External Control, Observational, Retrospective Study Comparing Pralsetinib to Best Available Therapy in Patients With RET-Fusion Positive NSCLC

Status unconfirmed

Conditions studied: RET-fusion Non Small Cell Lung Cancer, Lung Neoplasm, Carcinoma, Non-Small-Cell Lung, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases, Carcinoma, Bronchogenic, Bronchial Diseases, Head and Neck Neoplasms, Carcinoma, Neoplasms by Histologic Type, Neoplasms, Germ Cell and Embryonal, Neoplasms, Nerve Tissue, Metastatic Non Small Cell Lung Cancer

In brief

This is an external control, observational, retrospective study designed to compare clinical outcomes for pralsetinib compared with best available therapy for patients with RET-fusion positive advanced NSCLC.

Key facts

Study ID

NCT04697446

Run by

Blueprint Medicines Corporation

People needed

279

Starts

2020-12-01

Expected to finish

2021-10-31

Last updated by the study team

2021-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have a diagnosis of locally advanced (non-resectable) or metastatic RET-fusion positive NSCLC
• Must have received at least one line of systemic therapy for locally advanced (non-resectable) or metastatic RET-fusion positive NSCLC, which may include regimens containing:
• Chemotherapy, e.g., regimens containing platinum doublet-based therapy (carboplatin, cisplatin)
• Chemotherapy in combination with other drugs will be assessed, e.g., in combination with pemetrexed, immune checkpoint inhibitors (pembrolizumab), bevacizumab
• Ramucirumab in combination with docetaxel
• Immune checkpoint inhibitors, e.g., pembrolizumab, nivolumab, and atezolizumab
• MKIs, e.g., cabozantinib, alectinib, vandetanib, sunitinib, and nintedanib
• Must be aged ≥18 years of age at the initiation of first systemic line of therapy
• Must have availabile of performance status (e.g., Eastern Cooperative Oncology Group [ECOG] score or Karnofsky score)
• Must have an index date at least 3 months prior to the start of data collection (in order to include patients with at least 3 months of follow-up after index date), unless date of death occurred less than three months from index date
• Must have an approved waiver of informed consent or signed informed consent for participation in the retrospective chart review study, as applicable

You may not qualify if…

• Known primary driver alteration other than RET (e.g., targetable mutation in EGFR, ALK, ROS1, or BRAF)
• History of other malignancy, other than non-melanoma skin cancer, within 1 year prior to initiation of first systemic therapy
• Received pralsetinib as the first line of systemic therapy for RET-fusion positive NSCLC, or prior to initiation of first systemic therapy

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University Hospital Center of Toulouse - Larrey Hospital — Toulouse, France
• Lucerne Cantonal Hospital — Lucerne, Switzerland

Full record on ClinicalTrials.gov

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