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RecruitingLast updated: 19 February 2024

LIBRETTO-432: This trial is trying to determine whether a new targeted cancer drug (called selpercatinib) can safely and effectively delay non-small cell lung cancers from returning in non-small cell lung cancer patients who have already received surgery or radiationA 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

Clinical summary

Summary

Eligible participants will be randomised to receive oral selpercatinib or a placebo. Participants assigned to receive a placebo will have the option to crossover to selpercatinib if their disease comes back or gets worse. Participation could last for up to three years.

Conditions

This trial is treating patients with non-small cell lung cancer

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

III

Trial Acronym

LIBRETTO-432

More information

Trial Identifiers

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Trial sponsor

Loxo Oncology, Inc.

Scientific Title

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

Eligibility

Inclusion

  • 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), next generation sequencing (NGS), or another molecular test per sponsor's approval.
  • 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

  • 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).

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

This trial is operating as a teletrial at one or more locations. Learn more about teletrials.

Recruiting hospitals

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