Phase II Study of Brigatinib for ALK-positive advanced non-small cell lung cancer with brain metastases

JRCT ID: jRCTs071230025

Registered date:20/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: ALK-positive advanced non-small cell lung cancer with brain metastases
• Date of first enrollment: 13/11/2023
• Target sample size: 22
• Study type: Interventional
• Intervention(s): Brigatinib90 mg once daily for 7 days.After that, 180 mg once a day for consecutive days until PD is achieved.

Outcome(s)

• Primary Outcome: Response rate in brain metastases (modified RECIST criteria)

Secondary Outcome

progression-free survival for brain metastases
progression-free survival rate for brain metastases
time to local brain therapy
whether and how to provide local therapy to brain metastases after exacerbation of brain metastases
response rate other than brain metastases
progression-free survival other than brain metastases
systemic response rate
systemic progression-free survival
safety

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)A histologically or cytologically confirmed diagnosis of non-small cell lung cancer.
2)Stage IV, postoperative recurrence or recurrence after radical irradiation of the trunk more than 24 weeks after the last irradiation date.
3)The patient has been diagnosed as ALK fusion-positive by the companion diagnostic agent brigatinib.
4)No history of ALK inhibitor administration (patients who received alectinib as adjuvant therapy can be enrolled if they have not had a recurrence during alectinib treatment and more than 180 days have passed since the last alectinib administration).
5)The applicant is at least 18 years of age on the date consent is obtained.
6)Performance status (PS) is 0 to 2 according to ECOG criteria (PS must be documented in the medical record).
7)Brain metastases with the longest diameter more than twice the slice width and more than 5 mm on head MRI within 28 days prior to registration. The presence or absence of brain metastasis symptoms is not required.
8)The presence or absence of measurable lesions other than brain metastases is not required.
9)No severe impairment of major organs (bone marrow, heart, lungs, liver, kidney, etc.)
10)Patients who can take oral medications.
11)Patients expected to survive at least 3 months.
12)If the prior treatments or procedures were performed prior to enrollment, the specified period of time since completion has elapsed.
13)Written consent to participate in this study has been obtained from the patient.

Exclude criteria

1)Brain metastases requiring urgent radiotherapy or surgical resection.
2)Patients with interstitial lung disease (drug-induced lung injury and radiation pneumonitis are eligible for registration if they have improved).
3)Symptomatic congestive heart failure, unstable angina, myocardial infarction, or symptomatic cerebrovascular disease within 3 months prior to enrollment.
4)Poorly controlled hypertension.
5)Patients with poorly controlled diabetes mellitus.
6)Has an infection requiring systemic treatment.
7)Have active hepatitis B or hepatitis C
8)Active overlapping carcinoma.
9)Women who are pregnant. Lactating women. Women who are unwilling to use contraception during this study.
10)Men who are unwilling to use contraception during this study.
11)The patient has a psychiatric disorder or psychiatric symptoms that interfere with his/her daily life and makes participation in the study difficult.
12)Other patients who are deemed inappropriate for the conduct of this study by the physician in charge, etc.

Related Information

• Primary Sponsor: Naoki Katsuhiko
• Source(s) of Monetary Support: Takeda Pharmaceutical Co., Ltd