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PIPELINE > TRIAL OVERVIEW

NCT04194944; LIBRETTO-431

NSCLC

Trial Information
Molecule Overview
RET Inhibitor
Selpercatinib
Phase
3
Not Enrolling
A Multicenter, Randomized, Open-Label, Phase 3 Trial Comparing Selpercatinib to Platinum-Based and Pemetrexed Therapy With or Without Pembrolizumab as Initial Treatment of Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancera
Related Resources:
Molecule Overview Trial Enrollment
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Key Inclusion Criteria
  • Stage IIIB-IIIC or stage IV nonsquamous non-small cell lung cancer (NSCLC) 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 organ function
  • Patients with reproductive potential must use a highly effective contraceptive method for the duration of treatment and for 6 months after
  • Able to swallow capsules
Key Exclusion Criteria
  • Additional validated oncogenic drivers in NSCLC, if known
  • Previously received systemic therapy for metastatic disease
    • Treatment (chemotherapy, immunotherapy, or biological therapy) in the adjuvant/neoadjuvant setting is permitted if completed at least 6 months prior to randomization
  • Major surgery within 3 weeks prior to planned start of treatment
  • Radiotherapy for palliation within 1 week of the first dose of study treatment or within 6 months prior to the first dose of study treatment if more than 30 Gy to the lung
  • Symptomatic central nervous system metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression
  • Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of treatment
  • Prolongation of the QTcF interval of >470 ms 
  • Other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix, or malignancy diagnosed ≥2 years previously and not currently active
  • Uncontrolled, disease-related pericardial effusion or pleural effusion
  • Receiving pembrolizumab and have a history of interstitial lung disease or interstitial pneumonitis, or have an active autoimmune disease or any illness or treatment that could compromise the immune system
  • Active, uncontrolled systemic bacterial, viral, or fungal infections, or serious ongoing intercurrent illness such as hypertension or diabetes, despite optimal treatment
a
This clinical trial is being conducted globally.
b
Administered at 160 mg orally BID.
c
Carboplatin AUC 5 mg∙min/mL (maximum dose at 750 mg) is administered intravenously Q3W.
d
Administered at 75 mg/m2 intravenously Q3W.
e
Administered at 500 mg/m2 intravenously Q3W.
f
Administered at 200 mg intravenously Q3W.
g
The primary endpoints are PFS in patients receiving pembrolizumab and PFS in all patients.
For information on trial enrollment, locations, and more, call 1-800-545-5979.
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or visit www.clinicaltrials.gov for more information on this trial