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

Running, not enrolling · Phase 3

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT05132075

Run by

Novartis Pharmaceuticals

People needed

95

Starts

2022-06-15

Expected to finish

2026-09-23

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — Pilar, Buenos Aires, Argentina
• Novartis Investigative Site — Auchenflower, Queensland, Australia
• Novartis Investigative Site — South Brisbane, Queensland, Australia
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Sherbrooke, Quebec, Canada
• Novartis Investigative Site — Fuzhou, Fujian, China
• Novartis Investigative Site — Guangzhou, Guangdong, China
• Novartis Investigative Site — Harbin, Heilongjiang, China
• Novartis Investigative Site — Changsha, Hunan, China
• Novartis Investigative Site — Shengyang, Liaoning, China
• Novartis Investigative Site — Jinan, Shandong, China
• Novartis Investigative Site — Hangzhou, Zhejiang, China
• Novartis Investigative Site — Beijing, China
• Novartis Investigative Site — Turku, Finland
• Novartis Investigative Site — Athens, GR, Greece
• Novartis Investigative Site — Athens, Greece
• Novartis Investigative Site — Heraklion Crete., Greece
• Novartis Investigative Site — Hong Kong, Hong Kong
• Novartis Investigative Site — Kowloon, Hong Kong
• Novartis Investigative Site — Budapest, Hungary
• Novartis Investigative Site — Reykjavik, Iceland
• Novartis Investigative Site — Jaipur, Rajasthan, India
• Novartis Investigative Site — Delhi, India
• Valley Medical Center Research — Renton, Washington, United States

Full record on ClinicalTrials.gov

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