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Small Molecule Inhibitor

JDQ443 for Non-Small Cell Lung Cancer

Q: How deleterious is Cohort A- PD-L1<1% to human health?

There is some evidence of Cohort A- PD-L1&#x3C;1% safety, therefore it has been assigned a rating of 2. It falls under Phase 2 trials as there isn't currently any data to support its efficacy.

Q: What is the current number of participants in this experiment?

Affirmative. Clinicaltrials.gov reveals that this research endeavour, which was originally posted on December 6th 2022, is currently enrolling participants. A total of 120 individuals are needed from 66 different trial sites.

Q: What is the geographic scope of this experiment?

This clinical trial is presently recruiting patients from 66 separate sites, situated across the globe. From Saint Herblain cedex and Wuhan to Paris and other major cities – it's important to select a site closest you for ease of access when participating.

Q: Are there any vacancies available in this trial for participants?

Affirmative. The information housed on clinicaltrials.gov confirms that this trial is still recruiting patients, which it began doing after its original posting date of December 6th 2022. Most recently edited on October 2nd 2023, the study seeks out 120 participants from 66 distinct sites.

Phase 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to death, up to approximately 36 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Select...

I am fully active and can carry on all my pre-disease activities without restriction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to death, up to approximately 36 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall response rate (ORR) by blinded independent review committee (BIRC) in cohort A

Secondary outcome measures

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.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,860 Previous Clinical Trials

4,198,189 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How deleterious is Cohort A- PD-L1<1% to human health?

"There is some evidence of Cohort A- PD-L1<1% safety, therefore it has been assigned a rating of 2. It falls under Phase 2 trials as there isn't currently any data to support its efficacy."

Answered by AI

What is the current number of participants in this experiment?

"Affirmative. Clinicaltrials.gov reveals that this research endeavour, which was originally posted on December 6th 2022, is currently enrolling participants. A total of 120 individuals are needed from 66 different trial sites."

Answered by AI

What is the geographic scope of this experiment?

"This clinical trial is presently recruiting patients from 66 separate sites, situated across the globe. From Saint Herblain cedex and Wuhan to Paris and other major cities – it's important to select a site closest you for ease of access when participating."

Answered by AI

Are there any vacancies available in this trial for participants?

"Affirmative. The information housed on clinicaltrials.gov confirms that this trial is still recruiting patients, which it began doing after its original posting date of December 6th 2022. Most recently edited on October 2nd 2023, the study seeks out 120 participants from 66 distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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.

2022. "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.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05445843.