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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Sunvozertinib
Drug300 mg orally once a day, 28 days as one cycle.
Crizotinib
Drug300 mg orally once a day, 28 days as one cycle.
Pralsetinib
Drug400 mg orally once a day, 28 days as one cycle.
Larotrectinib
Drug100 mg orally twice daily, 28 days as one cycle.
Savolitinib
Drug600 mg or 400 mg (weight \<50 kg) orally once a day, 28 days as one cycle.
Pyrotinib
Drug400 mg orally once a day, 28 days as one cycle.
Dabrafenib+Trametinib
DrugDabrafenib 150 mg orally twice daily, 28 days as one cycle. Trametinib 150 mg orally twice daily, 28 days as one cycle.
Glecirasib
Drug800 mg daily orally, 28 days as one cycle.
Ensartinib
Drug225 mg daily orally, 28 days as one cycle.
Treatment groups
120 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Group A: Treatment 1-SunvozertinibExperimental treatment 1 intervention
Group B: Treatment 2-CrizotinibExperimental treatment 1 intervention
Group C: Treatment 3-PralsetinibExperimental treatment 1 intervention
Group D: Treatment 4-LarotrectinibExperimental treatment 1 intervention
Group E: Treatment 5-SavolitinibExperimental treatment 1 intervention
Group F: Treatment 6-PyrotinibExperimental treatment 1 intervention
Group G: Treatment 7-Dabrafenib+TrametinibExperimental treatment 1 intervention
Group H: Treatment 8-GlecirasibExperimental treatment 1 intervention
Group I: Treatment 9-EnsartinibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Resectability rate
Time frame
Baseline to 6 monthsSecondary outcomes
1
Adverse Events
Adverse Events were monitored according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
Time frame
Baseline to 24 months2
Two-year disease-free survival
Disease-free survival was assessed from randomization to disease recurrence or death as a result of any cause.
Time frame
2 years after the last patient is randomized3
Two-year overall survival
Overall survival was assessed from randomization to death as a result of any cause.
Time frame
2 years after the last patient is randomized4
Number of participants with perioperative complications
Time frame
Baseline to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov