OncoMatch/Clinical Trials/NCT06731907
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)
Is NCT06731907 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for non-small cell lung cancer.
Treatment: Pembrolizumab · Carboplatin · Paclitaxel · Nab-paclitaxel · Pemetrexed · HER3-DXd — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR tumor-activating mutation
Participants with squamous histology are excluded if there is a known tumor-activating epidermal growth factor receptor (EGFR) mutation
Required: ALK fusion
Participants with squamous histology are excluded if there is a known...anaplastic lymphoma kinase (ALK)...gene rearrangement
Required: ROS1 gene rearrangement
Participants with squamous histology are excluded if there is a known...c ros oncogene 1 (ROS1) gene rearrangement
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anticancer therapy
Has received prior systemic anticancer therapy for their metastatic NSCLC.
Cannot have received: anti-PD-1 therapy
Has received prior therapy with an anti- programmed cell death 1 protein (anti-PD-1), anti- programmed cell death ligand 1 protein (anti-PD-L1), or anti- programmed cell death ligand 2 protein (anti-PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
Cannot have received: topoisomerase I inhibitor
Has received prior treatment with a topoisomerase I inhibitor or an anti-HER3 antibody and/or ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor.
Cannot have received: anti-HER3 antibody
Has received prior treatment with a topoisomerase I inhibitor or an anti-HER3 antibody and/or ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor.
Cannot have received: antibody-drug conjugate
ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor.
Lab requirements
Cardiac function
No myocardial infarction within 6 months, NYHA Class 3 or 4 CHF, uncontrolled angina within 6 months, cardiac arrhythmia requiring ongoing antiarrhythmic treatment, history of clinically relevant ventricular arrhythmias, bradycardia <50 bpm unless pacemaker, history of second- or third-degree heart block unless pacemaker and no history of fainting or clinically relevant arrhythmia, no coronary/peripheral artery bypass graft within 6 months, no complete left bundle branch block.
Has myocardial infarction within 6 months. Has New York Heart Association (NYHA) Classes 3 or 4 congestive heart failure. Has uncontrolled angina pectoris within 6 months. Has cardiac arrhythmia requiring ongoing antiarrhythmic treatment. Has history of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes. Has bradycardia of less than 50 beats per minute (bpm) unless the participant has a pacemaker. Has history of second- or third-degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers and have no history of fainting or clinically relevant arrhythmia with pacemakers. Has coronary/peripheral artery bypass graft within 6 months. Has complete left bundle branch block.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- 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
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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