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New hope for tough lung cancer: experimental drug takes on KRAS mutation

NCT ID NCT07601048

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests a new drug called HRS-7058 against other KRAS G12C inhibitors in 450 adults with advanced or metastatic non-small cell lung cancer that has a specific KRAS G12C mutation and has stopped responding to standard treatments. The study compares how well HRS-7058 works and its safety, aiming to find a better option for these patients.

What this could mean

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

Active substance
HRS-7058 (a KRAS G12C inhibitor)
What this could lead to
If successful, this could offer a new treatment option for people with a specific type of advanced lung cancer that has stopped responding to standard therapies.
What could go wrong
This is an early-stage Phase 3 trial, so results are not yet known. The new drug may not be more effective or safer than existing KRAS G12C inhibitors, and side effects are possible.

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 450 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

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. Age 18 years old to 75 years old ( including both ends ), regardless of gender ; 2. Subjects with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer ; 3. Histological specimens confirmed the presence of KRAS G12 C mutation ; 4. Participants who have failed at least one line of systemic anti-tumor treatment in the locally advanced or metastatic stage. Previous systemic anti-tumor treatment should include : platinum-containing double-agent chemotherapy and immune checkpoint inhibitor therapy ( synchronous or sequential, except that the researchers determine that it is not suitable for immune checkpoint inhibitors or chemotherapy ) ; 5. At least one measurable lesion conforming to the definition of RECIST v1.1 standard ; 6. ECOG physical score 0-1 points ; 7. Expected survival time ≥ 12 weeks ; 8. Have adequate bone marrow and organ function 9. Subjects were required to give informed consent to this study before the trial and voluntarily sign a written informed consent form. Exclusion Criteria: 1. Subjects with active central nervous system ( CNS ) metastasis ; 2. Other malignant tumors occurred within 5 years before the first administration, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, ductal carcinoma in situ after radical resection, and papillary thyroid carcinoma after radical resection. 3. Having undergone major surgery or significant trauma within 4 weeks prior to the first use of the study drug ; 4. Subjects with a history of interstitial pneumonia or suspected interstitial pneumonia by imaging examination during screening ; or other lung diseases that seriously affect lung function ; 5. Have serious cardiovascular and cerebrovascular diseases 6. Severe infection occurred within 4 weeks before the first administration. 7. The first study of arterial / venous thrombosis events within 3 months before medication was conducted. 8. Have a history of immunodeficiency, including HIV test positive ; 9. There is active hepatitis B or hepatitis C ; 10. Subjects with active central nervous system ( CNS ) metastasis ;

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Get notified about this study

Sign up to get updates when this study changes or when new studies for KRAS G12C-positive advanced or metastatic non-small cell lung cancer patients who have failed standard treatment are added.

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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 places running it

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

  2. 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 ↗

  3. 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

Locations

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China