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

Sponsor
Sun Yat-sen University
Study ID
NCT06563999
Phase
PHASE2
Status
Recruiting
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Conditions

  • Lung Cancer Stage III
  • Mutation

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 1, 2024
Status verified
Apr 2026
Primary completion
Nov 1, 2027
Completion
Nov 1, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment 1-Sunvozertinib
    Patients with EGFR exon20ins mutation receive Sunvozertinib 300 mg orally once a day, 28 days as one cycle for 3 cycle.
  • Experimental: Treatment 2-Crizotinib
    Patients with ROS1 fusion mutation receive Crizotinib 250mg orally once a day, 28 days as one cycle for 3 cycle.
  • Experimental: Treatment 3-Pralsetinib
    Patients with RET fusion mutation receive Pralsetinib 400mg orally once a day, 28 days as one cycle for 3 cycle.
  • Experimental: Treatment 4-Larotrectinib
    Patients with NTRK fusion mutation receive Larotrectinib 100 mg orally twice daily, 28 days as one cycle for 3 cycle.
  • Experimental: Treatment 5-Savolitinib
    Patients with MET 14 exon mutation receive Savolitinib 600 mg or 400 mg (weight \<50 kg) orally once a day, 28 days as one cycle for 3 cycle.
  • Experimental: Treatment 6-Pyrotinib
    Patients with HER2 mutation receive Pyrotinib 400 mg orally once a day, 28 days as one cycle for 3 cycle.
  • Experimental: Treatment 7-Dabrafenib+Trametinib
    Patients with BRAF V600E mutation receive Dabrafenib plus Trametinib, 28 days as one cycle for 3 cycle.
  • Experimental: Treatment 8-Glecirasib
    Patients with KRAS G12C mutation receive Glecirasib 800 mg daily orally, 28 days as one cycle for 3 cycle.
  • Experimental: Treatment 9-Ensartinib
    Patients with ALK fusion mutation receive Ensartinib 225 mg daily orally, 28 days as one cycle for 3 cycle.

Primary Outcome Measure

Resectability rate [ Time Frame: Baseline to 6 months ]

Central Contacts

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