External Control, Observational, Retrospective Study Comparing Pralsetinib to Best Available Therapy in Patients With RET-Fusion Positive NSCLC

Blueprint Medicines

Status: Unknown

Conditions: Neoplasms by Site; Neoplasms, Nerve Tissue; Carcinoma; Head and Neck Neoplasms; Lung Neoplasm; Neoplasms, Germ Cell and Embryonal; Respiratory Tract Neoplasms; RET-fusion Non Small Cell Lung Cancer; Neoplasms by Histologic Type; Carcinoma, Bronchogenic; Thoracic Neoplasms; Lung Diseases; Neoplasms; Respiratory Tract Diseases; Carcinoma, Non-Small-Cell Lung; Bronchial Diseases; Metastatic Non Small Cell Lung Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT04697446

BLU-667-2404

Details and patient eligibility

About

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.

Enrollment: 279 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

279 participants in 2 patient groups

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

External Control Group

Description:

Patients with Non-Small Cell Lung Cancer (NSCLC) that received best available therapy