NCT06563999

Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.

Neoadjuvant Umbrella Trial Directed by Next Generation Sequencing for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations (Without EGFR Sensitizing Mutations)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This umbrella trial directed by next generation sequencing (NGS) includes patients with treatment-naive unresectable stage III non-small-cell lung cancer (NSCLC). The aim of the umbrella study is to evaluate the efficacy of induction NGS-directed targeted therapies followed by surgery for stage III NSCLC patients whose tumor harbors a rare mutation.

Detailed description

Stage III non-small-cell lung cancer (NSCLC) patients account for about one-third of newly diagnosed NSCLC, with a large population and strong heterogeneity, posing significant challenges for clinical treatment. Concurrent chemoradiotherapy plus immune checkpoint inhibitors is the recommended therapeutic approach for patients with unresectable stage III non-small cell lung cancer (NSCLC), although surgery offers the chance of cure. However, existing evidence suggests that patients with driver mutation positive NSCLC have limited benefits from immunotherapy. There is still controversy over the definition of 'unresectable', and some stage IIIA and specific stage IIIB-N2 patients may also benefit from comprehensive surgical treatment. Emerging data supports the use of targeted therapies in NSCLC patients with a rare mutation. The aim of this umbrella study is to explore the efficacy of induction next generation sequencing (NGS)-directed targeted therapies followed by surgery for unresectable stage III NSCLC patients whose tumor harbors a rare mutation (Without EGFR Sensitizing Mutations).

Conditions

• Lung Cancer Stage III
• Mutation

Interventions

Type	Name	Description
DRUG	Sunvozertinib	300 mg orally once a day, 28 days as one cycle.
DRUG	Crizotinib	300 mg orally once a day, 28 days as one cycle.
DRUG	Pralsetinib	400 mg orally once a day, 28 days as one cycle.
DRUG	Larotrectinib	100 mg orally twice daily, 28 days as one cycle.
DRUG	Savolitinib	600 mg or 400 mg (weight \<50 kg) orally once a day, 28 days as one cycle.
DRUG	Pyrotinib	400 mg orally once a day, 28 days as one cycle.
DRUG	Dabrafenib+Trametinib	Dabrafenib 150 mg orally twice daily, 28 days as one cycle. Trametinib 150 mg orally twice daily, 28 days as one cycle.
DRUG	Glecirasib	800 mg daily orally, 28 days as one cycle.
DRUG	Ensartinib	225 mg daily orally, 28 days as one cycle.

Timeline

• Start date: 2024-11-01
• Primary completion: 2027-11-01
• Completion: 2029-11-01
• First posted: 2024-08-21
• Last updated: 2024-12-10

Locations

1 site across 1 country: China