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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-13

Study Completion Date

2026-03-16

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of T-DXd in participants with HER2 mutant metastatic non-squamous NSCLC.

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Detailed Description

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Conditions

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HER2-mutant Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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T-DXd arm

Participants will receive T-DXd as an IV infusion Q3W, on Day 1 of each 3-week cycle.

Group Type EXPERIMENTAL

Trastuzumab deruxtecan

Intervention Type DRUG

administered as an IV infusion

Interventions

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Trastuzumab deruxtecan

administered as an IV infusion

Intervention Type DRUG

Other Intervention Names

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T-DXd, DS-8201a

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No