Study of Efficacy and Safety of… · NCT05445843

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. is a phase 2 interventional study registered as NCT05445843 by Novartis Pharmaceuticals, with 95 participants enrolled, started 2022-12-06 and due to reach its primary completion in 2024-11-04. Interventions recorded: JDQ443. Results have been posted on the registry.

Setting

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.

Phase

Phase 2

Sponsor

Novartis Pharmaceuticals

Registry

NCT05445843

Started

2022-12-06

Reported

2025

Enrolled

95 enrolled

Outcomes

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In plain words

What these results mean for people, not percentages

95 enrolled

Overall Response Rate (ORR) as Determined by the Investigator in Cohort Aprimaryresponse endpoint

29.2 out of 100 people had their tumour shrink with Cohort A- PD-L1<1%.

There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
These results apply to the people the trial enrolled: 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. People in a different situation may not see the same effect.
The trial selected people by a biomarker (KRAS); the result should not be assumed for people whose cancer does not have it.
Only 95 people took part, so the numbers are less certain than in a large trial.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

95 enrolled.

Overall Response Rate (ORR) as Determined by the Investigator in Cohort Aprimary

Cohort A- PD-L1<1%29.2 of 100

n = 72

Download

95% CI 19.0 to 41.1; Figures from the ClinicalTrials.gov results section (first posted 2025-10-09), not from a publication

Source

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Overall Response Rate (ORR) as Determined by the Investigator in Cohort Aprimary	Cohort A- PD-L1<1%	72	29.2%	-	-	link

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cancers

KRAS G12C-mutant non-small-cell lung cancer Non-small-cell lung cancer

targets

STK11

drugs

Phase 3small molecule

JDQ443

companies

Advanced Accelerator Applications (Novartis)Novartis

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.

Outcomes

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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.

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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.

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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.

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