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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 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. The trial reports 20 study locations across 9 states.

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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).

Conditions Studied

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

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

FieldValue
Enrollment Target 95 participants
Start Date 2022-12-06
Est. Completion 2026-12-31
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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What the Registry Record Tells You About NCT05445843

The ClinicalTrials.gov registry entry for NCT05445843 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.