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Not yet recruiting NCT06054191

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

Phase II Interventional NSCLC BRAF V600 Mutation MET Exon 14 Mutation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dabrafenib + Trametinib, Capmatinib.
Who it may be relevant to
Registry conditions: NSCLC, BRAF V600 Mutation, MET Exon 14 Mutation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Phase II, Two Parallel Group Study of Neoadjuvant and Adjuvant Targeted Treatment in NSCLC With BRAF V600 or MET Exon 14 Mutations

Overview

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.

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 mutations. Eligible patients with BRAF V600 mutations will receive dabrafenib 150mg bid plus trametinib 2mg qd for 8 weeks before a surgical resection (neoadjuvant), and followed by up to 4 cycles of adjuvant chemotherapy, if receive adjuvant chemotherapy, up to four cycles, chemo regimen according to investigators' choice, and up to 2 years of adjuvant targeted therapy with dabrafenib plus trametinib. For patients with MET exon14 mutations, they will receive capmatinib 400mg bid for 8 weeks before surgery (neoadjuvant), followed by up to 4 cycles of adjuvant chemotherapy, about adjuvant chemotherapy same as BRAF V600 group, and up to 2 years of adjuvant targeted therapy with capmatinib post-surgery. During treatment, patients will visit their physicians regularly for disease and safety assessment. After the end of treatment, survival follow-up will be conducted every 3 months for up to 3 years. Approximately 40 evaluable patients will be enrolled in the study (20 patients in each cohort).

Interventions

  • Drug Dabrafenib + Trametinib
    Dabrafenib 150mg BID + Trametinib 2mg QD/（2 cycles）
  • Drug Capmatinib
    Capmatinib 400mg BID/（2 cycles）

Primary outcome measures

  • Pathological complete response (pCR) rate [Time frame: up to 2 years]
Secondary outcome measures (4)
  • Major pathological response (MPR) rate [Time frame: up to 2 years]
  • Event-free survival (EFS) [Time frame: up to 3 years]
  • Disease-free survival (DFS) [Time frame: up to 3 years]
  • Overall survival (OS) [Time frame: up to 3 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Cancer Center of Sun-Yat Sen University — Guangzhou

Identifiers

NCT: NCT06054191 · B2023-331-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗