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New drug combo takes aim at a Hard-to-Treat lung cancer mutation

NCT ID NCT07822542

Disease control Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are testing whether adding the experimental oral drug HS-10370 to platinum-based chemotherapy, with or without the immunotherapy adebrelimab, works better than tislelizumab plus chemotherapy. The trial enrolls about 448 adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer that carries a KRAS G12C mutation. The main goal is to see how long participants live without their 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-10370, an experimental oral drug, given with platinum-based chemotherapy, with or without the immunotherapy adebrelimab
What this could lead to
If it works, this could offer a new first-line option for people with KRAS G12C non-squamous lung cancer, a group with limited targeted treatment choices.
What could go wrong
The trial is still testing whether adding HS-10370 improves outcomes over standard immunotherapy plus chemotherapy. Combinations can add side effects, and a phase 3 result may show no advantage or unexpected toxicity.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 448 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

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: * Participants are able to comply with the process of the protocol. * Men or women greater than or equal to 18 years * At least one measurable lesion in accordance with RECIST 1.1 * Must have an ECOG performance status of 0 or 1. * Must have adequate laboratory parameters. * Patients with advanced solid tumors who have failed after adequate standard treatment, are intolerant to standard treatment, or have no standard treatment available. * Documentation of the presence of a KRAS G12C mutation * Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose.Men also consent to use adequate contraceptive method within the same time limit. Exclusion Criteria: * Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved, except for KRAS G12C. * Treatment with any of the following: Previous or current treatment with other KRAS G12C inhibitors. * Active brain metastases. * Participants with uncontrolled pleural, ascites or pericardial effusion * History of other primary malignancies. * Abnormal cardiac examination results. * Severe, uncontrolled or active cardiovascular disorders. * Uncontrolled hypertension. * Severe bleeding symptoms or bleeding tendencies. * Severe arteriovenous thrombosis occurred * Serious infection. * Continuous use of glucocorticoids * Active infectious diseases. * Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications * Interstitial lung disease (ILD). * Serious neurological or mental disorders. * Active autoimmune diseases.

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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.

Carcinoma, non-small-cell lung

How to take part

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  1. The official record

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