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

Phase 2Active Not RecruitingNCT05246514

AstraZeneca72 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HER2-mutant Non-Small Cell Lung Cancer

Interventions

Trastuzumab deruxtecanDRUG

administered as an IV infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (28)

Research Site

Baoding, China

Research Site

Outcomes

Primary Outcomes

ICR-assessed ORR (Objective Response Rate)

Confirmed ORR, defined as the percentage of participants with confirmed complete response or partial response, as assessed by independent central review(ICR) based on RECIST 1.1.

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)

Secondary Outcomes

Investigator-assessed ORR (Objective Response Rate)

Confirmed ORR is defined as the percentage of participants who have a confirmed CR or confirmed PR, as determined by the investigator at local site per RECIST 1.1

ICR-assessed DoR (Duration of Response)

DoR is time from the initial confirmed response (CR or PR) until documented tumour progression or death from any cause.

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.

Investigator-assessed DoR (Duration of Response)

DoR is time from the initial confirmed response (CR or PR) until documented tumour progression or death from any cause.

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.

ICR-assessed and Investigator-assessed DCR (Disease Control Rate)

DCR is the percentage of participants who achieved confirmed CR, PR, or SD during study intervention.

Data from ClinicalTrials.gov

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