ClinicalTrials.gov posted results on 11 September 2026 for a completed Phase 2 study of lurbinectedin in adults with advanced gastrointestinal malignancies carrying DNA repair mutations. The study enrolled 8 participants; the posted data recorded 0 participants with an overall response at 12 weeks and median overall survival of 2.4 months.

Background

The study evaluated lurbinectedin, listed as a 4 mg injection under the brand name Zepzelca, in adults with advanced gastrointestinal malignancies with DNA repair mutations. The research was designed to assess the drug’s activity and safety in this population. The supplied record does not provide additional information about the drug’s mechanism, prior approvals, or disease prevalence.

Trial design

This completed Phase 2 trial, identified as NCT05229588, enrolled 8 participants with gastrointestinal malignancies. The intervention was lurbinectedin 4 mg injection. The record lists no primary-outcome entries, but posted measurements included overall response rate at 12 weeks, clinical benefit, tumor-marker normalization, progression-free survival, overall survival, survival rates, and adverse events possibly or definitely related to lurbinectedin. The supplied data do not identify a comparator arm.

Key results

The record reported 0 participants with an overall response at 12 weeks, 0 participants with clinical benefit, and 0 participants with normalization of tumor markers. Median progression-free survival was 1.2 months, and the progression-free survival rate at three months was 12.5%. The record did not provide confidence-interval values for these measures.

Median overall survival was 2.4 months. Overall survival rates were 14.3% at six months and 14.3% at 12 months. The posted adverse-event measurements possibly or definitely related to lurbinectedin listed counts of 0 participants, 2 participants, 0 participants, and 0 participants. The supplied data do not identify the categories represented by those four counts or provide a separate adverse-event summary.

What this means

In this small, completed Phase 2 study, the posted measurements showed no recorded responses, clinical benefit, or tumor-marker normalization, alongside short median progression-free and overall survival. Because the trial enrolled only eight participants, had no listed comparator, and did not include primary-outcome entries, the record does not establish comparative efficacy. The adverse-event counts are also insufficient to characterize the safety profile because their categories were not specified.

Source

Source: ClinicalTrials.gov, registry results for the completed Phase 2 study “Lurbinectedin in Patients With Advanced Gastrointestinal Malignancies With DNA Repair Mutations,” posted 11 September 2026. Available at clinicaltrials.gov/study/NCT05229588.