A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer (LIBRETTO-431)

  • STATUS
    Recruiting
  • End date
    Aug 18, 2025
  • participants needed
    250
  • sponsor
    Loxo Oncology, Inc.
Updated on 21 July 2022
progressive disease
pemetrexed
carboplatin
pembrolizumab
RET
kidney function test
lung carcinoma
squamous non-small cell lung cancer
non-squamous non-small cell lung cancer

Summary

The reason for this study is to see if the study drug selpercatinib compared to a standard treatment is effective and safe in participants with rearranged during transfection (RET) fusion-positive non-squamous non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.

Details
Condition Non-Small Cell Lung Cancer
Treatment cisplatin, carboplatin, Pembrolizumab, Pemetrexed, Selpercatinib
Clinical Study IdentifierNCT04194944
SponsorLoxo Oncology, Inc.
Last Modified on21 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically or cytologically confirmed, Stage IIIB-IIIC or Stage IV non-squamous NSCLC that is not suitable for radical surgery or radiation therapy
A RET gene fusion in tumor and/or blood from a qualified laboratory
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
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 treatment and for 6 months after
Ability to swallow capsules

Exclusion Criteria

Additional validated oncogenic drivers in NSCLC if known
Prior systemic therapy for metastatic disease. Treatment (chemotherapy, immunotherapy, or biological therapy) in the adjuvant/neoadjuvant setting is permitted if it was completed at least 6 months prior to randomization
Major surgery within 3 weeks prior to planned start of selpercatinib
Radiotherapy for palliation within 1 week of the first dose of study treatment or any radiotherapy within 6 months prior to the first dose of study treatment if more than 30 Gy to the lung
Symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or untreated spinal cord compression
Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of selpercatinib or prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) > 470 milliseconds
Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment
Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug
Pregnancy or lactation
Other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix or other in situ cancers or a malignancy diagnosed ≥2 years previously and not currently active
Uncontrolled, disease related pericardial effusion or pleural effusion
Requiring chronic treatment with steroids
Exclusion Criteria for Participants Receiving Pembrolizumab
History of interstitial lung disease or interstitial pneumonitis
Active autoimmune disease or any illness or treatment that could compromise the immune system
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