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

NCT ID: NCT04697446

Last Updated: 2021-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 279 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-10-31

Brief Summary

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

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients from the BLU-667-1101 (ARROW) study

Patients with Non-Small Cell Lung Cancer (NSCLC) who received treatment with pralsetinib as part of the BLU-667-1101 (ARROW) study

No interventions assigned to this group

External Control Group

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Analysis Group, Inc.

INDUSTRY

Sponsor Role: collaborator

Blueprint Medicines Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University Hospital Center of Toulouse - Larrey Hospital

Toulouse, , France

Lucerne Cantonal Hospital

Lucerne, , Switzerland

Countries

United States; France; Switzerland

Other Identifiers

BLU-667-2404

Identifier Type: -

Identifier Source: org_study_id