NSCLC
Conditions
Brief summary
Neoadjuvant therapy with penpulimab combined with anlotinib;with surgery within 4-6 weeks after drug withdrawal;Adjuvant therapy within 4-12 weeks after surgery
Detailed description
1. Neoadjuvant therapy with penpulimab combined with anlotinib penpulimab: fixed dose of 200 mg, administered on the first day of each cycle, repeated every 3 weeks; Anlotinib: 12 mg, administered on days 1-14, orally once a day, about half an hour before breakfast (the daily dose should be as much as possible), taken with warm water, and repeated every 3 weeks. 2. operation treatment: Each subject will receive 3 cycles of study treatment, with surgery within 4-6 weeks after drug withdrawal. 3. Suggested dosing regimen in the adjuvant therapy phase: It is recommended to give patients corresponding adjuvant therapy after surgery, and the specific adjuvant therapy plan will be formulated by the investigator according to the individual situation of the patient. The postoperative adjuvant therapy in this protocol is for reference only: complete pre-dose examination within 4-12 weeks after surgery, and conduct pre-administration evaluation of adjuvant therapy; use platinum-based chemotherapy (cisplatin: 75mg/m2, d1, Q3W, 4 cycles; in combination with docetaxel: 75mg/m2, d1, Q3W, 4 cycles, or in combination with pemetrexed: 500mg/m2, d1, Q3W, 4 cycles (for non-squamous cell carcinoma only) row 4 cycle of adjuvant therapy; then continued adjuvant single-agent penicillimab (200 mg, day 1, Q3W) for 1 year or until disease progression. If the following conditions occur during the treatment, such as the subject's disease progression, drug toxicity and side effects intolerable, withdrawal of informed consent, etc., the patient will terminate the treatment. During the trial, the efficacy indicators and safety indicators were observed.
Interventions
DRUGpenpulimab combined with anlotinib
penpulimab: fixed dose of 200 mg, administered on the first day of each cycle, repeated every 3 weeks; Anlotinib: 12 mg, administered on days 1-14, orally once a day, about half an hour before breakfast (the daily dose should be as much as possible), taken with warm water, and repeated every 3 weeks
Sponsors
Tang-Du Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 1\. 18 years old ≤ age ≤ 70 years old, male or female; * 2\. ECOG score 0\ 1 points; * 3\. Patients with non-small cell lung cancer diagnosed by pathology (histology or cytology) (according to WHO 2015 classification); * 4\. Patients with positive PD-L1 expression (PD-L1≥1%); * 5\. According to the eighth edition of clinical tumor TNM staging, the subjects are patients with resectable stage II-IIIB (IIIB only T3N2) non-small cell lung cancer; * 6\. Have measurable lesions (according to RECIST 1.1 standard, the long diameter of CT scan of tumor lesions is ≥10mm, and the short diameter of CT scan of lymph node lesions is ≥15mm;); * 7\. Those who were initially diagnosed with non-small cell lung cancer before enrollment and had not undergone radiotherapy, chemotherapy, surgery and targeted therapy; * 8\. The subject must have sufficient cardiopulmonary function for the intended lung resection; * 9\. The function of major organs is normal, that is, the following criteria are met: 1. Routine blood examination must meet the following requirements (no blood transfusion, no hematopoietic factor and no drug correction within 14 days): 1. ANC ≥1.5×109/L; 2. PLT ≥ 100×109/L; 3. HB ≥ 90 g/L; 2. The biochemical examination must meet the following standards: 1. TBIL≤1.5×ULN; 2. ALT, AST≤2.5×ULN 3. Serum creatinine sCr≤1.5×ULN, endogenous creatinine clearance rate≥50mL/min (Cockcroft-Gault formula); 4. ALB ≥30 g/L 3. Coagulation function must meet: INR≤1.5×ULN and APTT≤1.5×ULN; * 10\. Normal lung function or mild to moderate abnormality, and can tolerate surgery; 1. VC%\>60% 2. FEV1\>1.2L, FEV1%\>40% 3. DLco\>40% * 11\. Female subjects of childbearing age must undergo a serum pregnancy test within 3 days before starting the study drug, and the result is negative, and are willing to use a medically approved high-efficiency contraceptive during the study and within 3 months after the last dose of the study drug Measures (eg: IUD, contraceptives, or condoms); for male subjects whose partners are females of childbearing age, surgical sterilization, or consent to use an effective method of contraception.
Exclusion criteria
* 1\. Target disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response, pCR | 12months | To evaluate the pathological complete response rate (pCR) of pembrolizumab combined with anlotinib neoadjuvant therapy for resectable non-small cell lung cancer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major pathologic response, MPR | 12months | Evaluate the major pathologic response rate (MPR) |
| Disease free survival,DFS | 12months | defined as, according to the RECIST1.1 criteria, the time between subjects from enrollment to disease recurrence or death (for any reason) |
Contacts
Primary ContactJie Lei
Backup ContactJie Lei
Outcome results
None listed