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

NCT06054191 | Not Yet Recruiting Phase 2

• 1 other identifier: B2023-331-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 mutations.

Conditions

NSCLC; BRAF V600 Mutation; MET Exon 14 Mutation

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (pCR) rate

  pCR rate is defined as the percentage of participants with no residual viable tumor cells.

  up to 2 years

Secondary Outcomes (4)

• Major pathological response (MPR) rate

  up to 2 years

• Event-free survival (EFS)

  up to 3 years

• Disease-free survival (DFS)

  up to 3 years

• Overall survival (OS)

  up to 3 years

Study Arms (2)

Cohort 1: BRAF V600 mutation

EXPERIMENTAL

Dabrafenib + Trametinib

Drug: Dabrafenib + Trametinib

Cohort 2: MET ex14 skip mutation

EXPERIMENTAL

Capmatinib

Drug: Capmatinib

Interventions

Dabrafenib + Trametinib DRUG

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

Cohort 1: BRAF V600 mutation

Capmatinib DRUG

Capmatinib 400mg BID/（2 cycles）

Cohort 2: MET ex14 skip mutation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer Center of Sun-Yat Sen University

Guangzhou, Guangdong, China

Location

MeSH Terms

Interventions

dabrafenib; trametinib; capmatinib

Central Study Contacts

Li Zhang, MD

CONTACT

86-20-87343458; zhangli6@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 26, 2023
• Study Start: February 1, 2024
• Primary Completion: March 1, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

CN (1)