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Closed (no longer recruiting)Last updated: 20 February 2024

LIBRETTO-431: This phase III trial is comparing a new oral therapy (Selpercatinib) with a standard treatment in patients with advanced non-small cell lung cancerA Multicenter, Randomized, Open-Label, Phase 3 Trial Comparing LOXO-292 to Platinum-Based and Pemetrexed Therapy With or Without Pembrolizumab as Initial Treatment of Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

Clinical summary

Summary

Eligible patients will be randomised to receive the experimental treatment (Selpercatinib, administered orally) or intravenous Pemetrexed (plus the investigator's discretion of carboplatin or cisplatin) with or without Pembrolizumab.

Conditions

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

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

III

Trial Acronym

LIBRETTO-431

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Eli Lilly and Company

Scientific Title

A Multicenter, Randomized, Open-Label, Phase 3 Trial Comparing LOXO-292 to Platinum-Based and Pemetrexed Therapy With or Without Pembrolizumab as Initial Treatment of Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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