OncoMatch/Clinical Trials/NCT06074588
Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)
Is NCT06074588 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Sacituzumab tirumotecan and Docetaxel for non-small cell lung cancer (nsclc).
Treatment: Sacituzumab tirumotecan · Docetaxel · Pemetrexed — The purpose of this study is to evaluate sacituzumab tirumotecan versus chemotherapy (docetaxel or pemetrexed) for the treatment of previously-treated non-small cell lung cancer (NSCLC) with exon 19del or exon 21 L858R EGFR mutations (hereafter referred to as EGFR mutations or EGFR-mutated) or any of the follow genomic alterations: ALK gene rearrangements, ROS1 rearrangements, BRAF V600E mutations, NTRK gene fusions, MET exon 14 skipping mutations, RET rearrangements, or less common EGFR point mutations of exon 20 S768I, exon 21 L861Q, or exon 18 G719X mutations. The primary hypotheses are that sacituzumab tirumotecan is: (1) superior to chemotherapy with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations; and (2) superior to chemotherapy with respect to overall survival (OS) in NSCLC with EGFR mutations.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR mutation
Participants with genome mutations must have received 1 or 2 prior lines of epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), including a third generation TKI for participants with a T790M mutation
Required: EGFR T790M
Has an EGFR T790M mutation and has not received a third generation EGFR TKI (eg, osimertinib) [excluded]
Disease stage
Required: Stage III (NOT ELIGIBLE FOR RESECTION OR CURATIVE RADIATION), IV
Metastatic disease required
advanced (Stage III not eligible for resection or curative radiation) or metastatic non-squamous NSCLC
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: EGFR tyrosine kinase inhibitor
Participants with genome mutations must have received 1 or 2 prior lines of epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), including a third generation TKI for participants with a T790M mutation
Must have received: platinum-based chemotherapy — after progression on or after EGFR TKI
and 1 platinum-based therapy after progression on or after EGFR TKI
Cannot have received: systemic anticancer therapy
Exception: within 4 weeks or 5 half-lives (whichever is shorter) before randomization
Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before randomization
Cannot have received: trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate
Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC)
Cannot have received: topoisomerase I-containing antibody-drug conjugate
Received prior treatment with a topoisomerase I-containing ADC
Cannot have received: radiation therapy
Exception: completed palliative radiotherapy within 7 days of the first dose; radiation therapy to the lung >30 Gy within 6 months of the first dose
Completed palliative radiotherapy within 7 days of the first dose. Received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of study intervention
Cannot have received: investigational agent/device
Exception: within 4 weeks prior to study intervention administration
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCLA Hematology/Oncology - Santa Monica ( Site 0023) · Los Angeles, California
- Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0001) · Jacksonville, Florida
- Mid Florida Hematology and Oncology Center ( Site 0005) · Orange City, Florida
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003) · Marietta, Georgia
- Karmanos Cancer Institute ( Site 0018) · Detroit, Michigan
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