An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations
The purpose of this study was to determine if AUY922 had superior efficacy when compared to chemotherapy agents docetaxel or pemetrexed in patients whose tumor had EGFR mutations. The primary purpose of this study was to compare the efficacy of AUY922, when administered i.v. on a once-weekly schedule at 70 mg/m2, versus docetaxel or pemetrexed in adult patients with advanced NSCLC, whose tumors harbored EGFR activating mutations, and had developed resistance to EGFR TKI.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jul 24, 2019 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Novartis Pharmaceuticals
- Interventions being studied
- Drug: AUY922; Drug: Docetaxel; Drug: Pemetrexed
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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. 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
1. Patients who have received more than two prior lines of antineoplastic therapy for advanced disease. Chemotherapy administered as neoadjuvant or adjuvant treatment more than six months prior to study enrollment is not considered a prior line of therapy for purposes of this study. 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Cedars Sinai Medical Center Dept.of Cedars-Sinai Med. Ctr.Los Angeles, California
- Maryland Oncology Hematology, P.A. SCRockville, Maryland
- University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 5Madison, Wisconsin
- Novartis Investigative SiteMarseille, Bouches Du Rhone
- Novartis Investigative SiteCréteil
- Novartis Investigative SiteVillejuif
- Novartis Investigative SiteHong Kong
- Novartis Investigative SiteMonza, MB
- Novartis Investigative SiteMilan, MI
- Novartis Investigative SiteParma, PR
- Novartis Investigative SiteOrbassano, TO
- Novartis Investigative SiteKoto Ku, Tokyo
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 24, 2019. Always confirm current availability with the study team.