Trial intelligence / Profile preview

i3T: Tirapazamine + Cisplatin + Vinorelbine in NSCLC

NCT00017459Phase 3

Key facts

Status: Completed
Start: Jul 2000
Countries: 1
Sponsor: Sanofi
Modality: Small Molecules

Drugs: tirapazamine
Conditions: non-small cell lung cancer (NSCLC)

Overview

Phase 3, randomised, open-label trial of tirapazamine in non-small cell lung cancer (NSCLC) (2 arms), sponsored by Sanofi. Primary endpoint: Overall Survival. Started Jul 2000; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Tirapazamine + Cisplatin + Vinorelbine
Tirapazamine IV over 2 hours followed by Cisplatin IV over 1 hour on day 1. Vinorelbine IV on days 1, 8, 15, and 22. Repeats every 28 days.
Cisplatin + Vinorelbine
Cisplatin and Vinorelbine as in Arm I. Repeats every 28 days.

Who it enrols

Patients with histologically or cytologically confirmed Stage IIIB or IV NSCLC, aged 18 or older, with Karnofsky performance status 70-100%, and adequate organ function. No prior chemotherapy or biologic therapy for NSCLC.

Endpoints

Primary

Overall Survival

Secondary

Objective Response Rate
Time to Progression
Time to Treatment Failure
Clinical Benefit
Toxicity and Safety
Quality of Lifeevery 8 weeks for 2-3 years

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