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 Cancer*
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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
*
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.
