An observational study in RET-fusion Non Small Cell Lung Cancer, Lung Neoplasm and Carcinoma, Non-Small-Cell Lung, sponsored by Blueprint Medicines Corporation. Status unknown at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-10.
Sponsored by Blueprint Medicines Corporation · 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.
6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.
This study's planned enrollment of 279 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →Blueprint Medicines Corporation is the lead sponsor of 32 studies on the registry; 6 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 3 (21%) have results posted.
Counted across the registry records on this site, refreshed daily.
This study will include patients with locally advanced or metastatic RET-fusion positive non-small cell lung cancer (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:
Exclusion Criteria:
Patients with Non-Small Cell Lung Cancer (NSCLC) who received treatment with pralsetinib as part of the BLU-667-1101 (ARROW) study
Patients with Non-Small Cell Lung Cancer (NSCLC) that received best available therapy
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)
Time frame: Up to 12 years
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
Time frame: Up to 12 years
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
Time frame: Up to 12 years
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
Time frame: Up to 12 years
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
Time frame: Up to 12 years
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
Time frame: Up to 12 years
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
Time frame: Up to 12 years
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
Time frame: Up to 12 years
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
Time frame: Up to 12 years
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Blueprint Medicines Corporation