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New pill combo takes on hard-to-treat lung cancer in major trial

NCT ID NCT07174908

Disease control Sponsor: InxMed (Shanghai) Co., Ltd. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This phase 3 trial tests two oral drugs (IN10018 and D-1553) against standard chemotherapy plus immunotherapy for people with advanced non-small cell lung cancer that has a specific KRAS G12C mutation. About 400 participants who have not had prior treatment will be randomly assigned to one of the two options. The main goal is to see if the new drug combination delays cancer progression better than current therapy.

What this could mean

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

Active substance
IN10018 and D-1553 (oral drugs)
What this could lead to
If successful, this combination could offer a new targeted treatment option for people with a specific type of lung cancer (KRAS G12C mutation), potentially improving how long they live without their cancer growing.
What could go wrong
This is a phase 3 trial, but it's still experimental. The new combination may not work better than current standard therapy, and side effects are unknown. Results may not apply to all lung cancer patients.

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 400 people

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

Started

Sep 2025

Expected to finish

Sep 2030

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 80 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: * Able and willing to provide informed consent and comply with study requirements * Has histologically confirmed locally advanced (Stage IIIB/C) or metastatic (Stage IV) non-squamous NSCLC * Aged 18-80 years at the time of consent * Has KRAS G12C mutation confirmed by central laboratory * Has not received prior systemic therapy for advanced or metastatic NSCLC * Has at least one measurable lesion per RECIST v1.1 * ECOG performance status of 0-1 * Has adequate organ function * Life expectancy ≥3 months in the opinion of the Investigator * Male and female subjects of reproductive potential must agree to use effective contraception during and for 6 months after treatment Exclusion Criteria: * Has other histological subtypes of NSCLC (e.g., small cell or neuroendocrine) * Has active or untreated CNS metastases or carcinomatous meningitis * Prior treatment with KRAS G12C inhibitors, FAK inhibitors, or immune checkpoint inhibitors * Has another known driver mutation with approved targeted therapy (e.g., EGFR, ALK, ROS1) * Has uncontrolled cardiovascular disease, active severe infection, interstitial lung disease, or autoimmune disease requiring systemic therapy * Has history of another malignancy within 5 years, except those curatively treated and considered low risk (e.g., basal cell carcinoma, cervical carcinoma in situ) * Has gastrointestinal conditions that may interfere with absorption of oral drugs (if applicable) * Has known active hepatitis B, hepatitis C, or HIV infection * Has received a live vaccine within 30 days before first dose of study drug * Pregnant or breastfeeding women * Has psychiatric or substance abuse disorders that would interfere with study compliance * Is participating in another interventional clinical study * Any condition that, in the opinion of the Investigator, would interfere with participation or study results

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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 places running it

    11 sites. 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

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • First Affiliated Hospital of Gannan Medical University

    NOT_YET_RECRUITING

    Gannan, Jiangxi, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, China

  • Hunan Cancer Hospital

    NOT_YET_RECRUITING

    Changsha, Hunan, China

  • Jiangsu Cancer Hospital

    RECRUITING

    Nanjing, Jiangsu, China

  • Shanghai Chest Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • The First Affiliated Hospital of Nanchang University

    NOT_YET_RECRUITING

    Nanchang, Jiangxi, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, China

  • The First Affiliated Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, China

  • Union Hospital Tongji Medidcal College Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310005, China

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Other studies related to the condition(s) this trial covers.