WJOG 14720
- Conditions
- ntreated ALK-rearranged non-squamous non-small cell lung cancer
- Registration Number
- JPRN-jRCTs041210103
- Lead Sponsor
- Hirotsugu Kenmotsu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 110
1.Written informed consent obtained from the patient
2.Aged at least 20 years at the time of informed consent
3.Histologically or cytologically confirmed non-squamous non-small cell lung cancer
4.Confirmed ALK rearrangement by companion diagnostics
5.Stage IIIB, stage IIIC, stage IV, or postoperative relapse for which definitive radiotherapy is impossible
6.At least 1 measurable lesion based on RECIST v1.1
7.No symptomatic brain metastases
8.No symptomatic superior vena cava syndrome
9.No spinal cord compression
10.Patients with non-squamous non-small cell lung cancer previously untreated with chemotherapy
11.The specified time period has elapsed since the treatment defined in protocol
12.ECOG PS 0-1
13.Adequate organ function
1.Presence of active double cancers
2.Presence of active systemic infection or topical infection requiring surgical treatment
3.Presence of active hepatitis B or C
4.Pregnancy or Lactation in women
5.Men who do not intend to use contraception
6.Presence of symptomatic cerebrovascular diseases or past history of these within 1 year
7.Nausea, vomiting, or absorption impediments causing difficulty with administration of the trial drug
8.Presence of congestive heart failure and unstable angina or past history of myocardial infarction within 1 year
9.History of interstitial lung disease, drug-induced interstitial lung disease, and radiation pneumonitis requiring steroid treatment
10.Presence of psychiatric disorder or mental symptoms
11.Calculated based on prednisone, requiring continuous full-body administration of high-dosage steroids over 10 mg/day or currently using other immunosuppressant drugs
12.History of hypersensitivity to brigatinib, carboplatin, pemetrexed and any excipients of these drugs
13.Other patients determined unfit by an attending physician will also be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival
- Secondary Outcome Measures
Name Time Method Objective response rate, Overall survival, proportion of adverse events, evaluation of tumor-derived DNA with gene alteration from plasma specimens