Non-Small Cell Lung Cancer
Conditions
Keywords
NSCLC, locally advanced, resectable, SBRT, immunotherapy
Brief summary
In this study, patients with EGFR/ALK wild-type, resectable locally advanced NSCLC are expected to receive 1 cycle of chemoimmunotherapy as neoadjuvant therapy, followed by SBRT to the primary lung lesion, and chemoimmunotherapy for 2 cycles. Surgical treatment will be given within 4-6 weeks after the last cycle of chemoimmunotherapy, then immunotherapy maintenance for 1 year.
Interventions
DRUGChemotherapy
Patients with squamous cell carcinoma can choose paclitaxel + cisplatin/carboplatin and patients with nonsquamous cell carcinoma can choose pemetrexed + cisplatin/carboplatin. The chemotherapy treatment lasts 3 cycles.
DRUGImmunotherapy
Investigators choose PD-1 or PD-L1 according to drug indication and the immunotherapy lasts 3 cycles preoperatively and 1 year after surgery.
PROCEDURERadical resection of lung cancer
Radical resection of lung cancer with lymph node dissection
RADIATIONSBRT
SBRT for primary lung lesion 8Gy\*3F after first cycle of chemoimmunotherapy
Sponsors
First People's Hospital of Hangzhou
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
In this study, patients with surgically resectable locally advanced non-small cell lung cancer (stage II-IIIA and part of stage IIIB) (EGFR/ALK wild-type for adenocarcinoma patients) are enrolled. Eligible patients firstly receive one cycle of chemoimmunotherapy, followed by stereotactic body radiotherapy (SBRT) (8Gy\*3F) to the primary lung lesion and then continued with another two cycles of chemoimmunotherapy. Surgical treatment was performed within 4-6 weeks after the last chemoimmunotherapy. Immunotherapy continues until 1 year after surgery. Minimal residue lesion (MRD) are monitored at 5 timepoints during the treatment period.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically or pathologically confirmed, newly diagnosed non-small cell lung cancer patients; 2. Age ≥18 years; 3. (Eastern Cooperative Oncology Group, ECOG) (Performance Status, PS) score 0-1; 4. According to the 8th-9th edition of (American Joint Committee on Cancer, AJCC) (stage II-IIIA, for stage IIIB included T3-4N2, T4 only included tumor \> 7cm); 5. Puncture or biopsy samples were tested EGFR/ALK negative; 6. Surgically or potentially resectable after discussion by multidisciplinary team (MDT); 7. Who has not received systemic antitumor therapy and has not received chest radiotherapy; 8. Evaluable lesions in the lung or mediastinum; 9. The organ function level should meet the following criteria one week before enrollment: 1) Bone marrow function: hemoglobin ≥80g/L, white blood cell count ≥4.0\*10\^9/L or neutrophil count ≥1.5\*10\^9/L, platelet count ≥100\*10\^9/L; 2) Liver: total serum bilirubin level ≤1.5 times the normal upper limit, when serum total bilirubin level \> 1.5 times the normal upper limit, direct bilirubin level ≤ normal upper limit, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the normal upper limit; 3) Kidney: blood creatinine level \< 1.5 times the normal upper limit or creatinine clearance ≥50ml/min, urea nitrogen ≤200mg/L; Serum albumin ≥30g/L; 10. Male/female of childbearing age agrees to use contraception during the trial period (surgical ligation or oral contraceptives/IUDs + condom contraception); 11. Sign informed consent.
Exclusion criteria
1. Patients with severe dysfunctions of the heart, lungs and other organs who are not suitable for surgery; 2. Patients with severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granuloma), etc; 3. Other malignancies within 5 years (excluding non-melanoma skin cancer and cervical cancer); 4. Patient with active infection, heart failure, heart attack, unstable angina pectoris or unstable arrhythmia within the last 6 months; 5. Congenital or acquired immunodeficiency disorders include human immunodeficiency virus (HIV) or a history of organ transplantation or allogeneic stem cell transplantation; 6. Patients treated with other immunological agents, chemotherapy agents, other drugs in clinical trials and long-term cortisol therapy were excluded; 7. Patients who are allergic or contraindicated to PD-1 inhibitors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response (pCR) | Assessed up to 24 weeks | Pathological complete response for surgical patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major pathologic response (MPR) | Assessed up to 24 weeks | No more than 10% residual viable tumour in the resected tumour (up to 24 weeks) |
| 1-year event-free survival (1 year EFS) | Assessed up to 100 months | Interval between the start of neoadjuvant treatment and any progression of disease precluding surgical resection, progression of disease in the absence of surgery, progression or recurrence after surgery, or death from any cause, whichever occurred first |
| The R0 resection rate | Assessed up to 24 weeks | The proportion of patients who had complete surgical resection \[R0\] |
| Incidence of treatment-related adverse events | assessed up to 100 months | The incidence of adverse events ≥ grade 3 during perioperative period |
Countries
China
Contacts
Primary ContactYi Tang
Outcome results
None listed