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New drug cocktail targets tough lung cancer

NCT ID NCT07669779

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 15, 2026 · Updated 2 times

Summary

This phase 2 trial tests a new drug called AK146D1, given together with other cancer drugs, in 348 people with advanced non-small cell lung cancer that cannot be surgically removed. The study aims to see if the combination is safe and can shrink tumors. Participants will receive the drugs by injection or infusion, and researchers will monitor side effects and how long the cancer stays under control.

What this could mean

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

Active substance
AK146D1 (a bispecific antibody-drug conjugate targeting Trop2 and Nectin4) combined with AK112 (a bispecific antibody targeting PD-1 and VEGF) or other anticancer drugs
What this could lead to
If successful, this could provide a new treatment option for advanced non-small cell lung cancer that has not responded to other therapies.
What could go wrong
This is an early phase 2 trial, so the combination may not prove effective or safe enough for wider use. Side effects from the drug combination are possible and being studied.

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

About 348 people

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

Started

Jul 2026

Expected to finish

May 2029

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 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: 1. Be able to understand and voluntarily sign the written informed consent form. 2. Aged of ≥ 18 years and ≤75 years. 3. ECOG PS 0 or 1. 4. The expected lifespan is ≥3 months. 5. Patients with histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) who are not eligible for curative surgical resection and cannot receive definitive concurrent or sequential chemoradiotherapy. 6. At least one measurable non-brain lesion according to RECIST v1.1. 7. Have sufficient organ function. 8. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception. Exclusion Criteria: 1. NSCLC mixed with a component of small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma. 2. Having other active malignancies within 3 years. 3. Currently participating in another interventional clinical study. 4. Presence of active metastases to the central nervous system. For patients with asymptomatic brain metastasis or stable symptoms after treatment can be included. 5. Having received any treatment targeting Trop2 or Nectin4. 6. Prior chemotherapy or antibody-drug conjugate (ADC) therapy targeting topoisomerase I inhibitors. 7. Receipt of systemic anti-tumor therapy (including chemotherapy, immunotherapy, biological agents, etc.) within 4 weeks (or 5 half-lives of the drug, whichever is longer) prior to the first dose. 8. Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 6.0 grade 1 or lower. 9. Subjects with clinically significant cardiovascular or cerebrovascular diseases or risks. 10. Subjects with active autoimmune diseases requiring systemic treatment within 2 years. 11. Receipt of systemic anti-infective therapy within 2 weeks prior to the first dose. 12. Known to be positive for HIV and other infections. 13. Previous history of severe hypersensitivity reactions. 14. Live attenuated vaccines were received within 4 weeks. 15. Subjects with a history of mental illness and incapacitated or limited capacity. 16. Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.

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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. 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 ↗

  4. 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.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • SunYat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, China

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