Sacituzumab Tirumotecan Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer With EGFR Mutations or Other Genomic Alterations
Active, Not Recruiting
Trial purpose
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.
View full trial information on Clinicaltrials.govNATIONAL TRIAL REFERENCE NUMBER
NCT06074588
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Eligibility
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.
Conditions
Non-small Cell Lung Cancer
Age Range
18+
Sex
Male/Female
About the trial
Current trial Phase
Phase 3
Tests the medicine or vaccine in approximately 1,000 to 5,000 participants. For medicines, participants have the disease or condition the medicine is designed to treat. In vaccine trials, the participants may be healthy or have diseases or conditions. Phase 3 trials may happen in a doctor’s office, a clinic, or a hospital.
Trial start and end dates
- Trial start date 11-12-2023
- Estimated primary completion date 05-10-2027
- Estimated trial completion date 03-11-2030
Trial Locations
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.