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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
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 + TrametinibAll Dabrafenib trials (26) →All Trametinib trials (46) →Capmatinib →

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)

  • Pathological complete response (pCR) rate — up to 2 years
    pCR rate is defined as the percentage of participants with no residual viable tumor cells.

Trial sites (1)

FacilityCityRegionStatus
Cancer Center of Sun-Yat Sen University Guangzhou Guangdong
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