An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations
NCT ID: NCT01646125
Last Updated: 2019-07-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
59 participants
INTERVENTIONAL
2012-11-23
2015-11-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pemetrexed Disodium and Hsp90 Inhibitor AUY922 in Treating Patients With Previously Treated Stage IV Non-Small Cell Lung Cancer
NCT01784640
A Study of AUY922 in Non-small-cell Lung Cancer Patients Who Have Received Previous Two Lines of Chemotherapy.
NCT01124864
Phase 2 Study of AUY922 in NSCLC Patients With Exon 20 Insertion Mutations in EGFR
NCT01854034
A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy
NCT02008227
A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110]
NCT02409342
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AUY922 arm
Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.
AUY922 was to be administered weekly.
AUY922
AUY922 was to be given by i.v. once weekly at 70 mg/m2 until disease progression, death or any other reason for discontinuation from study treatment.
chemotherapy arm
Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.
Pemetrexed or docetaxel was to be was to be given once every three weeks.
Docetaxel
Docetaxel was to be given i.v. once every 3 weeks at 75 mg/m2 until progression or unacceptable toxicity
Pemetrexed
Pemetrexed was to be given once every 3 weeks at 500 mg/m2 until progression or unacceptable toxicity
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AUY922
AUY922 was to be given by i.v. once weekly at 70 mg/m2 until disease progression, death or any other reason for discontinuation from study treatment.
Docetaxel
Docetaxel was to be given i.v. once every 3 weeks at 75 mg/m2 until progression or unacceptable toxicity
Pemetrexed
Pemetrexed was to be given once every 3 weeks at 500 mg/m2 until progression or unacceptable toxicity
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cedars Sinai Medical Center Dept.of Cedars-Sinai Med. Ctr.
Los Angeles, California, United States
Maryland Oncology Hematology, P.A. SC
Rockville, Maryland, United States
University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 5
Madison, Wisconsin, United States
Novartis Investigative Site
Marseille, Bouches Du Rhone, France
Novartis Investigative Site
Créteil, , France
Novartis Investigative Site
Villejuif, , France
Novartis Investigative Site
Hong Kong, , Hong Kong
Novartis Investigative Site
Monza, MB, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Parma, PR, Italy
Novartis Investigative Site
Orbassano, TO, Italy
Novartis Investigative Site
Koto Ku, Tokyo, Japan
Novartis Investigative Site
Amsterdam, , Netherlands
Novartis Investigative Site
Groningen, , Netherlands
Novartis Investigative Site
Bergen, , Norway
Novartis Investigative Site
Oslo, , Norway
Novartis Investigative Site
Gdansk, , Poland
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, Seocho Gu, South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Kuei-Shan Chiang, Taoyuan/ Taiwan ROC, Taiwan
Novartis Investigative Site
Taichung, , Taiwan
Novartis Investigative Site
Taipei, , Taiwan
Novartis Investigative Site
Leicester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-001050-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAUY922A2207
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.