Two-Drug combo takes aim at Hard-to-Treat lung cancer

NCT ID NCT07824882

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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.
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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers are testing whether adding the immunotherapy adebrelimab to HS-20093 (risvutatug rezetecan) works better than HS-20093 alone in adults with advanced or metastatic non-squamous non-small cell lung cancer that has already been treated and has no actionable gene changes. About 76 participants will be randomly assigned to receive either the combination or HS-20093 by itself. The trial measures how many people see their tumors shrink and how long they live without the cancer getting worse.

What this could mean

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

Active substance
HS-20093 (risvutatug rezetecan) combined with adebrelimab
What this could lead to
If the combination works, it could offer a stronger treatment option for advanced non-squamous non-small cell lung cancer that has already been treated and lacks targetable gene changes.
What could go wrong
This is a phase 2 trial with 76 participants, so any benefit seen may not hold in larger studies. Combining two drugs can also add side effects, and the cancer may not respond.

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 76 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 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 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: 1. Age ≥18 years at the time of informed consent form (ICF) signature, either sex. 2. Be willing to participate in this clinical trial with understanding of study procedures, ability to provide written informed consent, and commitment to comply with all requirements specified in this clinical trial protocol. 3. Previously treated patients with histologically or cytologically confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC). 4. Presence of at least one measurable target lesion. 5. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1. 6. Minimum life expectancy \>12 weeks. 7. Adequate organ function. 8. Absence of the following active infectious diseases: hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, tuberculosis, or syphilis. 9. Female participants with negative serum pregnancy test result within 7 days prior to first dose administration, or documentation of no pregnancy risk. Exclusion Criteria: 1. Prior pathological diagnosis of mixed non-small cell lung cancer or any transformed non-small cell lung cancer. 2. Prior or ongoing treatment with any of the following: 1. Prior or current treatment targeting B7-H3; 2. Prior or current treatment with topoisomerase I inhibitor agents, including antibody-drug conjugates with topoisomerase I inhibitor payloads, etc.; 3. Prior treatment with docetaxel monotherapy or in combination with other agents. 3. Persistent adverse reactions caused by prior treatment. 4. Untreated brain metastases; uncontrolled brain metastases; presence of leptomeningeal or brainstem metastases; presence of spinal cord compression (identified by radiographic imaging, regardless of symptoms). 5. History of other primary malignancies. 6. Presence of any of the following abnormal cardiac findings: 1. Evidence of currently clinically significant important arrhythmia or ECG abnormality; 2. Presence of risk factors causing QT interval prolongation or arrhythmic events. 7. Severe, uncontrolled, or active cardiovascular or cerebrovascular disease. 8. Severe or poorly controlled hypertension. 9. Severe or poorly controlled diabetes mellitus. 10. Clinically significant bleeding symptoms or significant bleeding tendency. 11. Severe infection. 12. History of severe arterial or venous thromboembolic events. 13. Known or suspected interstitial pneumonitis, immune-mediated pneumonitis, or radiation pneumonitis. 14. Participants with active or history of autoimmune disease with potential for recurrence. 15. Prior occurrence of severe or life-threatening immune-mediated adverse events.

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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.

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  1. The official record

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