Kelun-Biotech adds a fourth NSCLC combination trial for sacituzumab tirumotecan
The new Phase 2 study pairs the TROP2 antibody-drug conjugate with SKB118 and folds into a lung-cancer program Merck already runs three later-stage trials against.
Executive Summary
- Kelun-Biotech registered a new combination study for its TROP2-targeted antibody-drug conjugate, adding to an already extensive lung-cancer development program for the drug.
- The study is built around tolerability and early tumor response, positioning it as a dose-and-activity read rather than a survival-focused registrational trial.
- The combination enters a TROP2 field where the same drug already runs several later-stage NSCLC trials, and where rival ADCs targeting other receptors are advancing through Phase 3 in the same tumor type.
- The trial reflects a sponsor with a substantial multi-drug pipeline and a completion track record on its concluded trials, backing an incremental line extension rather than a new bet.
The new study
The trial, filed as NCT07697586 and titled "SKB264 in Combination With SKB118 for Non-Small Cell Lung Cancer," plans to enroll 206 patients with locally advanced or metastatic NSCLC who lack EGFR-sensitizing mutations or ALK fusions. It is listed as Not yet recruiting, with a start date of August 2026 and a primary completion date of August 2028. The study is Phase 2 and not registrational, positioning it as a mid-stage combination test rather than an approval-seeking trial. NCT07697586SKB264 in Combination With SKB118 for Non-Small Cell Lung CancerNCT07697586
The endpoint bar
The registered primary outcome is the number of participants with treatment-related adverse events, dose-limiting toxicities, and clinically significant lab abnormalities, tracked from enrollment through 24 months of treatment. Objective response rate by RECIST v1.1 is also listed as primary, with disease control rate, duration of response, progression-free survival, and overall survival as secondary measures over the same window. That combination of adverse-event tracking alongside response rate means the trial is built to establish whether adding SKB118 changes the tolerability of sacituzumab tirumotecan before any efficacy signal is read as decision-grade. NCT07697586SKB264 in Combination With SKB118 for Non-Small Cell Lung CancerNCT07697586
Program context
Sacituzumab tirumotecan already carries a dense NSCLC footprint through Kelun-Biotech's own trial portfolio, which includes Phase 3 studies against chemotherapy and against pembrolizumab and a recruiting Phase 2 neoadjuvant study in EGFR-mutated, resectable disease. The new trial adds a fifth NSCLC study to that footprint rather than opening a new indication.
Competitive field
The TROP2 target in NSCLC is not sparse: Merck's own sacituzumab tirumotecan development runs three Phase 3 trials outside lung cancer completing between 2032 and 2033, and Datopotamab deruxtecan, a rival TROP2 antibody-drug conjugate from AstraZeneca and Daiichi Sankyo, carries multiple active NSCLC studies. Field-wide activity for TROP2 has declined to a ratio of 0.38 recent-to-older trials, consistent with a target class that has moved past its earliest exploratory phase into consolidation. Kelun-Biotech's own completion record stands at 6 of 8 trials completed, with 2 terminated.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.