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New pill takes on tough lung cancer in Late-Stage trial

NCT ID NCT05132075

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 6 times

Summary

This Phase 3 trial compares a new oral drug, JDQ443, to the standard chemotherapy docetaxel in about 95 people with advanced non-small cell lung cancer that has a specific KRAS G12C mutation. Participants have already tried platinum-based chemo and an immunotherapy drug. The study measures how long the cancer stays under control and overall survival.

What this could mean

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

Active substance
JDQ443 (a targeted drug taken by mouth)
What this could lead to
If it works, this could offer a new, more effective 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 a relatively small Phase 3 trial, and the drug may not prove better than the current standard docetaxel. Side effects from JDQ443 are still being studied.

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

95 people

The number who actually took part.

Started

Jun 2022

Expected to finish

Sep 2026

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 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.

Inclusion Criteria: * Participant has histologically confirmed locally advanced/metastatic (stage IIIB/IIIC or IV) * Participant has a KRAS G12C mutation present in tumor tissue or plasma prior to enrollment, as determined by a Novartis designated central laboratory or by accepted local tests. * Participants has received one prior platinum-based chemotherapy regimen and one prior immune checkpoint inhibitor therapy for locally advanced or metastatic disease * Participant has at least 1 evaluable (measurable or non-measurable) lesion by RECIST 1.1 at the screening visit. Exclusion Criteria: * Participants who have previously received docetaxel (except if received in neoadjuvant or adjuvant setting with no progression within 12 months after the of end of treatment), or any other KRAS G12C inhibitor. * Participant has EGFR-sensitizing mutation and/or ALK rearrangement by local laboratory testing. Participants with other druggable alterations will be excluded if required by local guidelines. * Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Participant has an history of interstitial lung disease or pneumonitis grade \> 1. Other inclusion/exclusion criteria may apply

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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.

Contacts and locations

Locations

  • Novartis Investigative Site

    CABA, Buenos Aires, C1414DRK, Argentina

  • Novartis Investigative Site

    Pilar, Buenos Aires, B1629AHJ, Argentina

  • Novartis Investigative Site

    Auchenflower, Queensland, 4066, Australia

  • Novartis Investigative Site

    South Brisbane, Queensland, 4101, Australia

  • Novartis Investigative Site

    Montreal, Quebec, H4A 3J1, Canada

  • Novartis Investigative Site

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Novartis Investigative Site

    Fuzhou, Fujian, 350014, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510080, China

  • Novartis Investigative Site

    Harbin, Heilongjiang, 150081, China

  • Novartis Investigative Site

    Changsha, Hunan, 410013, China

  • Novartis Investigative Site

    Shengyang, Liaoning, 110042, China

  • Novartis Investigative Site

    Jinan, Shandong, 250117, China

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310003, China

  • Novartis Investigative Site

    Beijing, 100730, China

  • Novartis Investigative Site

    Turku, 20521, Finland

  • Novartis Investigative Site

    Athens, GR, 115 27, Greece

  • Novartis Investigative Site

    Athens, 11526, Greece

  • Novartis Investigative Site

    Heraklion Crete., 715 00, Greece

  • Novartis Investigative Site

    Hong Kong, 999077, Hong Kong

  • Novartis Investigative Site

    Kowloon, 999077, Hong Kong

  • Novartis Investigative Site

    Budapest, 1121, Hungary

  • Novartis Investigative Site

    Reykjavik, 101, Iceland

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302019, India

  • Novartis Investigative Site

    Delhi, 110085, India

  • Novartis Investigative Site

    Lucca, LU, 55100, Italy

  • Novartis Investigative Site

    Aviano, PN, 33081, Italy

  • Novartis Investigative Site

    Roma, RM, 00128, Italy

  • Novartis Investigative Site

    Amman, 11941, Jordan

  • Novartis Investigative Site

    Ed Daoura, 90375, Lebanon

  • Novartis Investigative Site

    Kuching, Sarawak, 93586, Malaysia

  • Novartis Investigative Site

    Kuala Lumpur, 59100, Malaysia

  • Novartis Investigative Site

    Mexico City, 06760, Mexico

  • Novartis Investigative Site

    Matosinhos Municipality, 4454-513, Portugal

  • Novartis Investigative Site

    Porto, 4100-180, Portugal

  • Novartis Investigative Site

    Cluj-Napoca, Cluj, 400015, Romania

  • Novartis Investigative Site

    Ljubljana, 1000, Slovenia

  • Novartis Investigative Site

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Novartis Investigative Site

    Pamplona, Navarre, 31008, Spain

  • Novartis Investigative Site

    Oviedo, Principality of Asturias, 33011, Spain

  • Novartis Investigative Site

    Córdoba, 14004, Spain

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Tainan, 704302, Taiwan

  • Novartis Investigative Site

    Bangkok, 10330, Thailand

  • Novartis Investigative Site

    Adana, Adana, 01140, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, Bilkent-Cankaya, 06800, Turkey (Türkiye)

  • Novartis Investigative Site

    Istanbul, Fatih, 34093, Turkey (Türkiye)

  • Novartis Investigative Site

    Istanbul, Pendik, 34899, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, Yenimahalle, 06500, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, 06680, Turkey (Türkiye)

  • Novartis Investigative Site

    Hanoi, 300000, Vietnam

  • Valley Medical Center Research

    Renton, Washington, 98055, United States

More trials for these conditions

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