NCT06563999
Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.
Recruiting · Phase 2 · Sun Yat-sen University · registry updated 2026-04-21
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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;
Exclusion
- 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;