An open-label, randomized phase II study to evaluate the efficacy of AUY922 vs pemetrexed or docetaxel in NSCLC patients with EGFR mutations

• Conditions: SCLC; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-001050-25-ES
• Lead Sponsor: ovartis Farmaceutica S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-26
• Last Update Posted: 24 November 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. patients with histologically or cytologically documented, locally advanced (stage IIIB who are amenable to combined modality treatment) or recurrent or metastatic (Stage IV) non-small cell lung cancer.
2. Patients that have EGFR gene mutation in their tumors
3. Patients must have documented clinical benefit (CR, PR, or patients with SD for 6 months or greater) on prior EGFR TKI (e.g. erlotinib or gefitinib) followed by documented progression according to RECIST.
4. Patients must be suitable and willing to undergo mandatory baseline biopsy according to treating institution's own guidelines and requirements for such procedure.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 84
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

1. Patients who have received more than two prior lines of antineoplastic therapy for advanced disease.
2. Evidence of spinal cord compression or current evidence of CNS metastases. Screening CT/MRI of the brain is mandatory.
3. Prior treatment with an HSP90 inhibitor.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified