Status:
NOT_YET_RECRUITING
Neoadjuvant and Adjuvant Targeted Treatment in NSCLC With BRAF V600 or MET Exon 14 Mutations
Lead Sponsor:
Sun Yat-sen University
Conditions:
NSCLC
BRAF V600 Mutation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 mutat...
Detailed Description
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 mutat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06054191
Start Date
February 1 2024
End Date
March 1 2027
Last Update
October 10 2023
Active Locations (1)
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1
Cancer Center of Sun-Yat Sen University
Guangzhou, Guangdong, China