Status:
ACTIVE_NOT_RECRUITING
A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Daiichi Sankyo
Conditions:
HER2-mutant Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of T-DXd in participants with HER2 mutant metastatic non-squamous NSCLC.
Eligibility Criteria
Inclusion
- Pathologically documented metastatic non-squamous NSCLC.
- Has relapsed from or is refractory to at least one-line of anticancer treatment.
- Documented HER2 exon 19 or 20 mutation from central FFPE tumour tissue testing.
- WHO or ECOG performance status of 0 or 1.
- Presence of at least one measurable lesion assessed by the investigator based on RECIST 1.1.
- LVEF ≥ 50% within 28 days before enrolment.
Exclusion
- Mixed small cell lung cancer, squamous histology NSCLC, and sarcomatoid histology variant NSCLC.
- Corrected QT interval (QTcF) prolongation to \> 470 ms (females) or \> 450 ms (males), based on average of the screening triplicate 12-lead ECG.
- History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- Has unresolved toxicities from previous anticancer therapy, defined as toxicities (excluding alopecia) not yet resolved to Grade ≤1 or baseline. Participants with clinically stable chronic Grade 2 toxicity not reasonably expected to be exacerbated by study intervention may be included only after consultation with the AstraZeneca study physician or designee.
- Has been previously treated with HER2-targeted therapies, except for pan-HER class TKIs or has received prior treatment with an ADC which consists of an exatecan derivative that is a topoisomerase I inhibitor.
Key Trial Info
Start Date :
July 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05246514
Start Date
July 13 2022
End Date
March 16 2026
Last Update
August 28 2025
Active Locations (28)
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1
Research Site
Baoding, China, 071000
2
Research Site
Beijing, China, 100142
3
Research Site
Beijing, China, 100191
4
Research Site
Changchun, China, 130000