RET Inhibitor
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 Cancer*

NCT04194944 show modal icon
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
This clinical trial is being conducted globally.
Selpercatinib 160 mg is administered PO BID.
Carboplatin AUC 5 mg∙min/mL is administered intravenously (IV) Q3W.
Cisplatin 75 mg/m2 is administered IV Q3W.
Pemetrexed 500 mg/m2 is administered IV Q3W.
Pembrolizumab 200 mg is administered IV Q3W.
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.