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New drug cocktail targets Hard-to-Treat lung cancer

NCT ID NCT07377916

Disease control Sponsor: The First Affiliated Hospital of Guangzhou Medical University 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a combination of two drugs, SHR-A1811 and pertuzumab, in people with advanced non-small cell lung cancer that has HER2 mutations or overexpression and has worsened after at least one prior treatment. The goal is to see if this combo can shrink tumors or slow disease progression. About 60 participants will receive the treatment intravenously every three weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SHR-A1811 (a drug) combined with pertuzumab
What this could lead to
If successful, this combination could offer a new treatment option to control advanced HER2-altered lung cancer after initial therapy fails.
What could go wrong
This is an early exploratory study with only 60 participants and no control group. The treatment may not improve outcomes and could cause 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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

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: * Aged 18-75 years * Histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) (AJCC 9th edition) * Pathologically documented HER2 mutation, amplification, or overexpression * Received ≥1 prior line of systemic anti-cancer therapy for advanced/metastatic disease * There is at least one measurable lesion according to RECIST V1.1 criteria * ECOG score of 0 or 1. * The expected survival is ≥12 weeks Exclusion Criteria: * There are untreated or active central nervous system (CNS) tumor metastases * Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1. * Pleural, ascites, or pericardial effusion requiring intervention occurred within 14 days prior to initial administration * Systemic antitumor therapy was performed 4 weeks prior to study initiation * Subjects who have previously received HER2-targeted therapy (excluding pan-HER tyrosine kinase inhibitors) or antibody-drug conjugates with a topoisomerase I inhibitor payload. * Use of strong CYP3A4, CYP2D6, P-gp, or BCRP inhibitors or inducers within less than 5 drug half-lives prior to the first dose. * Has active infection requiring systemic treatment.

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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.

Non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. 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.

More trials for these conditions

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