Clinical trial · Interventional
Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients With Sensitive Small Cell Lung Cancer (SCLC)
A Phase II Open Label Study Investigating the Activity of Diflomotecan (BN80915) Administered at the Fixed Dose of 7mg as a 20 Minute Intravenous Infusion Once Every 3 Weeks in Patients With Sensitive Small Cell Lung Cancer (SCLC) Who Have Failed First-line Treatment With a Platinum Based Regimen.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase II, open-label, multicenter, single-arm, exploratory "proof of concept" study. Diflomotecan (7 mg fixed dose) will be administered as a 20-minute IV infusion once every 3 weeks in patients with sensitive small cell lung cancer (SCLC) with progressive disease after first-line treatment with a platinum-based regimen.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diflomotecan (BN80915) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall objective response rate (tumour assessments should be performed every 6 weeks)
Secondary outcomes (9)
- measure
- Time to tumour progression
- measure
- Time to treatment failure
- measure
- Duration of overall response
- measure
- Overall complete response, partial response and stable disease
- measure
- Time to response
- measure
- Six month and one year survival rates
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Main Inclusion Criteria: * Documented small cell lung cancer (SCLC) * Measurable disease * One line of previous chemotherapy, including any platinum analogue, and excluding any camptothecin analogues, with objective response and relapsed no less than 3 months Main Exclusion Criteria: * Uncontrollable brain metastasis * Treated with an investigational drug within 30 days
References
Publications (0)
Data not yet available