NCT06054191

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

Not yet recruiting Phase 2 Last updated 10 October 2023

What this trial tests

Phase 2 trial testing Dabrafenib + Trametinib in NSCLC in 40 participants. Not yet recruiting.

Timeline

1 February 2024

Primary endpoint
1 March 2025

1 March 2027

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 February 2024
Primary completion	1 March 2025
Estimated completion	1 March 2027
Sites	1 location across China

Drugs / interventions tested

• Dabrafenib + Trametinib — full drug profile →
• Capmatinib (CAPMATINIB) — full drug profile →

Conditions studied

• NSCLC — all drugs for NSCLC →
• BRAF V600 Mutation — all drugs for BRAF V600 Mutation →
• MET Exon 14 Mutation — all drugs for MET Exon 14 Mutation →

Sponsor

Sun Yat-sen University

Who can join

18 and older, any sex, with NSCLC or BRAF V600 Mutation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Management of Non-Metastatic Non-Small Cell Lung Cancer (NSCLC) with Driver Gene Alterations: An Evolving Scenario.
   Fuorivia V, Attili I, Corvaja C, Asnaghi R, et al · · 2024 · cited 7× · PMID 39330007 · DOI 10.3390/curroncol31090379
2. Perioperative Strategies in Resectable Non-Squamous Non-Small Cell Lung Cancer with EGFR Mutations and ALK Rearrangement.
   Petrella F, Cara A, Cassina EM, Degiovanni S, et al · · 2025 · cited 2× · PMID 40507325 · DOI 10.3390/cancers17111844
3. Navigating Therapeutic Challenges in BRAF-Mutated NSCLC: Non-V600 Mutations, Immunotherapy, and Overcoming Resistance.
   Bortolot M, Torresan S, De Carlo E, Bertoli E, et al · · 2024 · cited 2× · PMID 39684685 · DOI 10.3390/ijms252312972
4. Targeting MET in non-small cell lung cancer brain metastases: from molecular mechanism to precision therapy.
   Wang X, Chi Y, Mu F, Mao H, et al · · 2026 · PMID 41981677 · DOI 10.1186/s12967-026-08077-2
5. Targeting rare oncogenic mutations in resectable non-small cell lung cancer: emerging perioperative strategies.
   Hao S, Zhao S, Shi L, Zhong L, et al · · 2026 · PMID 41816478 · DOI 10.21037/jtd-2025-aw-2202
6. Neoadjuvant, Adjuvant and Perioperative Treatment in Early-Stage Non-Small Cell Lung Cancer (NSCLC) with Actionable Genomic Alterations: Current Landscape and Future Perspectives.
   Koutoukoglou P, Mountzios G. · · 2026 · PMID 41681965 · DOI 10.3390/cancers18030493
7. The Evolving Interplay Between Targeted Therapy and Surgery for Resectable Lung Cancer.
   Yin V, Antonoff MB. · · 2025 · PMID 41228366 · DOI 10.3390/cancers17213575
8. Neoadjuvant tepotinib in stage IIB N0 non-small cell lung carcinoma with <i>MET</i> exon 14 skipping mutation: a case report and review of the literature.
   Reyes A, Pharaon R, Mohanty A, Kim J, et al · · 2025 · PMID 40535068 · DOI 10.21037/tlcr-2024-1197