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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Aug 10, 2021 · Source: ClinicalTrials.gov
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Observational
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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.