Clinical Trials Logo
  1. Home
  2. NSCLC
  3. NCT06054191

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

NSCLC Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06054191
Study type Interventional
Source Sun Yat-sen University
Contact Li Zhang, MD
Phone 86-20-87343458
Email zhangli6@mail.sysu.edu.cn
Status Not yet recruiting
Phase Phase 2
Start date February 1, 2024
Completion date March 1, 2027
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05821933 - RC108 Combine With Furmonertinib With/Without Toripalimab in Patients With EGFR-mutated NSCLC Phase 1/Phase 2
Active, not recruiting NCT03269162 - Postoperative NSCLC Treated With Integrated Medicine Base on Circulating Tumor Cell Detection Phase 3
Recruiting NCT05002270 - JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation Phase 1/Phase 2
Recruiting NCT06315686 - The Dynamic Monitoring of Cerebrospinal Fluid ctDNA Phase 2
Active, not recruiting NCT05059522 - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Phase 3
Recruiting NCT05466149 - Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic NSCLC With EGFR Exon 20 Insertion Phase 2
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Completed NCT03609918 - Comprehensive Analysis of Gene Mutation Profile in Chinese NSCLC Patients by Next-generation Sequencing
Recruiting NCT06043817 - First-In-Human Study of STX-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Phase 1/Phase 2
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Recruiting NCT05078931 - A Study to Evaluate Pembrolizumab Plus Lenvatinib in PD-L1 Positive TKI Resistant NSCLC Patients Phase 2
Not yet recruiting NCT05547737 - Multicenter, Prospective, Real World Study of Camrelizumab in Cross-line Treatment of Non-small Cell Lung Cancer
Not yet recruiting NCT05909137 - Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer
Withdrawn NCT05959473 - EGFR_IUO 3.20 Clinical Study Protocol N/A
Not yet recruiting NCT05005468 - A Phase II Trial of Camrelizumab Combined With Famitinib for Adjuvant Treatment of Stage II-IIIA NSCLC. Phase 2
Recruiting NCT01690390 - Dose Escalation of Icotinib in Advanced Non-small Cell Lung Carcinoma (NSCLC) Patients Evaluated as Stable Disease Phase 2
Completed NCT01852578 - Cabazitaxel in Relapsed and Metastatic NSCLC Phase 2
Active, not recruiting NCT01460472 - Immunotherapy With Racotumomab in Advanced Lung Cancer Phase 3
Completed NCT00702975 - Study of Combination Therapy of Carboplatin -Gemcitabine Plus Bevacizumab Beyond Progression in Patients With Locally Advanced and/or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Not Received Prior Systemic Therapy Phase 2
Completed NCT00866970 - Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia Phase 2