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Clinical Trials List

Protocol Number2002

NCT Number(ClinicalTrials.gov Identfier)NCT03535740

2019-01-01 - 2021-05-20

Phase II

Recruiting4

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

Brigatinib in Patients With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non–Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib

Trial Applicant

Pharmaceutical Research Associates Taiwan Inc.
Sponsor

Ariad Pharmaceuticals
Trial scale

Multi-Regional Multi-Center
Update

2025/08/20

Investigators and Locations

Principal Investigator Te-Chun Hsia 無

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG 無

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林聖皓無

CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Te-Chun Hsia 未分科

China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator Wu-Chou Su 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

ALK-positive Advanced NSCLC

Objectives

The primary purpose of this study is to determine the efficacy of brigatinib by confirmed objective response rate (ORR) by response evaluation criteria in solid tumors (Response Evaluation Criteria in Solid Tumors [RECIST]), in participants with ALK+ locally advanced or metastatic NSCLC whose disease has progressed on therapy with alectinib or ceritinib.

Test Drug

Brigatinib

Active Ingredient

Brigatinib

Dosage Form

film coated tablets

Dosage

30,90,180 mg per film coated tablets

Endpoints

Primary Outcome Measures:
1. Confirmed Objective Response Rate (ORR) Using RECIST v1.1 as Assessed by the Independent Review Committee (IRC.

Secondary Outcome Measures :
1. Confirmed ORR Using RECIST v1.1 as Assessed by the Investigator.
2. Duration of Response (DOR) as Assessed by the Investigator and IRC.
3. Progression-Free Survival (PFS) as Assessed by the Investigator and IRC.
4. Disease Control Rate (DCR) as Assessed by the Investigator and IRC.
5. Time to Response as Assessed by the Investigator and IRC.
6. Confirmed Intracranial Objective Response Rate (iORR) in Participants With Brain Metastases at Baseline, as Assessed by the IRC.
7. Duration of Intracranial Response in Participants With Brain Metastases at Baseline, as Assessed by the IRC.
8. Intracranial Progression-Free Survival (iPFS) in Participants With Brain Metastases at Baseline, as Assessed by the IRC.
9. Overall Survival (OS).
10. Number of Participants With One or More Treatment-emergent Adverse Event (TEAE).
11. Health-Related Quality of Life (HRQOL) from European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score.
12. HRQOL from EORTC QLQ- Lung Cancer (LC) 13.

Inclution Criteria

1. Have histologically or cytologically confirmed stage IIIB (locally advanced or recurrent and not a participant for curative therapy) or stage IV non-small-cell lung cancer (NSCLC).
2. Must meet both of the following 2 criteria:
a. Have documentation of anaplastic lymphoma kinase (ALK) rearrangement by a positive result from any laboratory test® approved by the food and drug administration (FDA) or Have documented ALK rearrangement by a different test (non-FDA-approved local lab tests) and have provided tumor sample to the central laboratory. (Note: Central laboratory ALK rearrangement testing results are not required to be obtained before randomization.)
b. Had been on any one of the ALK tyrosine kinase inhibitor (TKIs) (alectinib, ceritinib, crizotinib) for at least 12 weeks before progression.
3. Had progressive disease (PD) while on alectinib or ceritinib
4. Had alectinib or ceritinib as the most recent ALK inhibitor therapy.
5. Have at least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator.
6. Had recovered from toxicities related to prior anticancer therapy to national cancer institute common terminology criteria for adverse events (NCI CTCAE), version 4.03, Grade <=1. (Note: Treatment-related alopecia or peripheral neuropathy that are Grade >1 are allowed if deemed irreversible.) and have adequate major organ functions.
7. Have a life expectancy of ≥3 months.

Exclusion Criteria

1. Had received any prior ALK-targeted TKI other than crizotinib, alectinib, or ceritinib.
2. Had received both alectinib and ceritinib.
3. Had previously received more than 3 regimens of systemic anticancer therapy for locally advanced or metastatic disease.
4. Had symptomatic brain metastasis (parenchymal or leptomeningeal). Participants with asymptomatic brain metastasis or who have stable symptoms that did not require an increased dose of corticosteroids to control symptoms in the past 7 days before the first dose of brigatinib may be enrolled.
5. Had current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Participants with leptomeningeal disease and without cord compression are allowed.
6. Had a cerebrovascular accident or transient ischemic attack within 6 months before first dose of brigatinib.
7. Had an ongoing or active infection, including, but not limited to, the requirement for intravenous antibiotics.
8. Had malabsorption syndrome or other gastrointestinal (GI) illness that could affect oral absorption of brigatinib.

The Estimated Number of Participants

Taiwan

8 participants
Global

103 participants