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.
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Overall Response Rate (ORR) as Determined by the Investigator in Cohort A — Up to approximately 22 months
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.
Trial sites (45)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Spain
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 Spain