External Control, Observational, Retrospective Study Comparing Pralsetinib to Best Available Therapy in Patients With RET-Fusion Positive NSCLC
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.
Checked against the public recordLast updated Aug 10, 2021 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- Blueprint Medicines Corporation
- Interventions being studied
- Not specified
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * 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 Criteria: * 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Memorial Sloan Kettering Cancer CenterNew York, New York
- University Hospital Center of Toulouse - Larrey HospitalToulouse
- Lucerne Cantonal HospitalLucerne
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 10, 2021. Always confirm current availability with the study team.