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

Phase 1

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

• Registration Number: EUCTR2012-001050-25-PL
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-05
• Last Update Posted: 23 May 2016

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. This can be source documented by one of the following:
• Provide a pathology report that indicates the patient’s tumor had EGFR activating
mutation in the past.
Or:
• Perform testing (local or central) in an archival tumor or a fresh baseline biopsy tumor
tissue to show the presence of EGFR activating mutation.
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 have received prior platinum containing treatment
5.WHO performance status of 0-1

Other protocol-defined inclusion criteria may apply
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. Note: Patients who have been treated for
CNS metastases by radiation or gamma knife surgery, who been stable for at least 2 months and have
discontinued high dose corticosteroids will be eligible for protocol participation
3. Prior treatment with an HSP90 inhibitor.

Other protocol-defined exclusioncriteria may apply

Study & Design

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