IBRETTO-431: A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing Selpercatinib to Platinum-Pemetrexed Chemotherapy Plus Investigator*s Choice of Pembrolizumab in Patients with Advanced, Treatment-Naïve RET Fusion-Positive Non-Small Cell Lung Cancer
- Conditions
- Oncology- LungLung CancerNon small cell Lung Cancer
- Registration Number
- NL-OMON52946
- Lead Sponsor
- Eli Lilly
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 7
- Histologically 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
- 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 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 strong CYP3A4 inhibitors or inducers, proton pump
inhibitors, or medications known to cause QTc prolongation
- Known hypersensitivity to any of the excipients of the study drugs
- Pregnancy or lactation
- Active second malignancy
- Symptomatic ascites or pleural effusion - requiring chronic treatment with
steroids
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Objectives<br /><br><br /><br>To compare PFS of selpercatinib and platinum-based (carboplatin or cisplatin)<br /><br>and pemetrexed therapy with or without pembrolizumab in patients with advanced<br /><br>or metastatic RET fusion-positive NSCLC<br /><br><br /><br>Endpoints<br /><br><br /><br>PFS per RECIST 1.1 by BICR</p><br>
- Secondary Outcome Measures
Name Time Method