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

First listed
Aug 21, 2024
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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