Untreated ALK-rearranged non-squamous non-small cell lung cancer
Conditions
Interventions
The treatment of this study is followed
Group A
Brigatinib at a dose of 180mg once daily (with a 7-day lead-in period at 90mg)
Group B
Brigatinib at a dose of 180mg once daily (with a 7-day lead-in p
Sponsors
Yamamoto Nobuyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, Overall survival, proportion of adverse events, evaluation of tumor-derived DNA with gene alteration from plasma specimens | — |
Contacts
Public ContactKouji Takeda
West Japan Oncology Group
Outcome results
None listed