The Efficacy and Safety of Trastuzumab Deruxtecan in Advanced or Metastatic NSCLC With HER2 Over … (NCT07662473) | Clinical Trial Compass
Not Yet RecruitingPhase 2
The Efficacy and Safety of Trastuzumab Deruxtecan in Advanced or Metastatic NSCLC With HER2 Over Expression
30 participantsStarted 2026-07-29
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the efficacy of T-DXd by evaluation of Progression-free survival
. 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