CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 95 enrolled / 95 target
Drug / intervention
JDQ443drug
Likely dose
JDQ443 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05445843
NCT05445843Phase 2ActiveUpdate Overdue (2.2/mo)Completion was 19mo ago
CompareCT.gov

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.

Novartis Pharmaceuticals·interventional·Posted Jul 6, 2022·Updated Jun 11, 2026

In Brief

A Phase 2 clinical trial evaluating JDQ443 for 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. Active but no longer recruiting, targeting 95 participants across 45 sites in 19 countries.

Signals

Enrollment appears stalled

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLocally Advanced or Metastatic KRAS G12C-mutated NSCLC With a PD-L1 Expression <1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation
CountriesArgentina, Austria, Belgium, Brazil, China, France, Germany, Greece, Hungary, India, Italy, Malaysia, Netherlands, Portugal, Spain, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 2Active
20232024202520262027
First PostedJul 6, 2022
Enrollment StartDec 6, 2022
Primary CompletionNov 4, 2024
Study CompletionDec 31, 2026
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 4.0 years ago

Arms & Interventions

Cohort A- PD-L1<1%experimental

Participants whose tumors harbor a KRAS G12C mutation and a PD-L1 expression \< 1%, regardless of STK11 mutation status.

Drug: JDQ443
Cohort B- PD-L1≥ 1% and STK11 mutationexperimental

Participants whose tumors harbor a KRAS G12C mutation, a PD-L1 expression ≥ 1% and an STK11 co-mutation.

Drug: JDQ443

Interventions

JDQ443drug

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