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Small Molecule Inhibitor

JDQ443 for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cohort B: PD-L1 expression ≥ 1% and an STK11 co-mutation
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
Must not have
Know active (unstable/symptomatic) central nervous system (CNS) metastases and/or carcinomatous meningitis
Participants whose tumors harbor an EGFR-sensitizing mutation and/or ALK rearrangement by local laboratory testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to death, up to approximately 36 months
Awards & highlights

Summary

This trial studies a new drug to treat NSCLC with KRAS mutations & low/high PD-L1 expression.

Who is the study for?
This trial is for adults with advanced non-small cell lung cancer (NSCLC) that has a specific mutation (KRAS G12C). Participants must have a PD-L1 expression level below 1% or above 1% with an STK11 co-mutation, and should not have had previous systemic treatment for metastatic NSCLC. They need to be able to swallow pills, have at least one measurable tumor lesion, and be in good physical condition.
What is being tested?
The study tests JDQ443 as the first-line treatment for NSCLC patients with KRAS G12C mutations. It's divided into two groups based on their PD-L1 expression levels: one group has less than 1%, while the other has more than 1% plus an STK11 mutation. The drug's effectiveness and safety are being evaluated.
What are the potential side effects?
While specific side effects of JDQ443 aren't listed, common ones from similar treatments include nausea, fatigue, skin reactions like rash or itchiness, diarrhea or constipation, liver function changes, and potential increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has PD-L1 expression of 1% or more and an STK11 mutation.
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My lung cancer is advanced but hasn't been treated with systemic therapy for its metastatic stage.
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My cancer has PD-L1 expression under 1%, STK11 mutation status doesn't matter.
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I can swallow pills.
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My cancer has a KRAS G12C mutation.
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I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have active brain metastases or carcinomatous meningitis.
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My cancer has EGFR mutation or ALK rearrangement.
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I have a condition that makes my skin extra sensitive to sunlight.
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I am not taking any strong medications that can't be stopped a week before starting the study treatment.
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I have used a KRAS G12C inhibitor or had systemic treatment for metastatic NSCLC.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to death, up to approximately 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to death, up to approximately 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall response rate (ORR) by blinded independent review committee (BIRC) in cohort A
Secondary study objectives
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of JDQ443 in plasma
Area Under the Curve From Time Zero to the last measurable concentration sampling time at steady-state (AUClastss) of JDQ443 in plasma
Chain from baseline in NSCLC-SAQ
+24 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort B- PD-L1≥ 1% and STK11 mutationExperimental Treatment1 Intervention
Participants whose tumors harbor a KRAS G12C mutation, a PD-L1 expression ≥ 1% and an STK11 co-mutation.
Group II: Cohort A- PD-L1<1%Experimental Treatment1 Intervention
Participants whose tumors harbor a KRAS G12C mutation and a PD-L1 expression \<1%, regardless of STK11 mutation status.

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Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,889 Previous Clinical Trials
4,201,908 Total Patients Enrolled
~52 spots leftby Nov 2026
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