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NCT05132075Active, not recruitingPhase 3

Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer

A Randomized, Controlled, Open Label, Phase III Study Evaluating the Efficacy and Safety of JDQ443 Versus Docetaxel in Previously Treated Subjects With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 25 Sept 2026

Brief summary (registry, in English)

This is a phase III randomized open label study designed to compare JDQ443 as monotherapy to docetaxel in participants with advanced non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation who have been previously treated with a platinum-based chemotherapy and immune checkpoint inhibitor therapy either in sequence or in combination.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
95 (actual)
First submitted
11 Nov 2021
Start date
15 Jun 2022
Primary completion date
3 Sept 2026
Lead sponsor
Novartis Pharmaceuticals
Diseases
Lung cancer
NCT number
NCT05132075
EU CT number
2023-510082-10-00
EudraCT number
2021-002605-10

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 95
  • From 15 Jun 2022 to the primary completion date, 3 Sept 2026
  • 47 sites in 25 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • Participant has an history of interstitial lung disease or pneumonitis grade \> 1.
    • Other inclusion/exclusion criteria may apply

Lab values

  • 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.

Other

  • Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis

Who the study is looking for

  • 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.

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (47)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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CABAArgentinaUnknown status
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PilarArgentinaUnknown status
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AuchenflowerAustraliaUnknown status
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South BrisbaneAustraliaUnknown status
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MontrealCanadaUnknown status
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SherbrookeCanadaUnknown status
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BeijingChinaUnknown status
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ChangshaChinaUnknown status
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FuzhouChinaUnknown status
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GuangzhouChinaUnknown status
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HangzhouChinaUnknown status
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HarbinChinaUnknown status
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JinanChinaUnknown status
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ShengyangChinaUnknown status
Hospital Universitario Reina Sofia
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CórdobaSpainCompleted
Hospital General Universitario Gregorio Marañón
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MadridSpainCompleted
Hospital Universitario Central De Asturias
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OviedoSpainCompleted
Hospital Universitario de Navarra
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PamplonaSpainCompleted
Turku University Hospital
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TurkuFinlandCompleted
Thoracic General Hospital of Athens "I Sotiria"
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AthensGreeceCompleted
Henry Dunant Hospital Center
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AthensGreeceCompleted
University General Hospital of Heraklion
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HeraklionGreeceCompleted
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Hong KongHong Kong SAR ChinaUnknown status
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KowloonHong Kong SAR ChinaUnknown status
Orszagos Koranyi Pulmonologiai Intezet
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Budapest XIIHungaryCompleted
Református Pulmonológiai Centrum
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TörökbálintHungaryCompleted
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DelhiIndiaUnknown status
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JaipurIndiaUnknown status
Landspitali
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ReykjavikIcelandCompleted
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
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LuccaItalyCompleted
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyCompleted
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AmmanJordanUnknown status
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Seongnam-siSouth KoreaUnknown status
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Ed DaouraLebanonUnknown status
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Mexico CityMexicoUnknown status
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Kuala LumpurMalaysiaUnknown status
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KuchingMalaysiaUnknown status
Unidade Local De Saude De Matosinhos E.P.E.
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Senhora Da HoraPortugalCompleted
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
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Cluj-NapocaRomaniaCompleted
Institute of Oncology Ljubljana
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LjubljanaSloveniaCompleted
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BangkokThailandUnknown status
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TainanTaiwanUnknown status
Valley Medical Center Research
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RentonUnited StatesUnknown status
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HanoiVietnamUnknown status
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AdanaTurkey (Türkiye)Unknown status
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AnkaraTurkey (Türkiye)Unknown status
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IstanbulTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.