Neoadjuvant and Adjuvant Targeted Treatment in NSCLC With BRAF V600 or MET Exon 14 Mutations
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Dabrafenib + Trametinib
DrugDabrafenib 150mg BID + Trametinib 2mg QD/（2 cycles）
Capmatinib
DrugCapmatinib 400mg BID/（2 cycles）
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Cohort 1: BRAF V600 mutationExperimental treatment 1 intervention
Group B: Cohort 2: MET ex14 skip mutationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pathological complete response (pCR) rate
pCR rate is defined as the percentage of participants with no residual viable tumor cells.
Time frame
up to 2 yearsSecondary outcomes
1
Major pathological response (MPR) rate
MPR rate is defined as the percentage of participants with ≤10% residual viable tumor cells.
Time frame
up to 2 years2
Event-free survival (EFS)
EFS is defined as the time from intervention to the first documented disease progression per RECIST v1.1 that precludes surgery, local or distant disease recurrence, or death from any cause, whichever occurs first.
Time frame
up to 3 years3
Disease-free survival (DFS)
DFS defined as the time from the end of surgery until recurrence or death due to any cause, DFS rate at 12, 24, 36 and 60 months.
Time frame
up to 3 years4
Overall survival (OS)
OS defined as the time between the date of enrollment and the date of death due to any cause.
Time frame
up to 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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