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A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC) (LIBRETTO-432)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04819100
Recruitment Status : Recruiting
First Posted : March 26, 2021
Last Update Posted : May 24, 2023
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company ( Loxo Oncology, Inc. )

Study Description
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Brief Summary:
The reason for this study is to see if the study drug, selpercatinib, compared to placebo is effective and safe in delaying cancer return in participants with early-stage non-small cell lung cancer (NSCLC), who have already had surgery or radiation. Participants who are assigned to placebo and stop the study drug because their disease comes back or gets worse have the option to potentially crossover to selpercatinib. Participation could last up to three years.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Selpercatinib Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 20, 2021
Estimated Primary Completion Date : August 31, 2028
Estimated Study Completion Date : November 30, 2032

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Selpercatinib
Selpercatinib administered orally.
 Drug: Selpercatinib
Administered orally.
Other Names:
  • LY3527723
  • LOXO-292
Placebo Comparator: Placebo
Placebo administered orally.
 Drug: Placebo
Administered orally.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Overall Survival (OS) [ Time Frame: Randomization to death from any cause (estimated as up to 9 years)] ]
    OS

  3. 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)

  4. 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

  5. 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

  6. Positive Predictive Value (PPV) of Rearranged during Transfection (RET) Tests from Investigator-Identified Laboratories with Respect to the Lilly-Designated RET Test [ Time Frame: Baseline ]
    PPV of RET Tests from Investigator-Identified Laboratories with Respect to the Lilly-Designated RET Test

  7. 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.

  8. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have histologically confirmed Stage IB, II, or IIIA NSCLC.
  • Must have an activating RET gene fusion in tumor based on polymerase chain reaction (PCR) or next generation sequencing (NGS).

  • Must have received definitive locoregional therapy with curative intent (surgery or radiotherapy) for Stage IB, II, or IIIA NSCLC.

    -- Must have undergone the available anti-cancer therapy (including chemotherapy or durvalumab) or not be suitable for it, based on the investigator's discretion.

  • Maximum time allowed between definitive therapy completion and randomization must be:

    • 10 weeks if no chemotherapy was administered
    • 26 weeks if adjuvant chemotherapy was administered
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Adequate hematologic, hepatic, and renal function.
  • Willingness of men and women of reproductive potential to observe conventional and highly effective birth control for the duration of the study and for at least 2 weeks after last dose of study drug.

Exclusion Criteria:

  • Additional oncogenic drivers in NSCLC, if known.
  • Evidence of small cell lung cancer.
  • Clinical or radiologic evidence of disease recurrence or progression following definitive therapy.
  • Known or suspected interstitial fibrosis or interstitial lung disease or history of (noninfectious) pneumonitis that required steroids.
  • Clinically significant active cardiovascular disease or history of myocardial infarction within six months prior to planned start of selpercatinib or prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) greater than 470 milliseconds.
  • Have known uncontrolled human immunodeficiency virus (HIV)-1/2 infection.
  • Have known active hepatitis B or C.
  • Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment.
  • Major surgery within 4 weeks prior to planned start of selpercatinib.
  • Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug.
  • Other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix or other in situ cancers or a malignancy diagnosed greater than or equal to two years previously and not currently active.
  • Pregnancy or lactation.
  • Prior treatment with a selective RET inhibitor (e.g. selpercatinib or pralsetinib).
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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Sponsors and Collaborators
Loxo Oncology, Inc.
Eli Lilly and Company
Investigators
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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
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Loxo Oncology, Inc.
ClinicalTrials.gov Identifier: NCT04819100    
Other Study ID Numbers: 18126
J2G-MC-JZJX ( Other Identifier: Eli Lilly and Company )
2020-005191-35 ( EudraCT Number )
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: May 24, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases