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

Last updated: July 14, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

3

Condition

Non-small Cell Lung Cancer

Treatment

docetaxel

JDQ443

Clinical Study ID

NCT05132075
CJDQ443B12301
2021-002605-10
  • Ages 18-100
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant has histologically confirmed locally advanced/metastatic (stageIIIB/IIIC or IV)

  • Participant has a KRAS G12C mutation present in tumor tissue or plasma prior toenrollment, as determined by a Novartis designated central laboratory or by acceptedlocal tests.

  • Participants has received one prior platinum-based chemotherapy regimen and oneprior 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

Exclusion Criteria:

  • Participants who have previously received docetaxel (except if received inneoadjuvant or adjuvant setting with no progression within 12 months after the ofend of treatment), or any other KRAS G12C inhibitor.

  • Participant has EGFR-sensitizing mutation and/or ALK rearrangement by locallaboratory testing. Participants with other druggable alterations will be excludedif required by local guidelines.

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

  • Participant has an history of interstitial lung disease or pneumonitis grade > 1.

Other inclusion/exclusion criteria may apply

Study Design

Total Participants: 95
Treatment Group(s): 2
Primary Treatment: docetaxel
Phase: 3
Study Start date:
June 15, 2022
Estimated Completion Date:
March 30, 2026

Study Description

The study has been designed as a Phase III trial and consists of 2 parts:

  • Randomized part will evaluate the efficacy and safety of JDQ443 as monotherapy in comparison with docetaxel. Participants randomized to docetaxel arm will have the opportunity to cross-over to JDQ443 at disease progression per RECIST 1.1 confirmed by BIRC.

  • Extension part will be open after final progression-free survival (PFS) analysis (if the primary endpoint has met statistical significance) to allow participants randomized to docetaxel treatment to crossover to receive JDQ443 treatment regardless of progression on docetaxel.

The study population will include adult participants with locally advanced or metastatic (stage IIIB/IIIC or IV) KRAS G12C mutant non-small cell lung cancer (by tissue or plasma as determined by a Novartis-designated central laboratory or accepted local tests) who have received prior platinum-based chemotherapy and prior immune checkpoint inhibitor therapy administered either in sequence or as combination therapy.

Approximately 360 participants will be randomized to JDQ443 or docetaxel in a 1:1 ratio stratified by prior line of therapy and ECOG performance status.

Connect with a study center

  • Novartis Investigative Site

    Caba, Buenos Aires C1414DRK
    Argentina

    Site Not Available

  • Novartis Investigative Site

    La Plata, Buenos Aires B1900AWT
    Argentina

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  • Novartis Investigative Site

    Pilar, Buenos Aires B1629AHJ
    Argentina

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    Buenos Aires, C1431FWO
    Argentina

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    Cordoba, X5000JHQ
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    Auchenflower, Queensland 4066
    Australia

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    Hyde Park, Queensland 4812
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    South Brisbane, Queensland 4101
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    Southport, Queensland 4215
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    Rio de Janeiro, RJ 22640-000
    Brazil

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    Ijuí, RS 98700-000
    Brazil

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    Rio Grande Do Sul, 90035-001
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    Sao Paulo, 01509-010
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    Plovdiv, 4004
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    Fatih / Istanbul, 34093
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    Istanbul, 34722
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    Malatya, 44280
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    Pendik Istanbul, 34899
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    Stoke on Trent, Staffordshire ST46QG
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    Staffordshire, WS11 5XY
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  • Mid Florida Hematology And Onc Ctr

    Orange, Florida 32763
    United States

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    Orange City, Florida 32763
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    Hinsdale, Illinois 60521
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    Exeter, New Hampshire 03833
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    Lake Success, New York 11042
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    Renton, Washington 98055
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    Renton, Washington 98055
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    Hanoi, 300000
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    Ho Chi Minh, 700000
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