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MinorTrial status: Recruiting to Active, Not RecruitingSite details revised at 18 of 18 sitesv32Show 1 more changeShow less
Site details revised at 18 of 18 sites
NotablePrimary and study completion dates: Jan 1, 2025 to Jan 1, 2026v31
Show 29 earlier versionsHide 29 earlier versions
MinorEnrollment target: 770 to 890Eligibility criteria expanded, about 12 words · Study description expanded, about 7 wordsv30Show 2 more changesShow less
NotablePrimary endpoints: 2 to 3Interventions: Datopotamab Deruxtecan (Dato-DXd) (Drug) to Datopotamab Deruxtecan (Dato-DXd) (Drug), Non-Steroid Containing Mouthwash (Other), Steroid Containing Mouthwash (Drug) · Eligibility criteria expanded, about 148 words · Study description expanded, about 19 wordsv27Show 3 more changesShow less
NotablePrimary and study completion dates: Jan 1, 2024 to Jan 1, 2025Eligibility criteria shortened, about 207 words · Secondary endpoints: details revised at 5 of 5 entriesv26Show 2 more changesShow less
Eligibility criteria shortened, about 207 words
Secondary endpoints: details revised at 5 of 5 entries
MinorInterventions: DS-1062a (Drug) to Datopotamab Deruxtecan (Dato-DXd) (Drug)Eligibility criteria expanded, about 470 wordsv24Show 1 more changeShow less
NotableEnrollment target: 350 to 770Primary and study completion dates: Jan 1, 2022 to Jan 1, 2024 · Eligibility criteria expanded, about 653 words · Secondary endpoints revised (5) · 3 morev19Show 6 more changesShow less
Primary and study completion dates: Jan 1, 2022 to Jan 1, 2024
NotablePrimary and study completion dates: Jun 20, 2021 to Jan 1, 2022Eligibility criteria expanded, about 18 words · Study description expanded, about 6 words · Site contacts updated at 8 of 8 sitesv13Show 3 more changesShow less
NotableTrial status: Not Yet Recruiting to RecruitingEnrollment target: 132 to 160 · Study sites: 0 to 2 · Start date changed from estimate of Jan 20, 2018 to Jan 31, 2018v2Show 3 more changesShow less
Enrollment target: 132 to 160
Study sites: 0 to 2
Start date changed from estimate of Jan 20, 2018 to Jan 31, 2018
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Stopped: an ongoing trial was terminated, suspended or withdrawn.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 one single group of participants with non-small cell lung cancer (NSCLC) who have not been cured by other treatments. It is the first time the drug has been used in humans. There will be two parts and a sub-study.
The primary purpose of the parts are:
* Dose Escalation: To investigate the safety and tolerability and to determine the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of DS-1062a
* Dose Expansion: To investigate the safety and tolerability of DS-1062a in additional solid tumors
This study is expected to last approximately 6 years from the time the first participant is enrolled to the time the last subject is off the study. Study sites are located in both the United States and Japan.
The number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless:
* they withdraw
* their disease gets worse
* they experience unacceptable side effects.
The primary purpose of the sub-study is to compare the effectiveness of steroid versus non-steroid mouthwash as prophylaxis against oral mucositis/stomatitis in participants receiving DS-1062a.
The sub-study is a randomized study that will include approximately 76 participants enrolling into the Dose Expansion part.