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

• Conditions: on small-cell lung cancer (NSCLC); MedDRA version: 14.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-001050-25-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-30
• Last Update Posted: 11 April 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 not amenable to combined modality treatment) or recurrent or metastatic (Stage IV) non-small cell lung cancer.
2. Patients must 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 18 years or older and able to sign Informed Consent.
5. Patients must be suitable and willing to undergo mandatory baseline biopsy according to treating institution’s own guidelines and requirements for such procedure. No baseline biopsy is required for patients with known resistance mechanisms to EGFR TKI and available tumor material
6. WHO performance status of 0-1.
7. Measurable disease according to RECIST v.1.1 (Irradiated lesions can not be considered measurable unless they have clearly progressed since radiotherapy).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 94
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

Exclusion Criteria

?1. Patients who have received more than two prior lines of antineoplastic therapy for advanced disease. Chemotherapy administered as adjuvant treatment more than six months prior to study enrollment is not considered a prior line of therapy for purposes of
this study.
2. Patients who have received any antineoplastic treatment between EGFR TKI discontinuation and study start.
3. Evidence of spinal cord compression or current evidence of CNS metastases. Screening CT/MRI of the brain is mandatory.
4. Patients who have received EGFR TKI (e.g. erlotinib, gefitinib) within = 5 half-lives of the agent or active metabolites of the of starting the study. All associated toxicities (with
the exception of alopecia) should be resolved to baseline or less prior to treatment start.
5. Patients who received radiation therapy for management of local disease within four weeks (RT for palliative pain management is allowed). All associated toxicities (with the
exception of alopecia) should be resolved to grade 1 or less prior to treatment start.
6. Prior treatment with an HSP90 inhibitor

Study & Design

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