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

  • STATUS
    Recruiting
  • End date
    Nov 30, 2032
  • participants needed
    170
  • sponsor
    Loxo Oncology, Inc.
Updated on 23 July 2022
RET
durvalumab
cancer chemotherapy
adjuvant chemotherapy
kidney function test
lung carcinoma

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.

Details
Condition Carcinoma, Non-Small-Cell Lung
Treatment Placebo, Selpercatinib
Clinical Study IdentifierNCT04819100
SponsorLoxo Oncology, Inc.
Last Modified on23 July 2022

Eligibility

Yes No Not Sure

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
Must have completely recovered from definitive therapy (surgery or radiotherapy) as well as adjuvant therapy at the time of randomization
Maximum time allowed between definitive therapy completion and randomization must be
weeks if no chemotherapy was administered
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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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