RecruitingLung Cancer Stage IIIMutation
Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.
Eligible age
18–75 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: Sun Yat-sen University
You may qualify if…
- ✓ Subjects must have treatment-naive unresectable stage III NSCLC according to the AJCC 8th edition staging;
- ✓ Squamous or non-squamous NSCLC histology;
- ✓ Subjects should have a rare mutation based on NGS, including mutations of EGFR exon20ins, ROS1 fusion, RET fusion, NTRK fusion, MET 14 exon, HER2, BRAF V600E, KRAS G12C, and ALK fusion.
- ✓ Subjects should be without EGFR exon 19 deletions or exon 21 L858R activating mutation;
- ✓ Male and female, aged 18-75 years;
- ✓ Blood and specimens before and after treatment must be provided;
- ✓ Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- ✓ Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level);
You may not qualify if…
- ✕ Not unresectable stage III disease according to the investigator;
- ✕ Subjects with known EGFR sensitive mutations;
- ✕ Previous treatment with systemic antitumor therapy for NSCLC;
- ✕ Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this.
- ✕ History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
- ✕ Evidence of clinically active interstitial lung disease;
- ✕ Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);
- ✕ Inability to comply with protocol or study procedures;
Source: ClinicalTrials.gov · NCT06563999 · last updated 2026-04-21