Not yet recruiting NCT07662473

The Efficacy and Safety of Trastuzumab Deruxtecan in Advanced or Metastatic NSCLC With HER2 Over Expression

Phase II Interventional NSCLC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Experimental Group.
Who it may be relevant to: Registry conditions: NSCLC. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) in Advanced or Metastatic NSCLC With Human Epidermal Growth Factor Receptor2(HER2) Overexpression(OE)：A Single-arm, Multicenter, Prospective Study

Overview

This is a single arm, multicenter and prospective study to evaluate the efficacy and safety of T-DXd for the treatment in locally advanced, unresectable, or metastatic participants with selected HER2 positive (IHC 3+) NSCLC which are not eligible for curative therapy

Interventions

Drug Experimental Group
All participants enrolled in the study will receive the study intervention (T-DXd) 5.4 mg/kg as an IV infusion Q3W, on Day 1 of each 3-week cycle

Primary outcome measures

To assess the efficacy of T-DXd by evaluation of Progression-free survival [Time frame: UP to approximately 3 years]

Secondary outcome measures (4)

To assess the Overall survival (OS) of T-DXd [Time frame: UP to approximately 3 years]
To assess the Objective response rate (ORR) of T-DXd [Time frame: UP to approximately 3 years]
To assess the Disease control rate (DCR) of T-DXd [Time frame: UP to approximately 3 years]
Safety and toxicity [Time frame: UP to approximately 3 years]

Eligibility criteria

Inclusion criteria

Male and female participants must be at least 18 years of age at the time of signing the ICF.
Histologically documented Stage III locally advanced and unresectable non-squamous NSCLC not amenable to curative surgery or radiation and/or Stage IV NSCLC.
Participants must have HER2 overexpression (IHC 3+).
progressed following at least one or two prior systemic treatment.
Prior anti-HER2 are eligible except for HER2 ADC.
At least 1 measurable lesion by the investigator based on RECIST 1.1.
LVEF ≥ 50% within 28 days before enrollment.
Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1.
Adequate organ and bone marrow function within 14 days before enrolment. All parameters must be the most recent results available.
Adequate treatment washout period before enrolment.
Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner.

Exclusion criteria

Has spinal cord compression or clinically active central nervous system metastases.
Corrected QT interval (QTcF) prolongation to > 470 msec (females) or >450 msec (males) based on average of the screening triplicate12-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.
Uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals
Active primary immunodeficiency, known uncontrolled active human immunodeficiency virus (HIV) infection or active hepatitis B (hepatitis B virus surface antigen or hepatitis B virus core antibody positive, at screening) or C infection.
Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of trastuzumab deruxtecan.
Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline.
Known allergy or hypersensitivity to study treatment or any of the study drug excipients
History of severe hypersensitivity reactions to other monoclonal antibodies.
Pregnant or breastfeeding female participants, or participants who are planning to become pregnant.
A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).
Any other clinically significant medical conditions, that may, in the opinion of the investigator, interfere with the participant's participation in the clinical study or evaluation of the clinical study results.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07662473 · ESR-25-22990

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗