Neoplasms Clinical Trial
Official title:
An External Control, Observational, Retrospective Study Assessing the Effect of Pralsetinib Compared With Best Available Therapy for Patients With RET-Fusion Positive Advanced Non-Small Cell Lung Cancer
Verified date | August 2021 |
Source | Blueprint Medicines Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 279 |
Est. completion date | October 31, 2021 |
Est. primary completion date | October 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | University Hospital Center of Toulouse - Larrey Hospital | Toulouse | |
Switzerland | Lucerne Cantonal Hospital | Lucerne | |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Blueprint Medicines Corporation | Analysis Group, Inc. |
United States, France, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparative evaluation of real-world response rate (rwORR) between patients receiving best available therapy versus pralsetinib | rwORR, defined as the proportion of patients with clinician-assess complete response (CR) or partial response (PR) | Up to 12 years | |
Secondary | Comparative evaluation between patients receiving best available therapy versus pralsetinib of Overall survival (OS) | OS, defined as time from initiation of a given line of therapy to death from any cause | Up to 12 years | |
Secondary | Comparative evaluation between patients receiving best available therapy versus pralsetinib of Real-world duration of response (rwDOR) | rwDOR, defined as the duration of time from the first documented clinician-assessed response to the first documented clinician-assessed progressive disease or death due to any cause within 30 days of the last radiological exam, for each line of treatment | Up to 12 years | |
Secondary | Comparative evaluation between patients receiving best available therapy versus pralsetinib of Real-world disease control rate (rwDCR) | rwDCR, defined as proportion of patients with clinician-assessed complete response, partial response, or stable disease | Up to 12 years | |
Secondary | Comparative evaluation between patients receiving best available therapy versus pralsetinib of Real-world clinical benefit rate (rwCBR) | rwCBR, defined as proportion of patients who had documented clinician-assessed complete response or partial response, or stable disease lasting at least 16 weeks | Up to 12 years | |
Secondary | Comparative evaluation between patients receiving best available therapy versus pralsetinib of Real-world progression-free survival (rwPFS) | rwPFS, defined as time from initiation of line of therapy to clinician-assessed disease progression or death from any cause, whichever occurs first | Up to 12 years | |
Secondary | Comparative evaluation between patients receiving best available therapy versus pralsetinib of Duration of treatment (DOT) | DOT, defined as time from initiation of line of systemic treatment to discontinuation of same line of treatment for any reason | Up to 12 years | |
Secondary | Comparative evaluation between patients receiving best available therapy versus pralsetinib of Time to next treatment line (TtNTL) | TtNTL, defined as the time from initiation of line of systemic treatment to the initiation of the next line of treatment | Up to 12 years | |
Secondary | To characterize the safety profile and conduct comparative evaluation of safety between patients receiving best available care vs. pralsetinib | Adverse events (AEs) that result in treatment modification or discontinuation, hospitalization, or death according to evaluation of responsible physician | Up to 12 years |
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