A Phase 3 Trial Comparing Selpercatinib to Platinum-Based and Pemetrexed Therapy with or without Pembrolizumab (LIBRETTO-431)

Phase 1

• Conditions: Male or female patients with advanced, treatment-naïve RET Fusion-Positive Non-Squamous NSCLC; MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-001979-36-DE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-19
• Last Update Posted: 31 July 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 250

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
- Measurable disease as determined by RECIST 1.1 by the investigator
- ECOG performance status of 0-2
- Adequate hematologic, hepatic and renal function
- Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 6 months after
- Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 125

Exclusion Criteria

- Additional validated oncogenic drivers in NSCLC if known
- Prior systemic therapy for metastatic disease
- Major surgery (excluding placement of vascular access) within 3 weeks prior to planned start of selpercatinib
- Radiotherapy for palliation or any radiotherapy 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 CNS 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 selpercatinib or prolongation of the QT interval corrected for heart rate using Fridericia’s formula (QTcF) > 470 msec
- Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment. Screening for chronic conditions is not required
- Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug
- Require concomitant use of medications known to cause QTc prolongation
- Known hypersensitivity to any of the excipients of the study drugs
- Pregnancy or lactation
- Active second malignancy
- Uncontrolled, disease-related, pericardial effusion or pleural effusion - requiring chronic treatment with steroids
- Has known active Hepatitis B or C.

Exclusion Criteria for patients receiving pembrolizumab
- History of interstitial lung disease or interstitial pneumonitis
- Active autoimmune disease or any illness or treatment that could compromise the immune system

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified