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NVALT10: Erlotinib +/- Chemotherapy in Advanced NSCLC
NCT00835471Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2009
- Primary completion
- Jun 2014
- Countries
- 1
- Sponsor
- NVALT
- Modality
- Small Molecules
- Drugs
- erlotinib
- Conditions
- non-small cell lung cancer (NSCLC)
01
Overview
Phase 2, randomised, open-label trial of erlotinib in non-small cell lung cancer (NSCLC) (2 arms), sponsored by NVALT. Primary endpoint: Progression Free Survival at 36 months. Started Mar 2009; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Erlotinib + Chemo
Erlotinib intercalated with Docetaxel (squamous) or Pemetrexed (non-squamous) for 4 cycles, then Erlotinib maintenance.
Erlotinib Monotherapy
Erlotinib continuous monotherapy.
03
Who it enrols
Patients with stage IIIB/IV NSCLC who have progressed after 1-2 cytotoxic regimens (including a platinum agent). Must have adequate organ function and ECOG PS 0-2. Excludes patients with prior EGFR-TKI therapy or prior treatment with the specific chemotherapy agent designated for their histology (pemetrexed for non-squamous, docetaxel for squamous).
04
Endpoints
Primary
Progression Free Survival
Secondary
Number of Adverse Events
Overall Survival
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