A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) (AcceleRET-Lung)
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ClinicalTrials.gov Identifier: NCT04222972 |
Recruitment Status :
Recruiting
First Posted : January 10, 2020
Last Update Posted : February 2, 2023
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
Tracking Information | |||||
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First Submitted Date ICMJE | January 3, 2020 | ||||
First Posted Date ICMJE | January 10, 2020 | ||||
Last Update Posted Date | February 2, 2023 | ||||
Actual Study Start Date ICMJE | July 24, 2020 | ||||
Estimated Primary Completion Date | November 28, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Progression Free Survival (PFS) [ Time Frame: Estimated at up to 32 months ] Defined as the time from randomisation date to the first documented progressive disease (PD), as assessed by Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 central imaging review or death due to any cause, whichever occurs first.
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Original Primary Outcome Measures ICMJE |
Progression Free Survival (PFS) [ Time Frame: Estimated at up to 32 months ] Defined as the number of weeks from randomization date to the earlier of documented progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 central imaging review or death due to any cause
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) | ||||
Official Title ICMJE | A Phase III, Randomized, Open-Label Study of Pralsetinib Versus Standard of Care for First-Line Treatment of RET Fusion-Positive, Metastatic Non-Small Cell Lung Cancer | ||||
Brief Summary | This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcomes when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for participants with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease. Participants who have centrally confirmed progressive disease on the control arm have the option to crossover to pralsetinib. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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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. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
226 | ||||
Original Estimated Enrollment ICMJE |
250 | ||||
Estimated Study Completion Date ICMJE | June 25, 2026 | ||||
Estimated Primary Completion Date | November 28, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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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 |
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Listed Location Countries ICMJE | Argentina, Australia, Belgium, Brazil, Canada, Costa Rica, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States | ||||
Removed Location Countries | Hong Kong, Taiwan | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT04222972 | ||||
Other Study ID Numbers ICMJE | BO42864 2019-002463-10 ( EudraCT Number ) BLU-667-2303 ( Registry Identifier: CT.Gov ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Hoffmann-La Roche | ||||
Original Responsible Party | Blueprint Medicines Corporation | ||||
Current Study Sponsor ICMJE | Hoffmann-La Roche | ||||
Original Study Sponsor ICMJE | Blueprint Medicines Corporation | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Hoffmann-La Roche | ||||
Verification Date | February 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |