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NCT05445843 · ClinicalTrials.gov registry record · Phase 2
Study of Efficacy and Safety of JDQ443 Single-agent as First-line Treatment for Patients With Locally Advanced or Metastatic KRAS G12C- Mutated Non-small Cell Lung Cancer With a PD-L1 Expression < 1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation.
A Phase 2 study of Locally Advanced or Metastatic KRAS G12C-mutated NSCLC With a PD-L1 Expression <1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 95
- Enrollment target
- 20
- Study locations
NCT05445843: Active Phase 2 study of Locally Advanced or Metastatic KRAS G12C-mutated NSCLC With a PD-L1 Expression <1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation, sponsored by Novartis Pharmaceuticals.
NCT05445843 is a Phase 2 study of Locally Advanced or Metastatic KRAS G12C-mutated NSCLC With a PD-L1 Expression <1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 95 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05445843, a Phase 2 study of Locally Advanced or Metastatic KRAS G12C-mutated NSCLC With a PD-L1 Expression <1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 95 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study aims to evaluate the antitumor activity and safety of JDQ443 single-agent as first-line treatment for participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor a KRAS G12C mutation and have a PD-L1 expression \< 1% (cohort A) or a PD-L1 expression ≥ 1% and an STK11 co-mutation (cohort B).
Primary Outcome
Overall Response Rate (ORR) was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) as best overall response (BOR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by the Investigator in Cohort A.
Conditions Studied
Interventions
- DRUG JDQ443
Study Locations (20)
Other
- Novartis Investigative Site - Buenos Aires
- Novartis Investigative Site - Córdoba
- Novartis Investigative Site - Córdoba
- Novartis Investigative Site - Feldkirch
- Novartis Investigative Site - Wels
- Novartis Investigative Site - Belo Horizonte
- Novartis Investigative Site - Rio de Janeiro
- Novartis Investigative Site - Beijing
- Novartis Investigative Site - Bron
- Novartis Investigative Site - Montpellier
- Novartis Investigative Site - Saint-Herblain
- Novartis Investigative Site - Strasbourg
Rhode Island
- The Brown University Oncology Group - Providence
Buenos Aires
- Novartis Investigative Site - Pilar
Oost Vlaanderen
- Novartis Investigative Site - Sint-Niklaas
West-Vlaanderen
- Novartis Investigative Site - Roeselare
Estado de Bahia
- Novartis Investigative Site - Salvador
Hubei
- Novartis Investigative Site - Wuhan
Hunan
- Novartis Investigative Site - Changsha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2022-12-06 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What the registry record for NCT05445843 still lists
NCT05445843 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower).
The record links to 1 condition, with Locally Advanced or Metastatic KRAS G12C-mutated NSCLC With a PD-L1 Expression <1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation appearing as the primary indexed condition, and to 1 intervention - of which JDQ443 is the first listed.
NCT05445843 names 20 study sites across 9 states, led by Other, Rhode Island, Buenos Aires.
Frequently Asked Questions
What is clinical trial NCT05445843 about?
NCT05445843 is a clinical study titled "Study of Efficacy and Safety of JDQ443 Single-agent as First-line Treatment for Patients With Locally Advanced or Metastatic KRAS G12C- Mutated Non-small Cell Lung Cancer With a PD-L1 Expression < 1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation.". This study aims to evaluate the antitumor activity and safety of JDQ443 single-agent as first-line treatment for participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor a KRAS G12C mutation and have a PD-L1 expression \< 1% (cohort A) or a PD-L1 expres...
What is the current status of trial NCT05445843?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2022-12-06. Estimated completion is 2026-12-31.
What conditions does trial NCT05445843 study?
This clinical trial studies the following conditions: Locally Advanced or Metastatic KRAS G12C-mutated NSCLC With a PD-L1 Expression <1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation.
What interventions are being tested in trial NCT05445843?
The interventions under investigation include: JDQ443 (DRUG).
Who is sponsoring clinical trial NCT05445843?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05445843 being conducted?
This trial has 20 study locations across Rhode Island, Buenos Aires, Oost Vlaanderen, West-Vlaanderen, Estado de Bahia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05445843's enrollment target sits among peer trials
95 759th of 2000 higher than 1,237 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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