KEYMAKER-U01 Substudy 01G: A Phase 2, Umbrella Study With Rolling Arms of Investigational Agents in Combination With Pembrolizumab With or Without Platinum-based Chemotherapy in Treatment-Naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)
Merck Sharp & Dohme LLC
Summary
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 treatments.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion 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 Committee on Cancer (AJCC) Staging Manual Version 8. * 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 provided. * Human immunode…
Interventions
- BiologicalPembrolizumab
Pembrolizumab 200mg IV Infusion.
- DrugCarboplatin
Carboplatin IV infusion AUC5 or 6 mg/mL•min and not exceeding 900mg.
- DrugPaclitaxel
Paclitaxel 200 mg/m\^2 IV infusion.
- DrugNab-paclitaxel
Nab-paclitaxel 100mg/m\^2 IV infusion.
- DrugPemetrexed
Pemetrexed 500mg/m\^2 IV infusion.
- BiologicalHER3-DXd
HER3-Dxd 5.6mg/kg IV infusion.
Locations (41)
- University of Kentucky ( Site 0019)Lexington, Kentucky
- MedStar Franklin Square Medical Center ( Site 0033)Baltimore, Maryland
- Sanford Fargo Medical Center ( Site 0039)Fargo, North Dakota
- Abramson Cancer Center ( Site 0010)Philadelphia, Pennsylvania
- Sanford Cancer Center ( Site 0038)Sioux Falls, South Dakota
- Centro de Estudios Clínicos SAGA ( Site 0162)Santiago, Region M. de Santiago