Non small cell lung cancer
Conditions
Interventions
Product Code: AUY922
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: AUY922
Concentration unit: mg/ml milligram(s)/mill
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare PFS in patients with advanced NSCLC whose tumors harbor EGFR activating mutations and have progressed on EGFR TKI treatment treated with AUY922 versus pemetrexed or docetaxel.; Secondary Objective: - To compare OS between the treatment arms - To compare the Overall Response Rate (ORR) between the treatment arms - To compare the Disease Control Rate (DCR) duration between the treatment arms - To compare Time to Progression (TTP) between the treatment arms - To compare Duration of Response (DOR) between the treatment arms - To evaluate safety and tolerability of administering AUY922 in the treatment of NSCLC compared to pemetrexed or docetaxel - To perform exploratory evaluations on available tumor-tissue for biological or genomic determinants of outcome, included but not limited to acquired resistance mechanism to EGFR TKI such as T790M mutation or cMet amplification ;Primary end point(s): Progression free survival (PFS) based on local investigator assessment per RECIST 1.1;Timepoint(s) of evaluation of this end point: durarion of the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. overall survival (OS) 2. overall response rate (ORR) 3. disease control rate (DCR) 4. time to progression (TTP) 5. duration of response (DOR) 6. rate of adverse events (AEs) 7. rate of serious adverse events (SAEs) ; Timepoint(s) of evaluation of this end point: 1. from randomization to death 2-7. treatment duration | — |
Countries
France, Hong Kong, Israel, Italy, Korea, Republic of, Netherlands, Norway, Poland, Singapore, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactMedical Information Services
Novartis Pharmaceuticals UK Ltd
Outcome results
None listed