Starting soon
Phase 2
Neoadjuvant and Adjuvant Targeted Treatment in NSCLC With BRAF V600 or MET Exon 14 Mutations
Condition(s) studied
NSCLCBRAF V600 MutationMET Exon 14 Mutation
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
| Cancer Center of Sun-Yat Sen University |
Guangzhou |
Guangdong |
|
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