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

NCT04074993 | Unknown Phase 2

• 1 other identifier: NCC2019-0212
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  Objective response rate

  From Cycle1 Day 1 until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months. Tumor assessment will be performed at the end of cycle 2(every 2 cycles, each cycle is 28 days).

Study Arms (1)

Brigatinib

EXPERIMENTAL

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.

Drug: Brigatinib

Interventions

Brigatinib DRUG

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.

Brigatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant(or legally acceptable representative if applicable) provides written informed consent for the study
• Patients who have disease progression with prior one ALK-TKI treatment for inoperable Stage III (locally advanced) or metastatic ALK+ NSCLC.(Previous treatment only allowed one ALK-inhibitor) Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months since the last chemotherapy, radiotherapy, or chemoradiotherapy cycle.
• ALK rearrangement , as detected via the blood somatic mutation assay
• One prior ALK inhibitor therapy
• Have at least 1 measurable lesion per RECIST version 1.1
• Have Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Recovered from toxicities related to prior anticancer therapy to NCI CTCAE, version 5.0, Grade≤1(Note : Alopecia, sensory neuropathy Grade≤2, or other Grade≤2 AEs not constituting a safety risk based on Investigator's judgement are acceptable
• Have a life expectancy of ≥3 months
• Have adequate organ and hematologic function as determined by:
• ALT/AST≤2.5×ULN; ≤5×ULN is acceptable if liver metastases are present
• Total serum bilirubin≤1.5×ULN (\<3.0×ULN for patients with Gilbert syndrome)
• Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2, using the MDRD equation
• Absolute neutrophil count ≥1.5×109/L.
• Platelet count ≥75×109/L.
• Hemoglobin ≥9 g/dL.

You may not qualify if:

• Has received ALK-targeted TKI within 7 days before the first dose of study treatment(If clinically justified, 3 days wash-out period could be allowed).
• Has received radiotherapy within 14 days before the first dose of study treatment except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT). A 1-week washout is permitted for palliative radiation(≤2 weeks of radiotherapy) to non-CNS disease.
• Had major surgery within 28 days of the first dose of study treatment. Minor surgical procedures are allowed.
• Has symptomatic brain metastasis or leptomeningeal disease. Prior brain metastasis or leptomeningeal disease allowed if asymptomatic or stable symptoms that did not require an increased dose of corticosteroids to control symptoms within 7 days prior to study enrollment. If patients have neurological symptoms or signs due to CNS metastasis, patients need to complete whole brain radiation or stereotactic radiosurgery treatment before enrollment and be clinically stable.
• Has current spinal cord compression
• Other malignancy within 3 years, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, and ductal carcinoma in situ treated surgically with curative intent
• Any gastrointestinal (GI) disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post-major bowel resection
• Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:
• Myocardial infarction within 6 months before the first dose of brigatinib.
• Unstable angina within 6 months before first dose of brigatinib.
• Congestive heart failure within 6 months before first dose of brigatinib.
• History of clinically significant atrial arrhythmia (including clinically significant bradyarrhythmia).
• Any history of clinically significant ventricular arrhythmia.
• Has uncontrolled hypertension.
• Had a cerebrovascular accident or transient ischemic attack within 6 months before first dose brigatinib.

Sponsors & Collaborators

• JI-YOUN HAN: lead
• Seoul National University Hospital: collaborator
• Severance Hospital: collaborator
• Seoul National University Bundang Hospital: collaborator

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

brigatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 25, 2019
• First Posted: August 30, 2019
• Study Start: May 15, 2020
• Primary Completion: January 31, 2025
• Study Completion: March 31, 2025
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)