New pill takes on tough lung cancer in Late-Stage trial
NCT ID NCT05132075
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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95 people
The number who actually took part.
- Started
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Jun 2022
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Novartis Investigative Site
CABA, Buenos Aires, C1414DRK, Argentina
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Novartis Investigative Site
Pilar, Buenos Aires, B1629AHJ, Argentina
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Novartis Investigative Site
Auchenflower, Queensland, 4066, Australia
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Novartis Investigative Site
South Brisbane, Queensland, 4101, Australia
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Novartis Investigative Site
Montreal, Quebec, H4A 3J1, Canada
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Novartis Investigative Site
Sherbrooke, Quebec, J1H 5N4, Canada
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Novartis Investigative Site
Fuzhou, Fujian, 350014, China
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Novartis Investigative Site
Guangzhou, Guangdong, 510080, China
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Novartis Investigative Site
Harbin, Heilongjiang, 150081, China
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Novartis Investigative Site
Changsha, Hunan, 410013, China
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Novartis Investigative Site
Shengyang, Liaoning, 110042, China
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Novartis Investigative Site
Jinan, Shandong, 250117, China
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Novartis Investigative Site
Hangzhou, Zhejiang, 310003, China
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Novartis Investigative Site
Beijing, 100730, China
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Novartis Investigative Site
Turku, 20521, Finland
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Novartis Investigative Site
Athens, GR, 115 27, Greece
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Novartis Investigative Site
Athens, 11526, Greece
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Novartis Investigative Site
Heraklion Crete., 715 00, Greece
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Novartis Investigative Site
Hong Kong, 999077, Hong Kong
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Novartis Investigative Site
Kowloon, 999077, Hong Kong
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Novartis Investigative Site
Budapest, 1121, Hungary
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Novartis Investigative Site
Reykjavik, 101, Iceland
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Novartis Investigative Site
Jaipur, Rajasthan, 302019, India
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Novartis Investigative Site
Delhi, 110085, India
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Novartis Investigative Site
Lucca, LU, 55100, Italy
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Novartis Investigative Site
Aviano, PN, 33081, Italy
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Novartis Investigative Site
Roma, RM, 00128, Italy
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Novartis Investigative Site
Amman, 11941, Jordan
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Novartis Investigative Site
Ed Daoura, 90375, Lebanon
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Novartis Investigative Site
Kuching, Sarawak, 93586, Malaysia
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Novartis Investigative Site
Kuala Lumpur, 59100, Malaysia
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Novartis Investigative Site
Mexico City, 06760, Mexico
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Novartis Investigative Site
Matosinhos Municipality, 4454-513, Portugal
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Novartis Investigative Site
Porto, 4100-180, Portugal
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Novartis Investigative Site
Cluj-Napoca, Cluj, 400015, Romania
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Novartis Investigative Site
Ljubljana, 1000, Slovenia
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Novartis Investigative Site
Seongnam-si, Gyeonggi-do, 13620, South Korea
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Novartis Investigative Site
Pamplona, Navarre, 31008, Spain
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Novartis Investigative Site
Oviedo, Principality of Asturias, 33011, Spain
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Novartis Investigative Site
Córdoba, 14004, Spain
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Novartis Investigative Site
Madrid, 28009, Spain
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Novartis Investigative Site
Tainan, 704302, Taiwan
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Novartis Investigative Site
Bangkok, 10330, Thailand
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Novartis Investigative Site
Adana, Adana, 01140, Turkey (Türkiye)
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Novartis Investigative Site
Ankara, Bilkent-Cankaya, 06800, Turkey (Türkiye)
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Novartis Investigative Site
Istanbul, Fatih, 34093, Turkey (Türkiye)
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Novartis Investigative Site
Istanbul, Pendik, 34899, Turkey (Türkiye)
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Novartis Investigative Site
Ankara, Yenimahalle, 06500, Turkey (Türkiye)
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Novartis Investigative Site
Ankara, 06680, Turkey (Türkiye)
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Novartis Investigative Site
Hanoi, 300000, Vietnam
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Valley Medical Center Research
Renton, Washington, 98055, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Surgeons could freeze lung tumors from miles away using 5G robots
- Two-Drug combo targets stubborn KRAS lung cancer
- Smaller chest drain may speed recovery after lung cancer surgery
- Gut bacteria may hold clues to why some cancer treatments work better
- Breath-Tracking sensor aims to sharpen lung cancer scans
- Can PET scan signals predict who beats lung cancer with immunotherapy?