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KontRASt-06: An Open-label Phase II Trial Evaluating the Activity 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 expression ≥ 1% and an STK11 co-mutation (cohort B).
This is a non-randomized, open-label, single-arm, multicenter, phase II study evaluating the antitumor activity and safety of JDQ443 single-agent as first-line treatment for participants with locally advanced or metastatic KRAS G12C-mutated NSCLC. The study will have 2 non-comparative cohorts that will recruit participants in parallel according to the following characteristics: * Cohort A: participants whose tumors harbor a KRAS G12C mutation and a PD-L1 expression \< 1%, regardless of STK11 mutation status. * Cohort B: participants whose tumors harbor a KRAS G12C mutation, a PD-L1 expression ≥ 1% and an STK11 co-mutation. The study treatment begins on Cycle 1 Day 1 (C1D1) with the first administration of JDQ443. One treatment cycle consists of 21 (±3) days. Study completion is defined as the earliest occurrence of one of the following: * The last participant completes last study visit (and the assessments associated with this visit have been documented and followed-up appropriately by the Investigator), dies, withdraws consent, or is lost to follow-up, whichever comes first.\] * In the event of an early study termination decision, the date of that decision. * Another clinical study becomes available that can continue to provide JDQ443 to study participants and all participants with ongoing treatment are transferred to that clinical study.
Age
18 - 100 years
Sex
ALL
Healthy Volunteers
No
The Brown University Oncology Group
Providence, Rhode Island, United States
Novartis Investigative Site
Pilar, Buenos Aires, Argentina
Novartis Investigative Site
Buenos Aires, Argentina
Novartis Investigative Site
Córdoba, Argentina
Novartis Investigative Site
Córdoba, Argentina
Novartis Investigative Site
Feldkirch, Austria
Novartis Investigative Site
Wels, Austria
Novartis Investigative Site
Sint-Niklaas, Oost Vlaanderen, Belgium
Novartis Investigative Site
Roeselare, West-Vlaanderen, Belgium
Novartis Investigative Site
Salvador, Estado de Bahia, Brazil
Start Date
December 6, 2022
Primary Completion Date
November 4, 2024
Completion Date
December 31, 2026
Last Updated
February 13, 2026
95
ACTUAL participants
JDQ443
DRUG
Lead Sponsor
Novartis Pharmaceuticals
Data Source & Attribution
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