Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Sunvozertinib
- Crizotinib
- Pralsetinib
- Larotrectinib
- Savolitinib
- Pyrotinib
- Dabrafenib+Trametinib
- Glecirasib
- Ensartinib
Treatment groups
120 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov