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NCT05132075 · ClinicalTrials.gov registry record · Phase 3
Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer
A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 95
- Enrollment target
- 20
- Study locations
NCT05132075: Active Phase 3 study of Non-Small Cell Lung Cancer, sponsored by Novartis Pharmaceuticals.
NCT05132075 is a Phase 3 study of Non-Small Cell Lung Cancer that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 95 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05132075, a Phase 3 study of Non-Small Cell Lung Cancer, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 95 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
PFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. PFS is based on central assessment and using RECIST 1.1 criteria.
Conditions Studied
Interventions
- DRUG docetaxel
- DRUG JDQ443
Study Locations (20)
Other
- Novartis Investigative Site - Chongqing
- Novartis Investigative Site - Turku
- Novartis Investigative Site - Athens
Buenos Aires
- Novartis Investigative Site - CABA
- Novartis Investigative Site - Pilar
Queensland
- Novartis Investigative Site - Auchenflower
- Novartis Investigative Site - South Brisbane
Quebec
- Novartis Investigative Site - Montreal
- Novartis Investigative Site - Sherbrooke
Guangdong
- Novartis Investigative Site - Guangzhou
- Novartis Investigative Site - Guangzhou
Washington
- Valley Medical Center Research - Renton
Beijing Municipality
- Novartis Investigative Site - Beijing
Fujian
- Novartis Investigative Site - Fuzhou
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2022-06-15 |
| Est. Completion | 2026-03-30 |
| Phase | Phase 3 |
What the registry record for NCT05132075 still lists
NCT05132075 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which docetaxel is the first listed.
NCT05132075 names 20 study sites across 14 states, led by Other, Buenos Aires, Queensland.
Frequently Asked Questions
What is clinical trial NCT05132075 about?
NCT05132075 is a clinical study titled "Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer". 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 t...
What is the current status of trial NCT05132075?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 95 participants. The study started on 2022-06-15. Estimated completion is 2026-03-30.
What conditions does trial NCT05132075 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT05132075?
The interventions under investigation include: docetaxel (DRUG), JDQ443 (DRUG).
Who is sponsoring clinical trial NCT05132075?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05132075 being conducted?
This trial has 20 study locations across Washington, Buenos Aires, Queensland, Quebec, Beijing Municipality. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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