A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC
- Sponsor
- AstraZeneca
- Study ID
- NCT05246514
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- HER2-mutant Non-Small Cell Lung Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Trastuzumab deruxtecan — DRUGadministered as an IV infusion
Study Details
The purpose of this study is to evaluate the efficacy and safety of T-DXd in participants with HER2 mutant metastatic non-squamous NSCLC.
Key Dates
- Start date
- Jul 13, 2022
- Status verified
- Apr 2026
- Primary completion
- Nov 4, 2024
- Completion
- Jun 30, 2026
Study Design
- Enrollment
- 72 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: T-DXd armParticipants will receive T-DXd as an IV infusion Q3W, on Day 1 of each 3-week cycle.
Primary Outcome Measure
ICR-assessed ORR (Objective Response Rate) [ Time Frame: Tumour assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of enrolment and then every 9 weeks thereafter. Assessed up to 28 months. (from date of enrolment to final analysis data cut-off) ]