A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC) (LIBRETTO-432)
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|ClinicalTrials.gov Identifier: NCT04819100|
Recruitment Status : Not yet recruiting
First Posted : March 26, 2021
Last Update Posted : June 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung||Drug: Selpercatinib Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||LIBRETTO-432: A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib Following Definitive Locoregional Treatment in Participants With Stage IB-IIIA RET Fusion-Positive NSCLC|
|Estimated Study Start Date :||October 31, 2021|
|Estimated Primary Completion Date :||August 31, 2028|
|Estimated Study Completion Date :||November 30, 2032|
Selpercatinib administered orally.
Placebo Comparator: Placebo
Placebo administered orally.
- Event-Free Survival (EFS) [ Time Frame: Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years) ]EFS by Investigator Assessment in the Primary Analysis Population
- EFS [ Time Frame: Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years) ]EFS by investigator assessment in the overall population
- Overall Survival (OS) [ Time Frame: Randomization to death from any cause (estimated as up to 9 years)] ]OS
- EFS [ Time Frame: Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)] ]EFS by blinded independent central review (BICR)
- Time to Distant Disease Recurrence in the Central Nervous System (CNS) [ Time Frame: Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years) ]Time to distant disease recurrence in the CNS by investigator assessment and BICR
- Progression Free Survival on the Next Line of Treatment (PFS2) [ Time Frame: Randomization to disease progression on the next line of treatment or death from any cause (estimated as up to 9 years) ]PFS2 by investigator assessment
- Positive Predictive Value (PPV) of Local Lab Tests Compared to Central Lab Test to Detect Rearranged during Transfection (RET) Gene Fusion [ Time Frame: Baseline ]PPV of local lab tests compared to central lab test to detect RET gene fusion
- Mean Change from Baseline over Time in NSCLC Symptoms [ Time Frame: Baseline to treatment discontinuation (estimated as up to 3 years) ]NSCLC symptoms will be measured using the 7-item NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ). The NSCLC-SAQ measures the severity/frequency of the following core symptoms: Cough, pain, dyspnea, fatigue, and appetite. Raw scores range from 0 to 4 and the total score ranges from 0-20. Higher scores represent worse symptoms.
- Mean Change from Baseline over Time in Physical Function [ Time Frame: Baseline to treatment discontinuation (estimated as up to 3 years) ]Physical function will be measured by the 5 physical function items in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) (also known as the EORTC IL 19 questionnaire). Raw scores range from 0-20. Higher scores indicate worst function.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04819100
|Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or||1-317-615-4559||ClinicalTrials.email@example.com|
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|