Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients With Sensitive Small Cell Lung Cancer (SCLC)

Ipsen9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Small Cell Lung Cancer

Interventions

Diflomotecan (BN80915)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Overall objective response rate (tumour assessments should be performed every 6 weeks)

Secondary Outcomes

Time to tumour progression

Time to treatment failure

Duration of overall response

Overall complete response, partial response and stable disease

Time to response

Six month and one year survival rates

Median survival

Best overall response

Overall objective response rate

Data from ClinicalTrials.gov

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