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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · October 28, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1/2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT02716116). This is a study registration, not published results. Lead sponsor: Takeda. Recruitment status: COMPLETED. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 324 participants (ACTUAL). Conditions: Carcinoma, Non-Small-Cell Lung. Interventions: DRUG: TAK-788. Primary outcome measures: Part 1, Dose Escalation Component: Recommended Phase 2 Dose (RP2D) of Orally Administered TAK-788 , Cycle 1 (Cycle length is equal to [=] 28 days); Part 2, Expansion Cohorts 1, 2, 4, 5 and 7: Confirmed Objective Response Rate (ORR) Assessed by the Investigator , Up to 36 months after first dose; Part 2, Expansion Cohort 3: Intracranial ORR (iORR) Assessed by Independent Review Committee (IRC) , Up to 36 months after first dose; Part 2, Expansion Cohort 6: Confirmed ORR Assessed by IRC , Up to 36 months after first dose; Part 3, Extension Cohort: Confirmed ORR Assessed by IRC , Up to 36 months after first dose. Brief summary: This study is about a medicine called TAK-788, also known as mobocertinib, given to adults with non-small cell lung cancer. The main aims of this study are to check if there are any side effects from TAK-788, to learn how TAK-788 is processed by the body, and to determine the best dose of TAK-788 to treat this condition. Participants will take TAK-788 capsules with chemotherapy. Participants will continue to take TAK-788 unless they or their doctor decide they should stop this treatment. Participants will take TAK-788 capsules with or without chemotherapy under antidiarrhea prevention to determine the safety of TAK-788 treatment. Non-Asian, non-White participants will take TAK-788 to determine the safety and tolerability of TAK-788 treatment.