UnknownNot applicableNCT04697446

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

StatusUnknown
PhaseNot applicable
U.S. locations3
SponsorBlueprint Medicines Corporation
01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Blueprint Medicines Corporation
Interventions being studied
Not specified
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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