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Clinical Trials in India / NCT05132075
Active, not recruiting Phase 3

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

NCT05132075 · tracked via the Priya Life Science India tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Started
2022-06-15
Last updated
2026-08-27

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

JDQ443docetaxel

JDQ443: JDQ443 tablets, orally administered

docetaxel: docetaxel concentrated solution for infusion, intravenously administered

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

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (51)

FacilityCityRegionStatus
Valley Medical Center Research Renton Washington
Novartis Investigative Site CABA Buenos Aires
Novartis Investigative Site Pilar Buenos Aires
Novartis Investigative Site Auchenflower Queensland
Novartis Investigative Site South Brisbane Queensland
Novartis Investigative Site Montreal Quebec
Novartis Investigative Site Sherbrooke Quebec
Novartis Investigative Site Fuzhou Fujian
Novartis Investigative Site Guangzhou Guangdong
Novartis Investigative Site Harbin Heilongjiang
Novartis Investigative Site Changsha Hunan
Novartis Investigative Site Shengyang Liaoning
Novartis Investigative Site Jinan Shandong
Novartis Investigative Site Hangzhou Zhejiang
Novartis Investigative Site Beijing China
Novartis Investigative Site Turku Finland
Novartis Investigative Site Athens GR
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
Novartis Investigative Site Delhi India
Novartis Investigative Site Lucca LU
Novartis Investigative Site Aviano PN
Novartis Investigative Site Roma RM
Novartis Investigative Site Amman Jordan
Novartis Investigative Site Ed Daoura Lebanon
Novartis Investigative Site Kuching Sarawak
Novartis Investigative Site Kuala Lumpur Malaysia
Novartis Investigative Site Mexico City Mexico
Novartis Investigative Site Matosinhos Municipality Portugal
Novartis Investigative Site Porto Portugal
Novartis Investigative Site Cluj-Napoca Cluj
Novartis Investigative Site Ljubljana Slovenia
Novartis Investigative Site Seongnam-si Gyeonggi-do
Novartis Investigative Site Pamplona Navarre
Novartis Investigative Site Oviedo Principality of Asturias

+ 11 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05132075 on ClinicalTrials.gov ↗ ← All trials in India