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Descriptive Information | |||||
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Brief Title ICMJE | Survival Prolongation by Rationale Innovative Genomics | ||||
Official Title ICMJE | A Proof of Concept Study to Explore Safety and Efficacy of Tri-therapy Approach in Advanced/Metastatic NSCLC and Retrospectively Assess the Ability of Integrated Genomics and Transcriptomics to Match Patients to the Combination | ||||
Brief Summary | Patients with advanced/metastatic non-small cell lung cancer (NSCLC) with no documented targetable alterations (Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic Lymphoma Kinase (ALK) translocation, ROS1 mutation if available or MET exon 14 skipping mutation if available) will receive a tri-therapy associating avelumab, axitinib and palbociclib. | ||||
Detailed Description | During the Phase 1 (approximately 30 patients), the tri-therapy will be tested at different doses following a specific dose-escalation scheme (3 + 3 model) in order to establish the safety and identify the Maximum Tolerated Dose (MTD) and recommended dose (RP2D) for the Phase 2. The phase 2 will confirm the safety and will assess the clinical utility of the tri-therapy approach in the treatment of advanced/metastatic NSCLC (100 patients). The study will also explore the clinical utility of the Simplified Interventional Mapping System (SIMS), a new tool/algorithm enabling matching of NSCLC patients with combination therapy. For this purpose tumor/metastasis and matched normal tissue biopsies will be requested in order to obtain sequencing and expression profiles. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Avelumab, Axitinib, Palbociclib
For the Phase 1: Avelumab is administered intravenously (IV) on Day 1 and Day 15 of each Cycle (one cycle = 28 days) in combination with axitinib po bid and palbociclib po (7 days off; 21 days on). For the Phase 2: Avelumab, axitinib and palbociclib are administered at the recommended dose (RP2D) as determined during the phase 1 part of the study. Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 130 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | October 2024 | ||||
Estimated Primary Completion Date | October 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | ELIGIBILITY CRITERIA
EXCLUSION CRITERIA
Clinical criteria for phase 1 and phase 2 studies:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | France, Israel, Luxembourg, Spain, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03386929 | ||||
Other Study ID Numbers ICMJE | WIN001 2017-001455-32 ( EudraCT Number ) | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Worldwide Innovative Networking Association | ||||
Study Sponsor ICMJE | Worldwide Innovative Networking Association | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Worldwide Innovative Networking Association | ||||
Verification Date | June 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |