A randomized phase III trial of erlotinib versus docetaxel in patients with advanced squamous cell non-small cell lung cancer who failed first line platinum based doublet chemotherapy stratified by VeriStrat Good vs VeriStrat Poor (EMPHASIS, NVALT13, ETOP 3-12)
- Conditions
- non-small cell lung cancerlung cancer10029107
- Registration Number
- NL-OMON38457
- Lead Sponsor
- European Thoracic Oncology Platform (ETOP)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 160
* Histologically/cytologically proven stage III or IV squamous NSCLC.
* Progressive disease upon or after previous chemotherapy including at least one line of platinum-based chemotherapy.
* Measurable or evaluable disease.
* Age * 18 years.
* ECOG Performance Status of 0 * 2.
* Life expectancy of at least 12 weeks.
* Adequate contraception for females of childbearing potential during the study and in the 12 months thereafter.
* Adequate contraception for male participants during the study.
* Previous treatment with EGFR-TKI or docetaxel.
* Documented brain metastasis. Exceptions: see protocol page 10.
* Documented presence of activating EGFR mutations, if the patient was tested for EGFR mutations.
* Pregnancy or lactation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Progression free survival.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Objective response rate and disease control rate, overall survival, safety.</p><br>