Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06563999

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

Led by Sun Yat-sen University · Updated on 2026-04-21

120

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Treatment-naive unresectable stage III NSCLC according to AJCC 8th edition
  • Squamous or non-squamous NSCLC histology
  • Presence of a rare mutation based on NGS including EGFR exon20ins, ROS1 fusion, RET fusion, NTRK fusion, MET 14 exon, HER2, BRAF V600E, KRAS G12C, or ALK fusion
  • Absence of EGFR exon 19 deletions or exon 21 L858R activating mutation
  • Male or female aged 18 to 75 years
  • Provision of blood and specimens before and after treatment
  • ECOG performance status 0 or 1
  • Adequate hematological function: ANC ≥2.0 x 10^9/L, Platelets ≥100 x 10^9/L, Hemoglobin ≥9 g/dL
  • Adequate liver function: Total bilirubin ≤1.5 x ULN, AST and ALT ≤2.5 x ULN
  • Adequate renal function: Serum creatinine ≤1.25 x ULN or creatinine clearance ≥60 ml/min
  • Female subjects not pregnant or breast-feeding
  • Written informed consent and willingness to comply with study procedures
Not Eligible

You will not qualify if you...

  • Not unresectable stage III disease per investigator
  • Known EGFR sensitive mutations
  • Previous systemic antitumor therapy for NSCLC
  • Untreated eye inflammation or infection or predisposing conditions
  • History of another malignancy within 5 years except certain cured cancers
  • Clinically active interstitial lung disease
  • Known HIV or AIDS
  • Inability to comply with protocol or study procedures
  • Unstable systemic diseases including active infections, uncontrolled hypertension, unstable angina, recent myocardial infarction, serious arrhythmia, hepatic, renal or metabolic disease
  • Serious concomitant systemic disorder compromising study completion
  • Pregnant or nursing women
  • Mixed small cell lung cancer patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

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Research Team

S

Si-Yu Wang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

9

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