Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Maintenance Strategies in Advanced Non-Squamous NSCLC
NCT01631136Phase 3
Key facts
- Status
- Completed
- Start
- Jul 2012
- Primary completion
- May 2017
- Countries
- 1
- Sponsor
- IFCT
- Modality
- Small Molecules
- Conditions
- Nonsquamous Non-Small Cell Lung Cancer (nsNSCLC)
01
Overview
Phase 3, randomised, open-label trial of pemetrexed and gemcitabine in Nonsquamous Non-Small Cell Lung Cancer (nsNSCLC) (2 arms), sponsored by IFCT. Primary endpoint: Overall Survival at 20 months. Started Jul 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Continuous Maintenance
Cisplatin + Pemetrexed induction followed by Pemetrexed maintenance.
Response-Adapted Maintenance
Cisplatin + Gemcitabine induction followed by Gemcitabine (if response) or Pemetrexed (if stable).
03
Who it enrols
Patients with stage IV non-squamous NSCLC, aged 18-70, PS 0-1, with no EGFR mutation or ALK rearrangement, and no prior anti-tumoral treatment.
04
Endpoints
Primary
Overall Survival
Secondary
Progression-Free Survival
Objective Response Rate
Safety Analysis
Treatment Exposure
Beyond the preview
Go deeper on NCT01631136.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT01631136.