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JDQ443 for KRAS G12C NSCLC Brain Metastases

NCT05999357 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-05-29

No results posted yet for this study

Summary

The goal of this phase II clinical trial is to evaluate the intracranial efficacy of JDQ443, a KRAS G12C inhibitor in patients with KRAS G12C+ NSCLC and brain metastases (cohort A: asymptomatic, untreated brain metastases, cohort B: asymptomatic, treated brain metastases). The main question it aims to answer is to evaluate the intracranial efficacy, according to RANO-BM criteria, in patients with asymptomatic and untreated brain metastases.

Participants will receive JDQ443 200 mg BID until unacceptable toxicity or disease progression.

Conditions

  • Non Small Cell Lung Cancer Metastatic
  • Brain Metastases, Adult
  • KRAS G12C

Interventions

DRUG

JDQ443

JDQ443 tablets, orally administered

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Lizza Hendriks, MD, PhD · Maastricht University Medical Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2027-08-31
Completion
2028-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05999357 on ClinicalTrials.gov