Targeted Antibody-Drug combo shows promise for Hard-to-Treat lung cancer
NCT ID NCT07662473
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests the drug trastuzumab deruxtecan (T-DXd) in people with advanced or metastatic non-small cell lung cancer (NSCLC) that has high levels of the HER2 protein. Participants receive T-DXd by IV every three weeks. The study measures how long the cancer stays under control and overall survival. It enrolls about 30 adults whose cancer has worsened after at least one prior treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- trastuzumab deruxtecan (T-DXd)
- What this could lead to
- If successful, this could offer a new treatment option for people with advanced lung cancer that overproduces HER2 protein.
- What could go wrong
- This is a small, early-phase study with only 30 participants, so results may not apply broadly. The drug can cause serious side effects like lung inflammation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male and female participants must be at least 18 years of age at the time of signing the ICF. 2. Histologically documented Stage III locally advanced and unresectable non-squamous NSCLC not amenable to curative surgery or radiation and/or Stage IV NSCLC. 3. Participants must have HER2 overexpression (IHC 3+). 4. progressed following at least one or two prior systemic treatment. 5. Prior anti-HER2 are eligible except for HER2 ADC. 6. At least 1 measurable lesion by the investigator based on RECIST 1.1. 7. LVEF ≥ 50% within 28 days before enrollment. 8. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1. 9. Adequate organ and bone marrow function within 14 days before enrolment. All parameters must be the most recent results available. 10. Adequate treatment washout period before enrolment. 11. 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: 1. Has spinal cord compression or clinically active central nervous system metastases. 2. Corrected QT interval (QTcF) prolongation to \> 470 msec (females) or \>450 msec (males) based on average of the screening triplicate12-lead ECG. 3. 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. 4. Uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals 5. 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. 6. 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. 7. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline. 8. Known allergy or hypersensitivity to study treatment or any of the study drug excipients 9. History of severe hypersensitivity reactions to other monoclonal antibodies. 10. Pregnant or breastfeeding female participants, or participants who are planning to become pregnant. 11. A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART). 12. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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- Can a targeted drug tame HER2-Mutant lung cancer?