OncoMatch/Clinical Trials/NCT05215340
Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations
Is NCT05215340 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Datopotamab Deruxtecan and Pembrolizumab for metastatic non small cell lung cancer.
Treatment: Datopotamab Deruxtecan · Pembrolizumab — This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer (NSCLC) of non-squamous histology.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Biomarker criteria
Required: EGFR wild-type
Documented negative test results for epidermal growth factor receptor (EGFR)...actionable genomic alterations (AGAs)
Required: ALK wild-type
Documented negative test results for...lymphoma kinase (ALK)...actionable genomic alterations (AGAs)
Required: ROS1 wild-type
Documented negative test results for...proto-oncogene1 (ROS1) actionable genomic alterations (AGAs)
Required: NTRK1 wild-type
No known AGAs in neurotrophic tyrosine receptor kinase (NTRK)...
Required: NTRK2 wild-type
No known AGAs in neurotrophic tyrosine receptor kinase (NTRK)...
Required: NTRK3 wild-type
No known AGAs in neurotrophic tyrosine receptor kinase (NTRK)...
Required: BRAF wild-type
No known AGAs in...proto-oncogene B-raf (BRAF)...
Required: RET wild-type
No known AGAs in...rearranged during transfection (RET)...
Required: MET wild-type
No known AGAs in...mesenchymal-epithelial transition factor (MET)...
Required: PD-L1 (CD274) high expression (TPS ≥50%) (TPS ≥50%)
Tumor has high programmed death receptor-1 (PD-L1) expression (TPS ≥50%) as determined by PD-L1 immunohistochemistry (IHC) 22C3 pharmDx assay by central testing
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic treatment for advanced or metastatic NSCLC
Has received prior systemic treatment for advanced or metastatic NSCLC
Cannot have received: topoisomerase I inhibitor (including antibody-drug conjugate)
Any agent, including an antibody-drug conjugate, containing a chemotherapeutic agent targeting topoisomerase I
Cannot have received: TROP2-targeted therapy
TROP2-targeted therapy
Cannot have received: anti-PD-1 therapy
Any anti-programmed death receptor-1 (PD-1), anti-PD-L1, or anti-PD-ligand 2 (L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137)
Cannot have received: immune checkpoint inhibitor
Any other immune checkpoint inhibitors
Lab requirements
Blood counts
Adequate bone marrow function within 7 days before randomization
Cardiac function
LVEF ≥50% by ECHO or MUGA within 28 days before randomization; no NYHA Class 2-4 CHF; QTcF ≤470 ms; no recent MI or uncontrolled angina
Has left ventricular ejection fraction (LVEF) ≥50% by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before randomization. Adequate bone marrow function within 7 days before randomization. Uncontrolled or significant cardiovascular disease, including: Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) interval >470 ms regardless of sex (based on the average of the 12-lead electrocardiogram determination at screening). Myocardial infarction within 6 months prior to randomization. Uncontrolled angina pectoris within 6 months prior to randomization. LVEF <50% by ECHO or MUGA scan within 28 days before randomization. New York Heart Association Class 2 to 4 congestive heart failure (CHF) at screening. Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) within 28 days before randomization.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ironwood Cancer and Research Center · Chandler, Arizona
- UCLA HemOnc - Clinical Research Unit · Los Angeles, California
- Compassionate Cancer Care Medical Group · Riverside, California
- UCSF Helen Diller Family Comprehensive Cancer Center · San Francisco, California
- Ridley-Tree Cancer Center · Santa Barbara, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify