Status:
RECRUITING
Atezolizumab Combined With Platinum-based Chemotherapy as Neoadjuvant Therapy for Patients With Resectable Stage II-IIIB
Lead Sponsor:
Hunan Province Tumor Hospital
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study aimed to evaluate the efficacy, safety, tolerability, feasibility of surgery, and incidence of preoperative and postoperative complications of atezolizumab in combination with platinum-base...
Eligibility Criteria
Inclusion
- Eligible subjects selected for this study must meet all of the following criteria:
- Sign written informed consent before implementing any trial-related procedures;
- Age ≥18 years old and ≤75 years old; No limit on the gender;
- Previously untreated, histologically confirmed resectable stage II, IIIA, IIIB (N2) (AJCC stage VIII) NSCLC; cTNM stage can be confirmed by PET-CT or pathological biopsy; resectable stage II non-small cell lung cancer is defined as radical resection as assessed by a qualified thoracic surgeon; resectable is resectable and potentially resectable as defined by the Expert Consensus on Multidisciplinary Diagnosis and Treatment of Stage III Non-small Cell Lung Cancer (2019 version); resectable includes IIIA (N0-1), some single-station mediastinal lymph node metastases with N2 and some T4 (satellite nodules present in adjacent lobes) N1; potentially resectable includes some stage IIIA and IIIB, including single-station N2 mediastinal lymph node short diameter \< 3 cm stage IIIA NSCLC, potentially resectable T3 or T4 central tumors; Solid/solid pulmonary nodules, not pure ground-glass opacity (GGO), are strongly recommended for pathological puncture verification;
- Patients diagnosed with squamous cell carcinoma do not require genetic testing, and if they test positive for EGFR, ALK or ROS1, they are considered as exclusion criteria; if they are adenocarcinoma, they must undergo genetic testing containing at least EGFR, ALK and ROS1, and the acceptable detection method is ARMS or NGS, of which NGS is a cFDA-approved kit;
- Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1;
- Twenty tissue sections (4-6 microns in thickness) should be submitted before enrollment for biomarker evaluation (tumor tissue samples must be fresh or archival samples obtained within 3 months before enrollment; fresh tissues must be biopsy specimens by hollow needle aspiration, resection or incision);
- ECOG score 0-1;
- Good organ function: (1) hematology: absolute neutrophil count (ANC) ≥ 1500/μL; platelets ≥ 100,000/μL; hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L; (2) kidney: serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance (CrCl) ≥ 60 mL/min (using the Cock-Gault formula); (3) liver: total bilirubin ≤ 1.5 × ULN or for subjects with total bilirubin levels \> 1.5 × ULN, direct bilirubin is within normal limits; AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN; (4) endocrine system: thyroid stimulating hormone (TSH) is within normal limits. Note: If TSH is not within normal range at baseline, if T3 and free T4 are within normal range, then the subject can still meet the inclusion criteria; (5) Coagulation function: international normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN, except: subjects receiving anticoagulant therapy, as long as PT or aPTT is within the proposed use range of anticoagulant drugs; (6) Cardiac function tests: baseline ECG showed no PR interval prolongation or atrioventricular block;
- The total lung function can withstand the proposed pneumonectomy surgery according to the surgeon's assessment;
- Women should agree to use contraceptive measures (such as intrauterine device (IUD), contraceptives or condoms) during the study and within 6 months after the end of the study; serum or urine pregnancy test is negative within 7 days before study entry, and must be non-lactating patients; men should agree to use contraceptive measures during the study and within 6 months after the end of the study period.
Exclusion
- Subjects who meet the following criteria cannot be selected for this study:
- Histopathology is neuroendocrine carcinoma and sarcomatoid tumor；
- The presence of locally advanced unresectable or metastatic disease; unresectable including stage III non-small cell lung cancer multidisciplinary diagnosis and treatment expert consensus (2019 version) defined unresectable, including partial IIIA, IIIB and all IIIC, usually including single-station N2 mediastinal lymph nodes short diameter ≥ 3 cm or multi-station lymph nodes fused into a mass (CT lymph nodes short diameter ≥ 2 cm) N2, invading the esophagus, heart, aorta, pulmonary veins T4 and all N3;
- Subjects with known EGFR mutations or ALK, ROS1 translocations, non-squamous cell carcinoma subjects need to clarify the EGFR, ALK and ROS1 mutation status；
- Early stage NSCLC previously treated with systemic anticancer therapy, including treatment with investigational agents；
- History of (non-infectious) pneumonia/interstitial lung disease requiring steroid therapy, or current pneumonia/interstitial lung disease requiring steroid therapy；
- Known history of active tuberculosis;
- Known active infection requiring systemic treatment;
- Any known or suspected autoimmune disease or immunodeficiency subjects, except: patients with a history of hypothyroidism, if hormone therapy is not required, or are receiving physiological doses of hormone replacement therapy; subjects with stable type I diabetes whose blood glucose is controlled;
- Subjects with active hepatitis B (defined as positive hepatitis B virus surface antigen \[HBsAg\] test results and HBV-DNA test values higher than the upper limit of normal of the laboratory of the study site) or hepatitis C (defined as positive hepatitis C virus surface antibody \[HCsAb\] test results and positive HCV-RNA test results during the screening period);
- Known human immunodeficiency virus (HIV) infection (known HIV antibody positive);
- Live vaccines within 30 days prior to the first dose. Including but not limited to the following: mumps, rubella, measles, varicella/herpes zoster (chickenpox), yellow fever, rabies, bacillus Calmette-Guerin (BCG) and typhoid vaccines (inactivated viral vaccines are allowed);
- Have ≥ grade 2 peripheral neuropathy;
- Previous treatment with PD-1/PD-L1 drugs or treatment with another drug targeting T cell receptor (such as CTLA-4, OX-40, etc.);
- Patients with any severe and/or uncontrolled diseases, such as: (1) unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months before randomization, severe uncontrolled arrhythmia; patients with unsatisfactory blood pressure control (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg); (2) active or uncontrolled severe infection; (3) liver diseases such as cirrhosis, decompensated liver disease, chronic active hepatitis; (4) poor control of diabetes (fasting blood glucose (FBG) \> 10 mmol/L); (5) urine routine showed urine protein ≥ + +, and confirmed 24-hour urine protein \> 1.0g; (6) a history of psychiatric drug abuse and can not quit or mental disorders;
- Use of immunosuppressive drugs 2 times before the first study drug treatment, excluding topical glucocorticoids or systemic glucocorticoids no more than 10 mg/day prednisone or equivalent doses of other glucocorticoids;
- Pregnant or lactating women;
- Prisoners who are unlawfully incarcerated or compulsorily detained for non-mental illness or physical (such as infectious diseases) diseases;
- Patients with bleeding tendency (such as active gastrointestinal ulcers) or treatment with anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues;
- History of allergy to study drug ingredients;
- According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05295212
Start Date
February 1 2023
End Date
July 1 2025
Last Update
September 19 2024
Active Locations (1)
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1
Hunan Cancer hospital
Changsha, Hunan, China