A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC

• Status: Not yet recruiting
• Trial end date: 2024-09-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Daiichi Sankyo, Inc.
• Treatments: Trastuzumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.