Non Small Cell Lung Cancer
Conditions
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-based chemotherapy with resectable stage II-IIIB non-small cell lung cancer.
Interventions
DRUGAtezolizumab
Pemetrexed (500mg/m2)/Paclitaxel (260mg/m2) Carboplatin (AUC=4-5) Atezolizumab(1200mg) ivgtt, every 21 days Range from 4 cycles
Sponsors
Hunan Province Tumor Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible subjects selected for this study must meet all of the following criteria: 1. Sign written informed consent before implementing any trial-related procedures; 2. Age ≥18 years old and ≤75 years old; No limit on the gender; 3. 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; 4. 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; 5. Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1; 6. 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); 7. ECOG score 0-1; 8. 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; 9. The total lung function can withstand the proposed pneumonectomy surgery according to the surgeon's assessment; 10. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MPR Rate | 1.5 year | Major pathological remissions |
| MRD negative Rate | 1.5 year | Minimal residual disease rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EFS | 1.5 year | event-free survival |
| pCR | 1.5 year | Defined as the proportion of subjects with complete remission (CR), partial remission (PR) and stable disease (SD) to the total subjects |
| OS | 1.5 year | Overall survival time |
| ORR | 1.5 year | Overal response rat |
| DFS | 1.5 year | disease-free survival |
Countries
China
Contacts
Primary ContactYongchang C Zhang, MD
Backup ContactNong C Yang, MD
Outcome results
None listed