A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

Korábbi kezelés

• 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.
• 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.
• Requiring chronic treatment with steroids.

Más betegség

• 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.
• Uncontrolled, disease related pericardial effusion or pleural effusion.
• History of interstitial lung disease or interstitial pneumonitis.
• Active autoimmune disease or any illness or treatment that could compromise the immune system.

Laborértékek

• 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.

Egyéb

• Additional validated oncogenic drivers in NSCLC if known.
• Symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or untreated spinal cord compression.
• Pregnancy or lactation.

• 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.