Small Cell Lung Cancer
Conditions
Brief summary
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.
Interventions
DRUGDiflomotecan (BN80915)
Sponsors
Ipsen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall objective response rate (tumour assessments should be performed every 6 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to treatment failure | — |
| Duration of overall response | — |
| Overall complete response, partial response and stable disease | — |
| Time to response | — |
| Time to tumour progression | — |
| Median survival | — |
| Best overall response | — |
| Overall objective response rate | — |
| Six month and one year survival rates | — |
Outcome results
None listed