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

NCT06563999 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

  • Lung Cancer Stage III
  • Mutation

Interventions

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.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Si-Yu Wang, MD · Sun Yat-Sen University Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2027-11-01
Completion
2029-11-01

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06563999 on ClinicalTrials.gov