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Clinical Trials in China / NCT06054191
Starting soon Phase 2

Neoadjuvant and Adjuvant Targeted Treatment in NSCLC With BRAF V600 or MET Exon 14 Mutations

NCT06054191 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Phase 2
Started
2024-02-01
Last updated
2023-10-10

Condition(s) studied

NSCLCBRAF V600 MutationMET Exon 14 Mutation

Investigational drug(s) / intervention(s)

Dabrafenib + TrametinibCapmatinib

Dabrafenib + Trametinib: Dabrafenib 150mg BID + Trametinib 2mg QD/(2 cycles)

Capmatinib: Capmatinib 400mg BID/(2 cycles)

Study summary

This is a Phase II, two parallel group study assessing the efficacy and safety of neoadjuvant and adjuvant targeted therapy in patients with stage IB-IIIA NSCLC harboring BRAF V600 or MET exon14 mutations.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 18 years or older. * Histologically or cytologically diagnosed stage IB-IIIA and selected IIIB (T3N2, T4N2) NSCLC. * Presence of BRAF V600 mutation or METex14 skip mutation in tumor (by PCR or NGS) or blood (by NGS) (pre-treatment biopsy confirmed) in local or other Clinical Laboratory Improvement Amendments (CLIA)-certified lab. * Patients whose pre-surgical lesion is measurable, Eligible for surgical resection and scheduled for surgery within 2 weeks after the last does of neoadjuvant treatment. * ECOG performance-status score of 0 or 1. * No previous anticancer therapy. * Patients with stage II or higher non-small-cell lung cancer (NSCLC) and those with suspected brain metastases should have brain imaging (CT or MRI) prior to enrollment to exclude brain metastasis. * Could provide pretreatment tumor samples available for biomarker analysis. The subject should have good compliance, who would participate in the research voluntarily, and sign the informed consent. Exclusion Criteria: * Patients with unresectable (regardless of stage) or metastatic disease (stage IV) or brain metastases. * Contain neuroendocrine carcinoma tumor histology. * Major surgery within 4 weeks before enrollment, or who have not recovered from side effects of related procedures. * History of current interstitial lung disease or pneumonitis. * Patients with conditions requiring systemic corticosteroids (\>10 mg daily prednisone or equivalent) or immunosuppressive medication within 14 days of the first dose of study drug (Inhaled or topical steroids and adrenal-replacement steroids are allowed). * History of other malignancies within 5 years (excluding basal cell carcinoma of the skin or other carcinoma in situ that has been resected). * Pregnant or lactating women. * Those who are allergic to the research drug or its components. * Subjects who are deemed unable to comply with the study requirements or complete the study. * Those with acquired immunodeficiency syndrome, or any uncontrolled medical disorder, or insufficient function of bone marrow or other important organs.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Cancer Center of Sun-Yat Sen University Guangzhou Guangdong

More Sun Yat-sen University trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06054191 on ClinicalTrials.gov ↗ ← All trials in China