxtecan, to pembrolizumab, with or without chemotherapy. The primary goals are to assess safety and efficacy of the treatm

Trial Details

NCT ID
NCT06731907
Phase
PHASE2
Sponsor
Merck Sharp & Dohme LLC
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Pembrolizumab
  • Carboplatin
  • Paclitaxel
  • Nab-paclitaxel
  • Pemetrexed
  • HER3-DXd
Locations (sample)
  • Lexington, Kentucky, United States|37.98869,-84.47772
  • Baltimore, Maryland, United States|39.29038,-76.61219
  • Fargo, North Dakota, United States|46.87719,-96.7898
  • Philadelphia, Pennsylvania, United States|39.95238,-75.16362
  • Sioux Falls, South Dakota, United States|43.54369,-96.72796

Key Eligibility Criteria

  • The main inclusion criteria include but are not limited to the following:
  • Histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous non-small cell lung cancer (NSCLC) per American Joint Comm…
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 as assessed within 7 days before randomization.
  • Has archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been prov…

For full eligibility, visit ClinicalTrials.gov.

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