Brigatinib in ALK-positive NSCLC identified via Blood-based Assays
- Conditions
- Neoplasms
- Registration Number
- KCT0004234
- Lead Sponsor
- ational Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 35
1. The participant(or legally acceptable representative if
applicable) provides written informed consent for the study 2. 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. 3. ALK rearrangement , as detected via the blood somatic mutation assay
4. One prior ALK inhibitor therapy 5. Have at least 1 measurable lesion per
RECIST version 1.1 6. Have Eastern Cooperative Oncology Group (ECOG) performance
status 0-2 7. 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 8. Have a life expectancy of =3 months 9. Have adequate
organ and hematologic function as determined by: a) ALT/AST=2.5×ULN; =5×ULN is
acceptable if liver metastases are present b) Total serum bilirubin=1.5×ULN
(<3.0×ULN for patients with Gilbert syndrome) c) Estimated glomerular
filtration rate (eGFR) =30 mL/min/1.73 m2, using the MDRD equation d) Absolute
neutrophil count =1.5×109/L. e) Platelet count =75×109/L. f) Hemoglobin =9 g/dL.
g) Serum lipase =1.5×ULN 10. For female patients of childbearing potential,
have a negative pregnancy test(urine or serum) documented =3 days before start
of study medication. non-childbearing potential which is defined as : - female
patient=45 years of age and has not had menses for greater than 1 year - a
female who is status post hysterectomy, oophorectomy 11. Female patients of
childbearing potential and male patients with partners of childbearing potential
must agree to use 2 effective methods of contraception, at the same time, from
the time of signing the informed consent through 4 months after the last dose of
study drug, or agree to completely abstain from heterosexual intercourseHave the
willingness and ability to comply with scheduled visit and study procedures.
Male patients, even if surgically sterilized (i.e., status post-vasectomy),
who: • Agree to practice effective barrier contraception during the entire study
treatment period and through 4 months after the last dose of study drug, or
• Agree to completely abstain from heterosexual intercourse 12. Have the
willingness and ability to comply with scheduled visit and study procedures.
13. Be = 18 years of age
1. 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). 2. 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. 3. Had major
surgery within 28 days of the first dose of study treatment. Minor surgical
procedures are allowed. 4. 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. 5. Has current spinal cord
compression 6. 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 7. Any gastrointestinal (GI)
disorder that may affect absorption of oral medications, such as malabsorption
syndrome or status post-major bowel resection 8. Have significant, uncontrolled,
or active cardiovascular disease, specifically including, but not restricted to:
a) Myocardial infarction within 6 months before the first dose of brigatinib.
b) Unstable angina within 6 months before first dose of brigatinib. c)
Congestive heart failure within 6 months before first dose of brigatinib. d)
History of clinically significant atrial arrhythmia (including clinically
significant bradyarrhythmia). e) Any history of clinically significant
ventricular arrhythmia. 9. Has uncontrolled hypertension. 10. Had a
cerebrovascular accident or transient ischemic attack within 6 months before
first dose brigatinib. 11. Have a history or the presence of pulmonary
interstitial disease, drug-related pneumonitis, or radiation-related pneumonitis
12. Active infection requiring systemic therapy. 13. Known history of HIV
infection. 14. Has a known or suspected hypersensitivity to brigatinib or its
excipients. 15. Female patients who are both lactating and breastfeeding or have
a positive serum pregnancy test during the screening period or a positive urine
pregnancy test on Day 1 before first dose of study drug (if applicable).
16. Have any condition or illness that, in the opinion of the investigator,
would compromise 17. patient safety or interfere with the evaluation of
brigatinib 18. Received systemic treatment with strong cytochrome P-450 (CYP)3A
inhibitors, strong CYP3A inducers, or moderate CYP3A inducers within 14 days
before enrollment.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate
- Secondary Outcome Measures
Name Time Method progression free survival;overall survival