Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.
- Conditions
- Lung Cancer Stage IIIMutation
- Registration Number
- NCT06563999
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria:<br><br> - Subjects must have treatment-naive unresectable stage III NSCLC according to the<br> AJCC 8th edition staging;<br><br> - Squamous or non-squamous NSCLC histology;<br><br> - Subjects should have a rare mutation based on NGS, including mutations of EGFR<br> exon20ins, ROS1 fusion, RET fusion, NTRK fusion, MET 14 exon, HER2, BRAF V600E, KRAS<br> G12C, and ALK fusion.<br><br> - Subjects should be without EGFR exon 19 deletions or exon 21 L858R activating<br> mutation;<br><br> - Male and female, aged 18-75 years;<br><br> - Blood and specimens before and after treatment must be provided;<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;<br><br> - Adequate hematological function: Absolute neutrophil count (ANC) =2.0 x 109/L, and<br> Platelet count =100 x 109/L, and Hemoglobin =9 g/dL (may be transfused to maintain<br> or exceed this level);<br><br> - Adequate liver function: Total bilirubin = 1.5 x upper limit of normal (ULN),<br> Aspartate aminotransferase (AST), alanine aminotransferase (ALT) = 2.5 x ULN;<br><br> - Adequate renal function: Serum creatinine = 1.25 x ULN, or = 60 ml/min;<br><br> - Female subjects should not be pregnant or breast-feeding;<br><br> - Written informed consent provided. Being willing and able to comply with the visits,<br> treatment plan, laboratory examinations and other study procedures scheduled in the<br> study.<br><br>Exclusion Criteria:<br><br> - Not unresectable stage III disease according to the investigator;<br><br> - Subjects with known EGFR sensitive mutations;<br><br> - Previous treatment with systemic antitumor therapy for NSCLC;<br><br> - Eye inflammation or eye infection not fully treated or conditions predisposing the<br> subject to this.<br><br> - History of another malignancy in the last 5 years with the exception of the<br> following: other malignancies cured by surgery alone and having a continuous<br> disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the<br> skin and cured in situ carcinoma of the uterine cervix are permitted.<br><br> - Evidence of clinically active interstitial lung disease;<br><br> - Known history of testing positive for human immunodeficiency virus (HIV) or known<br> acquired immunodeficiency syndrome (AIDS);<br><br> - Inability to comply with protocol or study procedures;<br><br> - Any unstable systemic disease (including active infection, active tuberculosis<br> uncontrolled hypertension, unstable angina, congestive heart failure, myocardial<br> infarction within the previous year, serious cardiac arrhythmia requiring<br> medication, hepatic, renal, or metabolic disease);<br><br> - A serious concomitant systemic disorder that, in the opinion of the investigator,<br> would compromise the patient's ability to complete the study and may confuse the<br> study results;<br><br> - Women who are pregnant or nursing.<br><br> - Ingredients mixed with small cell lung cancer patients.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Resectability rate
- Secondary Outcome Measures
Name Time Method Adverse Events;Two-year disease-free survival;Two-year overall survival;Number of participants with perioperative complications