NCT04074993

Brigatinib in ALK-positive NSCLC Identified Via Blood-based Assays

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: JI-YOUN HAN · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is single-arm, open-label study design. Patients will receive brigatinib until disease progression, unacceptable toxicity, withdrawal of consent, of death.

Detailed description

Based on the clinical efficacy of ALK inhibitors in ALK+NSCLC, NCCN guidelines recommend ALK molecular testing of lung cancer patients, to select patients for ALK-targeted therapy. However, molecular testing via tissue biopsy cannot always be performed on NSCLC patients, potentially limiting access of effective treatment to the subset of patients who are able to undergo current testing procedures that utilize tissue biopsies. Obtaining an adequate tissue biopsy specimen for NSCLC presents a number of challenges. In particular, the method for diagnosis of lung cancer depends on the location, size, and type of suspected lung cancer, and the presence or absence of metastases. Common procedures for centrally located tumors include bronchoscopy and sputum cytology, which frequently yield insufficient tumor tissue for comprehensive mutation testing. In addition, 75% of patients are diagnosed with late-stage disease and often present with multiple comorbidities. Biopsies in these patients can lead to complications such as pneumothorax, hemoptysis, other bleeding complications, and cardiopulmonary decompensation. As a result of these factors, a physician treating a patient who presents with a significant burden of disease as well as significant comorbidities may rightly consider whether it is in the best interest of the patient to undergo a risky and potentially unsuccessful procedure. Thus, there exists a major unmet clinical need for testing procedures that do not require tumor tissue. The purpose of this phase II study is to assess the efficacy of brigatinib in patients with advanced NSCLC harboring ALK rearrangement that are selected using predictive biomarkers identified via blood-based assays.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Brigatinib	Subject will be treated with Brigatinib 90mg/day for 1 week and then 180mg/day PO daily. A Cycle will be defined as 28-days. Treatment will be continued until disease progression or unacceptable toxicity.

Timeline

• Start date: 2020-05-15
• Primary completion: 2025-01-31
• Completion: 2025-03-31
• First posted: 2019-08-30
• Last updated: 2023-09-28

Locations

1 site across 1 country: South Korea