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Clinical Trials in the UK / NCT05445843
Active, not recruiting 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.

NCT05445843 · tracked via the Priya Life Science UK tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 2
Started
2022-12-06
Last updated
2026-09-10

Condition(s) 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

Investigational drug(s) / intervention(s)

JDQ443

JDQ443: JDQ443 per os (PO) 200 mg twice a day continuously

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Key Inclusion criteria * Histologically confirmed locally advanced (stage IIIb/IIIc not eligible for definitive chemoradiation or surgical resection with curative intent) or metastatic (stage IV) NSCLC without previous systemic treatment for metastatic disease. Prior (neo)adjuvant treatment with chemotherapy and/or immunotherapy, or prior radiotherapy administered sequentially or concomitantly with chemotherapy and/or immunotherapy for localized or locally advanced disease are accepted if the time between therapy completion and enrollment is \> 12 months. * Presence of a KRAS G12C mutation (all participants) and: * Cohort A: PD-L1 expression \< 1%, regardless of STK11 mutation status * Cohort B: PD-L1 expression ≥ 1% and an STK11 co-mutation * At least one measurable lesion per RECIST 1.1. * ECOG performance status ≤ 1. * Participants capable of swallowing study medication. Key Exclusion criteria * Participants whose tumors harbor an EGFR-sensitizing mutation and/or ALK rearrangement by local laboratory testing. Participants with other known druggable alterations will be excluded, if required by local guidelines * Previous use of a KRAS G12C inhibitor or previous systemic treatment for metastatic NSCLC. * A medical condition that results in increased photosensitivity (i.e., solar urticaria, lupus erythematosus, etc.). * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Participants who are taking a prohibited medication (strong CYP3A inducers) that cannot be discontinued at least seven days prior to the first dose of study treatment and for the duration of the study. Other inclusion/exclusion criteria may apply

Primary outcome measure(s)

Trial sites (45)

FacilityCityRegionStatus
The Brown University Oncology Group Providence Rhode Island
Novartis Investigative Site Pilar Buenos Aires
Novartis Investigative Site Córdoba Córdoba Province
Novartis Investigative Site Buenos Aires Argentina
Novartis Investigative Site Córdoba Argentina
Novartis Investigative Site Feldkirch Austria
Novartis Investigative Site Wels Austria
Novartis Investigative Site Sint-Niklaas Oost Vlaanderen
Novartis Investigative Site Roeselare West-Vlaanderen
Novartis Investigative Site Salvador Estado de Bahia
Novartis Investigative Site Belo Horizonte Brazil
Novartis Investigative Site Rio de Janeiro Brazil
Novartis Investigative Site Wuhan Hubei
Novartis Investigative Site Changsha Hunan
Novartis Investigative Site Beijing China
Novartis Investigative Site Marseille Bouches Du Rhone
Novartis Investigative Site Bron France
Novartis Investigative Site Montpellier France
Novartis Investigative Site Saint-Herblain France
Novartis Investigative Site Strasbourg France
Novartis Investigative Site Kempten (Allgäu) Bavaria
Novartis Investigative Site Halle Saxony-Anhalt
Novartis Investigative Site Hamburg Germany
Novartis Investigative Site Oldenburg Germany
Novartis Investigative Site Tübingen Germany
Novartis Investigative Site Athens Greece
Novartis Investigative Site Mátraháza Hungary
Novartis Investigative Site Thellakom Kottayam Kerala
Novartis Investigative Site Varanasi Uttar Pradesh
Novartis Investigative Site Bari BA
Novartis Investigative Site Rozzano MI
Novartis Investigative Site Roma RM
Novartis Investigative Site Orbassano TO
Novartis Investigative Site George Town Pulau Pinang
Novartis Investigative Site Kuching Sarawak
Novartis Investigative Site Breda North Brabant
Novartis Investigative Site Leeuwarden Provincie Friesland
Novartis Investigative Site Porto Portugal
Novartis Investigative Site Barcelona Spain
Novartis Investigative Site Madrid Spain

+ 5 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in the UK

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 NCT05445843 on ClinicalTrials.gov ↗ ← All trials in the UK