A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer (NSCLC)
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ClinicalTrials.gov Identifier: NCT06333678 |
Recruitment Status :
Recruiting
First Posted : March 27, 2024
Last Update Posted : March 27, 2024
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Tracking Information | |||||||||
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First Submitted Date ICMJE | March 20, 2024 | ||||||||
First Posted Date ICMJE | March 27, 2024 | ||||||||
Last Update Posted Date | March 27, 2024 | ||||||||
Actual Study Start Date ICMJE | March 20, 2024 | ||||||||
Estimated Primary Completion Date | March 2027 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Progression-free survival (PFS) [ Time Frame: up to 3 years ] PFS will be defined as the time from randomization until progression or death , or from the time of randomization until the last follow up imaging (if no progression and alive). Progression will be evaluated by RECIST 1.1 guidelines.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures ICMJE |
Incidence of dose-limiting toxicity (DLT) [ Time Frame: 1 month after starting Sotorasib ] which we define as a hospitalization, life threatening condition, any death not clearly due to the underlying disease or extraneous causes, or therapy-related grade 3 or higher non-hematologic toxicity. The study will continue if the definition of "acceptable safety" is met.
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer (NSCLC) | ||||||||
Official Title ICMJE | A Randomized Phase II Study of Sotorasib Versus Continued Consolidation Durvalumab in Patients With KRAS G12C Mutant Locally Advanced Non-small Cell Lung Cancer (LANSCLC) With Persistent ctDNA Defined Minimal Residual Disease | ||||||||
Brief Summary | In this study, the researchers will look at whether having participants switch from durvalumab to sotorasib when they have detectable minimal residual disease (MRD) is an effective treatment approach for locally advanced non-small cell lung cancer (LA-NSCLC). The researchers will see whether this switch to sotorasib can control LANSCLC longer compared to the treatment approach of staying on durvalumab (and not switching to sotorasib). | ||||||||
Detailed Description | In the first phase of the randomized trial, defined as the Pre-Monitoring Phase, patients with LANSCLC with a KRAS G12C mutation who are planned to undergo, are undergoing, or very recently completed definitive chemoradiation with the plan for durvalumab consolidation are enrolled. Chemoradiation treatment and all clinical assessments during the Pre-Monitoring Phase are per standard of care as per institutional standards. Patients who (1) complete chemoradiation, (2) have detectable ctDNA post chemoradiation, (3) are without evidence of progressive disease on imaging, (4) and are planned to start durvalumab consolidation then continue into the Monitoring Phase. All other patients are no longer on trial and are taken off study. Patients in the Monitoring Phase will have ctDNA measured again early-on during durvalumab consolidation (i.e. cycle 3 of durvlalumab +/- 2 weeks) in conjunction with standard of care imaging. Patients with MRD will then continue to the Randomization Phase of trial. In the Randomization Phase patients will be randomized in a 1:1 fashion to continue standard of care durvalumab (group 1) vs. switch to sotorasib at 960 mg daily (group 2), with the primary endpoint of PFS. Patients switching to sotorasib will undergo a 28-day durvalumab washout and will receive sotorasib at 960 mg daily until progression. Washout will be confirmed by ensuring that cycle 1, day 1 of sotorasib is scheduled for at least 28 days after the most recent durvalumab dose. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Phase II randomized trial Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Non-Small Cell Lung Cancer | ||||||||
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 |
160 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | March 2027 | ||||||||
Estimated Primary Completion Date | March 2027 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria: Pre-Monitoring Phase
Monitoring Phase
Therapeutic Phase
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 | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT06333678 | ||||||||
Other Study ID Numbers ICMJE | 22-321 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Memorial Sloan Kettering Cancer Center | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Memorial Sloan Kettering Cancer Center | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Amgen | ||||||||
Investigators ICMJE |
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PRS Account | Memorial Sloan Kettering Cancer Center | ||||||||
Verification Date | March 2024 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |