ALK-positive Advanced NSCLC
Conditions
Interventions
investigational material(s)
Generic name etc : Brigatinib
INN of investigational material : Brigatinib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigatio
Sponsors
Takeda Pharmaceutical Company Limited
Ariad Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have histologically or cytologically confirmed stage IIIB (locally advanced or recurrent and not a participant for curative therapy) or stage IV non-small-cell lung cancer (NSCLC). 2. Must meet both of the following 2 criteria: - Have documentation of anaplastic lymphoma kinase (ALK) rearrangement by a positive result from any laboratory test approved by the food and drug administration (FDA) or Have documented ALK rearrangement by a different test (non- FDA-approved local lab tests) and have provided tumor sample to the central laboratory. (Note: Central laboratory ALK rearrangement testing results are not required to be obtained before randomization.) - Had been on any one of the ALK tyrosine kinase inhibitor (TKIs) (alectinib, ceritinib, crizotinib) for at least 12 weeks before progression. 3. Had progressive disease (PD) while on alectinib or ceritinib 4. Had alectinib or ceritinib as the most recent ALK inhibitor therapy. 5. Have at least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator. 6. Had recovered from toxicities related to prior anticancer therapy to national cancer institute common terminology criteria for adverse events (NCI CTCAE), version 4.03, Grade 1 are allowed if deemed irreversible.) and have adequate major organ functions. 7. Have a life expectancy of >=3 months.
Exclusion criteria
Exclusion criteria: 1. Had received any prior ALK-targeted TKI other than crizotinib, alectinib,or ceritinib. 2. Had received both alectinib and ceritinib. 3. Had previously received more than 3 regimens of systemic anticancer therapy for locally advanced or metastatic disease. 4. Had symptomatic brain metastasis (parenchymal or leptomeningeal). Participants with asymptomatic brain metastasis or who have stable symptoms that did not require an increased dose of corticosteroids to control symptoms in the past 7 days before the first dose of brigatinib may be enrolled. 5. Had current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Participants with leptomeningeal disease and without cord compression are allowed. 6. Had a cerebrovascular accident or transient ischemic attack within 6 months before first dose of brigatinib. 7. Had an ongoing or active infection, including, but not limited to, the requirement for intravenous antibiotics. 8. Had malabsorption syndrome or other gastrointestinal (GI) illness that could affect oral absorption of brigatinib.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Confirmed Objective Response Rate (ORR) Using RECIST v1.1 as Assessed by the Independent Review Committee (IRC) Timeframe: Up to approximately 20 months Confirmed ORR is defined as the percentage of the participants who are confirmed to have achieved complete response (CR) or partial response (PR), per RECIST version 1.1 (confirmed >=4 weeks after initial response), after the initiation of study treatment. CR: disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to <10 mm in short axis and PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions taking as reference the baseline sum diameters. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Efficacy: Confirmed ORR Using RECIST v1.1 as Assessed by the Investigator Timeframe: Until the radiological disease progression or study end (approx. 3 years) Confirmed ORR is defined as the percentage of the participants who are confirmed to have achieved CR or PR, per RECIST version 1.1 (confirmed >=4 weeks after initial response), after the initiation of study treatment. CR: disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to <10 mm in short axis and PR: at least a 30% decrease in the SLD of target lesions taking as reference the baseline sum diameters. 2.Efficacy: Duration of Response (DOR) as Assessed by the Investigator and IRC Timeframe: Until the radiological disease progression or study end (approx. 3 years) DOR is defined as the time interval from the time that the measurement criteria are first met for CR or PR until the first date that the progressive disease (PD) is objectively documented, or death. PD: SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest). SLD must also demonstrate an absolute increase of at least 5 mm. (2 lesions increasing from, for example, 2 mm to 3 mm, does not qualify). 3.Efficacy: Progression-Free Survival (PFS) as Assessed by the Investigator and IRC Timeframe Until the radiological disease progression or study end (approx. 3 years) PFS is defined as the time interval from the date of the first dose of the study treatment until the first date at which disease progression is objectively documented, or death due to any cause, whichever occurs first. PFS will be censored for participants without documented disease progression or death. 4.Efficacy: Disease Control Rate (DCR) as Assessed by the Investigator and IRC Timeframe: Until the radiological disease progression or study end (approx. 3 years) DCR is defined as the percentage of participants who have achieved CR, PR or stable disease (SD) (in the case of SD, measuremen | — |
Countries
Australia, Austria, Canada, China, France, Germany, Hong Kong, Italy, Japan, Netherlands, South Korea, Spain, Sweden, Taiwan, United States
Outcome results
None listed