Status:
UNKNOWN
External Control, Observational, Retrospective Study Comparing Pralsetinib to Best Available Therapy in Patients With RET-Fusion Positive NSCLC
Lead Sponsor:
Blueprint Medicines Corporation
Collaborating Sponsors:
Analysis Group, Inc.
Conditions:
RET-fusion Non Small Cell Lung Cancer
Lung Neoplasm
Eligibility:
All Genders
18+ years
Brief Summary
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 advance...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2021
Estimated Enrollment :
279 Patients enrolled
Trial Details
Trial ID
NCT04697446
Start Date
December 1 2020
End Date
October 31 2021
Last Update
August 10 2021
Active Locations (3)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
2
University Hospital Center of Toulouse - Larrey Hospital
Toulouse, France, 31300
3
Lucerne Cantonal Hospital
Lucerne, Switzerland, 6000