Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT02716116 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.
NotablePrimary and study completion dates: Mar 28, 2025 to Oct 31, 2026v42
MinorRe-verified, no change to tracked fieldsv41
MinorTrial status: Recruiting to Active, Not RecruitingSite details revised at 62 of 62 sitesv40Show 1 more changeShow less
Site details revised at 62 of 62 sites
MinorStudy sites: 59 to 62v39
Show 37 earlier versionsHide 37 earlier versions
MinorStudy sites: 57 to 59v38
NotablePrimary and study completion dates: Mar 13, 2023 to Mar 28, 2025v37
NotableTrial status: Active, Not Recruiting to RecruitingEnrollment target: 324 to 334 · Site details revised at 57 of 57 sitesv36Show 2 more changesShow less
Enrollment target: 324 to 334
Site details revised at 57 of 57 sites
MinorStudy sites: 69 to 57v35
MinorRe-verified, no change to tracked fieldsv34
NotablePrimary completion date: Mar 30, 2022 to Mar 13, 2023v33
NotableLead sponsor: Millennium Pharmaceuticals, Inc. to TakedaPrimary endpoints: 8 to 5 · Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 395 to confirmed 324 · 7 morev32Show 10 more changesShow less
Primary endpoints: 8 to 5
Trial status: Recruiting to Active, Not Recruiting
Enrollment target: estimated 395 to confirmed 324
Interventions: Carboplatin (Drug), Pemetrexed (Drug), TAK-788 (Drug) to TAK-788 (Drug)
NotablePrimary completion date: May 29, 2020 to Mar 30, 2022Primary endpoints: 7 to 8 · Enrollment target: 331 to 395 · Eligibility criteria expanded, about 297 words · 4 morev30Show 7 more changesShow less
NotableTrial status: Active, Not Recruiting to RecruitingSite details revised at 69 of 69 sitesv29Show 1 more changeShow less
Site details revised at 69 of 69 sites
NotablePrimary endpoints: 5 to 7Enrollment target: 306 to 331 · Interventions: TAK-788 (Drug) to Carboplatin (Drug), Pemetrexed (Drug), TAK-788 (Drug) · Eligibility criteria expanded, about 164 words · 3 morev28Show 6 more changesShow less
Enrollment target: 306 to 331
Interventions: TAK-788 (Drug) to Carboplatin (Drug), Pemetrexed (Drug), TAK-788 (Drug)
MinorEnrollment target: estimated 97 to confirmed 306Completion date: Feb 28, 2023 to Mar 13, 2023 · Site details revised at 4 of 69 sitesv27Show 2 more changesShow less
Completion date: Feb 28, 2023 to Mar 13, 2023
Site details revised at 4 of 69 sites
MinorTrial status: Recruiting to Active, Not RecruitingSite details revised at 69 of 69 sitesv26Show 1 more changeShow less
Site details revised at 69 of 69 sites
MinorSite details revised at 43 of 69 sitesv25
NotableTrial status: Active, Not Recruiting to RecruitingSite details revised at 69 of 69 sitesv24Show 1 more changeShow less
Site details revised at 69 of 69 sites
MinorEnrollment target: estimated 341 to confirmed 97Primary completion date: Jun 1, 2020 to May 29, 2020v23Show 1 more changeShow less
Primary completion date: Jun 1, 2020 to May 29, 2020
MinorTrial status: Recruiting to Active, Not RecruitingSite details revised at 69 of 69 sitesv22Show 1 more changeShow less
Site details revised at 69 of 69 sites
MinorStudy sites: 87 to 69v21
NotableStart date: Apr 30, 2016 to Jun 16, 2016Primary completion date: Jan 28, 2020 to Jun 1, 2020 · Completion date: Jan 28, 2021 to Feb 28, 2023 · Eligibility criteria shortened, about 42 words · 1 morev20Show 4 more changesShow less
Primary completion date: Jan 28, 2020 to Jun 1, 2020
NotablePrimary endpoints: 4 to 5Study sites: 85 to 87 · Eligibility criteria expanded, about 83 words · Secondary endpoints: 24 to 25 · 1 morev19Show 4 more changesShow less
NotableEnrollment target: 105 to 250Primary endpoints: 2 to 3 · Primary completion date: May 31, 2021 to Jul 30, 2021 · Completion date: Oct 29, 2021 to Jul 30, 2021 · 5 morev13Show 8 more changesShow less
Primary endpoints: 2 to 3
Primary completion date: May 31, 2021 to Jul 30, 2021
NotablePrimary completion date: Feb 2018 to May 31, 2021Completion date: Oct 2019 to Oct 29, 2021 · Start date: Apr 2016 to Apr 30, 2016v11Show 2 more changesShow less
Completion date: Oct 2019 to Oct 29, 2021
Start date: Apr 2016 to Apr 30, 2016
MinorRe-verified, no change to tracked fieldsv10
MinorSite contacts updated at 1 of 7 sitesv9
MinorSite contacts updated at 1 of 7 sitesv8
MinorStudy sites: 6 to 7v7
MinorStudy sites: 4 to 6v6
MinorSite contacts updated at 4 of 4 sitesv5
MinorStudy sites: 1 to 4v4
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 0 to 1 · Start date: May 2016 to Apr 2016v3Show 2 more changesShow less
Study sites: 0 to 1
Start date: May 2016 to Apr 2016
MinorRe-verified, no change to tracked fieldsv2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.