Clinical trial · Observational
External Control, Observational, Retrospective Study Comparing Pralsetinib to Best Available Therapy in Patients With RET-Fusion Positive NSCLC
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
NCT04697446CI-TRIAL-00053178unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (17)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bronchial Diseases | — | UNRESOLVED | — |
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Carcinoma, Bronchogenic | Bronchogenic Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Lung Diseases | — | UNRESOLVED | — |
| Lung Neoplasm | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Metastatic Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Neoplasms by Histologic Type |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Patients from the BLU-667-1101 (ARROW) study
- description
- Patients with Non-Small Cell Lung Cancer (NSCLC) who received treatment with pralsetinib as part of the BLU-667-1101 (ARROW) study
- label
- External Control Group
- description
- Patients with Non-Small Cell Lung Cancer (NSCLC) that received best available therapy
Primary outcomes (1)
- measure
- Comparative evaluation of real-world response rate (rwORR) between patients receiving best available therapy versus pralsetinib
- timeFrame
- Up to 12 years
- description
- rwORR, defined as the proportion of patients with clinician-assess complete response (CR) or partial response (PR)
Secondary outcomes (8)
- measure
- Comparative evaluation between patients receiving best available therapy versus pralsetinib of Overall survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.