A multicenter, open-label, randomized phase II study to evaluate the efficacy of AUY922 vs pemetrexed or docetaxel in NSCLC patients with EGFR mutations who have progressed on prior EGFR TKI treatment (CAUY922A2207)
- Conditions
- non-small cell lung cancer10029107lung cancer
- Registration Number
- NL-OMON39976
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
* 18 years and above.
* Histologically or cytologically documented stage IIIB or IV NSCLC.
* EGFR gene mutation in the tumor.
* Documented clinical benefit (CR, PR, or SD for *6 months) on prior EGFR TKI followed by documented progression.
* Patients must have received platinum based prior treatment.
* WHO performance status 0-1.
* Measurable disease.
* More than two prior lines of antineoplastic therapy for advanced disease.
* Evidence of CNS involvement. Brain CT/MRI mandatory. Note: treated and stable CNS metastasis allowed.
* Radiation therapy for management of local disease within four weeks (RT for palliative pain management is allowed).
* Prior treatment with an HSP90 inhibitor.
* Impaired cardiac function (see protocol page 34 for details).
* Women of childbearing potential not using adequate contraception, pregnancy, lactation.
* Sexually active men not using adequate contraception.
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>Overall response rate, disease control rate, overall survival, toxicity, PK.</p><br>