NCT 06074588
Brief Summary
The purpose of this study is to evaluate sacituzumab tirumotecan versus chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells (docetaxel or pemetrexed) for the treatment of previously-treated non-small cell lung cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs (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.
Intervention / Treatment
- Biological: Sacituzumab tirumotecan
- Drug: Docetaxel
- Drug: Pemetrexed
Inclusion Criteria:
- Histologically- or cytologically-documented advancedat a late stage, far along (Stage III not eligible for resectionsurgical removal of tissue or part/all of an organ or curative radiation) or metastatic non-squamous NSCLC with specific mutations.
- Documentation of locally assessed radiological disease progression while on or after last treatment based on Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1.
- 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; and 1 platinum-based therapy after progression on or after EGFR TKI.
- Measurable disease per RECIST 1.1 as assessed by the local site investigator.
- Archival tumor tissuea group of cells that work together to perform a function sample or newly obtained core, incisional, or excisional biopsyremoval of a section of tissue to analyse for cancer cells of a tumor lesion not previously irradiated has been provided
- Participants who have AEs due to previous anticancer therapies must have recovered to Gradea description of how abnormal cancer cells and tissue look under a microscope when compared to healthy cells ≤1 or baseline.
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
- Have an ECOG performance status of 0 or 1 within 3 days before randomization.