NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs041210103

Registered date:22/11/2021

WJOG 14720L

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedUntreated ALK-rearranged non-squamous non-small cell lung cancer
Date of first enrollment20/01/2022
Target sample size110
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)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 period at 90mg) combined with carboplatin area under the curve 5 and pemetrexed 500 mg/m2 in a 3-week cycle for up to four cycles, followed by concurrent brigatinib and pemetrexed maintenance

Outcome(s)

Primary OutcomeProgression free survival
Secondary OutcomeObjective response rate, Overall survival, proportion of adverse events, evaluation of tumor-derived DNA with gene alteration from plasma specimens

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1.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
Exclude criteria1.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.

Related Information

Contact

Public contact
Name Wakuda Kazushige
Address 1007 Shimonagakubo, Nagaizumi-cho, Suntou-gun, Shizuoka 411-8777, Japan Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail k.wakuda@scchr.jp
Affiliation Shizuoka Cancer Center
Scientific contact
Name Kenmotsu Hirotsugu
Address 1007 Shimonagakubo, Nagaizumi-cho, Suntou-gun, Shizuoka 411-8777, Japan Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail h.kenmotsu@scchr.jp
Affiliation Shizuoka Cancer Center