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New hope for hard-to-treat lung cancer: targeted drug shows promise

NCT ID NCT05246514

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times

Summary

This study tests a drug called trastuzumab deruxtecan (T-DXd) in 72 people with a specific type of advanced lung cancer (HER2-mutant non-small cell lung cancer) that has worsened after at least one prior treatment. The goal is to see if the drug can shrink tumors and how safe it is. Participants receive the drug intravenously and are monitored for response and side effects.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

72 people

The number who actually took part.

Started

Jul 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HER2-mutant non-small cell lung cancer

Contacts and locations

Locations

  • Research Site

    Baoding, 071000, China

  • Research Site

    Beijing, 100142, China

  • Research Site

    Beijing, 100191, China

  • Research Site

    Changchun, 130000, China

  • Research Site

    Changsha, 410008, China

  • Research Site

    Changsha, 410013, China

  • Research Site

    Chengdu, 610041, China

  • Research Site

    Chongqing, 400030, China

  • Research Site

    Guangzhou, 510080, China

  • Research Site

    Guangzhou, 510515, China

  • Research Site

    Hangzhou, 310020, China

  • Research Site

    Hangzhou, 310022, China

  • Research Site

    Harbin, 150081, China

  • Research Site

    Hefei, 133500, China

  • Research Site

    Hefei, 230601, China

  • Research Site

    Linyi, 276000, China

  • Research Site

    Nanjing, 210029, China

  • Research Site

    Shandong, China

  • Research Site

    Shanghai, 200025, China

  • Research Site

    Shanghai, 200032, China

  • Research Site

    Shenyang, 110042, China

  • Research Site

    Shenzhen, 518020, China

  • Research Site

    Wuhan, 430022, China

  • Research Site

    Wuhan, 430060, China

  • Research Site

    Xi'an, 710061, China

  • Research Site

    Xiamen, 361003, China

  • Research Site

    Yangzhou, 225001, China

  • Research Site

    Zhengzhou, 450000, China

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