Non-small cell lung cancer
Conditions
Interventions
Targeting therapy (EGFR, ALK, ROS1 or BRAF sensitive mutation):Neoadjuvant therapy stage: targeting therapy for 4-8 weeks, then receive chest CT evaluation. Surgical treatment stage: the patients will
PD-1 antibody + antiangiogenesis drugs (without any mutations above, PD-L1=1%):The neoadjuvant therapy stage: PD-1 antibody 200mg, q3w, 3 weeks per cycle, 2-4 cycles
antiangiogenesis drugs 250 mg, qd, 3 weeks per cycle, 2-4 cycles, then receive chest CT evaluation. Surgical treatment stage: the patients will receive radical surgery. Adjuvant therapy stage:accordin
PD-1 antibody + chemotherapy (without any mutations above, PD-L1<1%):Neoadjuvant therapy stage: PD-1 antibody 200mg, q3w, 3 weeks per cycle, 2-4 cycles
Platinum-based chemotherapy (squamous: carboplatin AUC5 d1, gemcitabine 1000mg/m2, d1, d8
non-squamous: carboplatin AUC5 d1, pemetrexed 500mg/m2, d1) , 3 weeks per cycle, 2-4 cycles, then receive chest CT evaluation. Surgical treatment.
Sponsors
Thoracic surgery of Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with NSCLC confirmed by needle biopsy or bronchoscopy biopsy; 2. Chest CT, PET-CT or / and EBUS were identified as stage III patients (TNM stage 8); 3. Patients without systemic metastasis (MRI, bone scan, PET-CT, liver and adrenal CT, etc.); 4. Patients over 18 years old; 5. Patients with at least one measurable tumor focus (the longest diameter measured by CT > 10 mm); 6. Patients with good function of other main organs (liver, kidney, blood system, etc.): – hemoglobin >= 90 g / L (can be maintained or exceeded by blood transfusion); – RBC count >= 2.0 x 10^12 / L – neutrophil absolute count (ANC) >= 1.0 x 10^9 / L; – platelet count >= 100 x 10^9 / L; – total bilirubin = 60ml / min; – the international standard ratio of prothrombin time (INR) < 1.5R and partial thromboplastin time (APTT) < 1.5 times the upper limit of normal value in patients who have not received anticoagulant treatment. Patients receiving full dose or parenteral anticoagulant therapy can enter the clinical trial as long as the dosage of anticoagulant is stable for at least 2 weeks before entering the clinical study, and the results of coagulation test are within the limits of local treatment. 7. Patients with ECoG PS score of 0-1; 8. Patients who are expected to undergo radical surgery; 9. Patients with good lung function and tolerance to surgical treatment; 10. Pregnant women of childbearing age must conduct pregnancy test within 7 days before treatment and the result is negative; reliable contraceptive measures (such as IUD, contraceptive pill and condom) should be used within 30 days before the start and end of the test; male subjects of childbearing age should use condom for contraception within 30 days after the start and end of the test; 11. Patients willing to sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have received any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment; 2. Patients with cancer other than NSCLC (excluding cervical carcinoma in situ, cured basal cell carcinoma, bladder epithelial tumor [including TA and tis]) within five years before the start of this study; 3. Patients with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases; 4. Patients with active hepatitis B, hepatitis C or HIV; 5. Patients who have had or are currently suffering from interstitial lung disease; 6. Patients who have undergone major surgery or severe trauma in other systems within 3 months before the start of this trial; 7. Patients who are allergic to the test drug or any auxiliary materials; 8. Patients suffering from nervous system diseases or mental diseases that cannot cooperate; 9. Patients with any malabsorption; 10. Pregnant or lactating women; 11. Other researchers think it is not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major pathologic response (MPR);Obeject response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year overall survival (2-y OS);disease-free survival (DFS);progression-free survival (PFS);overall survival (OS); | — |
Countries
China
Contacts
Public ContactPeng Zhang
Thoracic Surgery of Shanghai Pulmonary Hospital
Outcome results
None listed