Background
Methods / design
Study design
Eligibility criteria
Key Inclusion Criteria | |
√ | Written informed consent obtained from the patient |
√ | Patients aged at least 20 years at the time of informed consent |
√ | Histologically or cytologically confirmed non-squamous non-small cell lung cancer |
√ | Confirmed ALK rearrangement using companion diagnostics |
√ | Stage IIIB, stage IIIC, stage IV, or postoperative relapse for which definitive radiotherapy is impossible |
√ | At least one measurable lesion based on RECIST v1.1 |
√ | No symptomatic brain metastases |
√ | No symptomatic superior vena cava syndrome |
√ | No spinal cord compression |
√ | Patients with non-squamous non-small cell lung cancer previously untreated with chemotherapy |
√ | The specified time period has elapsed since the treatment defined in protocol |
√ | ECOG performance status 0–1 |
√ | Adequate organ function |
Key Exclusion Criteria | |
√ | Presence of active double cancers (synchronous cancers and metachronous cancers with disease-free interval within 3 years) |
√ | Presence of active systemic infection or topical infection requiring surgical treatment |
√ | Presence of active hepatitis B or C |
√ | Pregnant or Lactating women |
√ | Men who do not intend to use contraception |
√ | Presence of symptomatic cerebrovascular diseases or past history of these within one year |
√ | Nausea, vomiting, or absorption impediments causing difficulty with administration of the trial drug |
√ | Presence of congestive heart failure and unstable angina or past history of myocardial infarction within one year |
√ | History of interstitial lung disease, drug-induced interstitial lung disease, and radiation pneumonitis requiring treatment by steroid |
√ | Patients with psychiatric disorder or mental symptoms |
√ | Calculated based on prednisone, requiring continuous full-body administration of high-dosage steroids over 10 mg/day or currently using other immunosuppressant drugs |
√ | History of hypersensitivity to brigatinib, carboplatin, pemetrexed, and any excipients of these drugs |
√ | Other patients determined unfit by an attending physician will also be excluded |