Non-small Cell Lung Cancer
Conditions
Interventions
experimental group:Pembrolizumb only as Neoadjuvant Therapy
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male and female age >= 18 years old. 2. Patients with histologically confirmed non-small cell lung cancer (requiring biopsy): (1) Squamous cell carcinoma or non squamous cell carcinoma tissue (note - at least 4 squamous cell carcinoma patients should be included in every 16 to 20 patients included); (2) Diagnostic biopsy specimens should be diagnosed by a specialist pathologist; (3) Tumor biopsy samples can be formalin fixed tissue blocks or 10 5 µ m tissue sections, which will be used for biomarker evaluation (pathologists need to confirm whether the samples are sufficient). These can be preserved samples or, if necessary, new biopsies. 3. Staging - patients with NSCLC who are likely to be cured after the first complete resection need to be evaluated by a specialist surgeon. This includes clinical stage II and stage III a. 4. ECoG score data 0-1. 5. Subjects with good organ function: (1) WBC >= 2000 / mm3; (2) Absolute neutrophil count (ANC) >= 1000 / mm3; (3) Platelet count >= 100000 / mm3; (4) Hemoglobin >= 9g / dl; (5) Creatinine = 92% at rest and walking (no oxygen inhalation). 6. Patients understand the research protocol and its requirements, the existing risks and possible adverse reactions, and are able and willing to sign informed consent. Written informed consent signed and dated by the patient in accordance with regulations and institutional guidelines and approved by the Ethics Committee (IRB / IEC) must be obtained before implementing any program related procedures that are not part of normal patient care. Subjects must be able to report adverse events (AE), understand the drug administration protocol and use drugs to control AE. 7. Patients with an estimated survival time of 12 weeks or more; 8. Patients who have not received chemotherapy or other targeted therapy in the past; 9. The patients who voluntarily joined the study signed the informed consent form (ICF) with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with active, known or suspected autoimmune diseases. Subjects with vitiligo, type I diabetes, residual hypothyroidism requiring only hormone replacement due to autoimmune thyroiditis, or disease that is not expected to recur without an external trigger were allowed to register. Systemic treatment with corticosteroids (> 10 mg prednisone equivalent per day) or other immunosuppressive drugs is required within 14 days after the first administration. In the absence of active autoimmune disease, inhaled or topical steroid and adrenal replacement steroid doses are permitted. 2. Patients who use chemotherapy or any other cancer therapy during the preoperative period. 3. Subjects with active concurrent malignancies were excluded, i.e. cancers other than NSCLC (except non melanoma skin cancer, bladder cancer in situ, gastric cancer, breast cancer, colon cancer or cervical cancer / dysplasia). 4. Subjects with brain metastases were excluded from this study, and all patients should have brain imaging (enhanced MRI or CT brain imaging) before inclusion. 5. Subjects with history of interstitial lung disease. 6. Positive detection of hepatitis B surface antigen or hepatitis C RNA in patients with active systemic infection requiring treatment. 7. Subjects with a history of allergy to the components of the study drug. 8. Pregnant or lactating women. 9. Patients previously treated with anti-PD-1, anti-PD-L1, anti-pdl-2 or anti-CTLA-4 antibodies (or any other antibodies targeting T cell co regulatory pathways). 10. The researchers believe that under the existing medical conditions, the use of research drugs may make the subject dangerous or obscure the explanation of toxicity or adverse events. 11. Patients with central tumor whose distance from tumor focus to large blood vessel was less than or equal to 5 mm, or with local large blood vessel invasion, or with obvious cavitary / necrotic tumor in lung; 12. Patients with abnormal coagulation function (INR > 1.5 x ULN, APTT > 1.5 x ULN) have bleeding tendency or are receiving thrombolytic, anticoagulant or antiplatelet therapy, including obvious hemoptysis / hemoptysis of two teaspoons or more per day within 2 months, significant clinical bleeding symptoms or definite bleeding tendency within 3 months, The occurrence of arteriovenous thrombosis within 12 months or other known hereditary or acquired bleeding and thrombotic tendency; 13. Patients with hypertension who can not be reduced to normal range after antihypertensive drug treatment (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 14. Patients with long-term unhealed wounds / fractures; 15. Patients with cardiovascular diseases above grade II or poorly controlled; 16. Patients with small cell lung cancer (including small cell lung cancer and non-small cell lung cancer).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MPR;Event of peri-operative adverse effects;Surgical feasibility rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Disease-Free Survival;Objective Response Rate;Nodal Downstaging at Surgery; | — |
Countries
China
Contacts
Public ContactSong Xu
Tianjin Medical University General Hospital
Outcome results
None listed