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Targeted pill shows promise for rare lung cancer mutation in chinese patients

NCT ID NCT04677595

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an oral targeted drug called capmatinib in 36 Chinese adults with advanced non-small cell lung cancer that has a specific MET gene mutation (exon 14 skipping). The drug aims to block faulty signals that help cancer grow. Researchers measured how many patients' tumors shrank or disappeared.

What this could mean

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

Active substance
capmatinib (oral targeted therapy)
What this could lead to
If successful, this could provide a new targeted treatment option for Chinese patients with this specific type of lung cancer.
What could go wrong
This is a small Phase 2 study with only 36 participants, so results may not apply to all patients. The drug may not work as well in a broader population or may have side effects.

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

36 people

The number who actually took part.

Started

May 2021

Finished

May 2025

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 100 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.

Key Inclusion Criteria: * Chinese adult ≥ 18 years old at the time of informed consent * Histologically confirmed stage IIIB, IIIC or IV NSCLC at the time of study entry, not amenable to curative surgery or radiation or multi-modality therapy (according to staging definition in CSCO guidelines for primary lung cancer, 2019). * Histologically or cytologically confirmed diagnosis of NSCLC that is: 1. EGFR wt: The EGFR wt status assessed as part of standard of care (EGFR mutations that predict sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 L858R substitution mutations) 2. AND ALK rearrangement negative: assessed as part of standard of care by validated test 3. AND either: Cohort 1: Treatment naive participants with MET mutations, or Cohort 2: Pre-treated participants with MET mutations * Cohort 1: participants must not have received any systemic therapy for advanced/metastatic disease (stage IIIB, IIIC or IV NSCLC). Neo-adjuvant and adjuvant systemic therapies will not count as one prior line of treatment if relapse occurred \> 12 months from the end of the neo-adjuvant or adjuvant systemic therapy. * Cohort 2: participants must have failed one or two prior lines of systemic therapy for advanced/metastatic disease (stage IIIB, IIIC or IV NSCLC). * At least one measurable lesion according to RECIST v1.1. * Adequate organ function * ECOG performance status (PS) ≤1 Key Exclusion Criteria: * Prior treatment with any MET inhibitor or HGF-targeting therapy. * Known druggable molecular alterations (such as ROS1 translocation or BRAF mutation, etc.) which might be a candidate for alternative targeted therapies as applicable per local regulations and treatment guidelines. * Participants with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms. * Presence or history of interstitial lung disease or interstitial pneumonitis, including, clinically significant radiation pneumonitis affecting activities of daily living or requiring therapeutic intervention. * Substance abuse, active infection (including active hepatitis B and C, participants whose disease is controlled under antiviral therapy are eligible, and human immunodeficiency virus (HIV) history positive) or other severe, acute, or chronic medical or psychotic conditions or laboratory abnormalities that in the opinion of the investigator may increase the risk associated with study participation, or that may interfere with the interpretation of 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 (NSCLC)

Contacts and locations

Locations

  • Novartis Investigative Site

    Xiamen, Fujian, 361001, China

  • Novartis Investigative Site

    Foshan, Guangdong, 528000, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510080, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510515, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 524000, China

  • Novartis Investigative Site

    Harbin, Heilongjiang, 150000, China

  • Novartis Investigative Site

    Zhengzhou, Henan, 450003, China

  • Novartis Investigative Site

    Wuhan, Hubei, 430024, China

  • Novartis Investigative Site

    Shenyang, Liaoning, 110001, China

  • Novartis Investigative Site

    Jinan, Shandong, 250117, China

  • Novartis Investigative Site

    Shanghai, Shanghai Municipality, 200030, China

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041, China

  • Novartis Investigative Site

    Kunming, Yunnan, 650106, China

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310022, China

  • Novartis Investigative Site

    Beijing, 100142, China

  • Novartis Investigative Site

    Shanghai, 200030, China

  • Novartis Investigative Site

    Tianjin, 300052, China

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