Chemotherapy Plus Immunotherapy Combined With SBRT as Neoadjuvant Therapy for Patients With Resectable NSCLC

Zhejiang University

Status and phase

Enrolling

Phase 2

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: Immunotherapy

Procedure: Radical resection of lung cancer

Radiation: SBRT

Drug: Chemotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06718309

HZCH-2024-003

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically or pathologically confirmed, newly diagnosed non-small cell lung cancer patients;
Age ≥18 years;
(Eastern Cooperative Oncology Group, ECOG) (Performance Status, PS) score 0-1;
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);
Puncture or biopsy samples were tested EGFR/ALK negative;
Surgically or potentially resectable after discussion by multidisciplinary team (MDT);
Who has not received systemic antitumor therapy and has not received chest radiotherapy;
Evaluable lesions in the lung or mediastinum;
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;
Male/female of childbearing age agrees to use contraception during the trial period (surgical ligation or oral contraceptives/IUDs + condom contraception);
Sign informed consent.

Exclusion criteria

Patients with severe dysfunctions of the heart, lungs and other organs who are not suitable for surgery;
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;
Other malignancies within 5 years (excluding non-melanoma skin cancer and cervical cancer);
Patient with active infection, heart failure, heart attack, unstable angina pectoris or unstable arrhythmia within the last 6 months;
Congenital or acquired immunodeficiency disorders include human immunodeficiency virus (HIV) or a history of organ transplantation or allogeneic stem cell transplantation;
Patients treated with other immunological agents, chemotherapy agents, other drugs in clinical trials and long-term cortisol therapy were excluded;
Patients who are allergic or contraindicated to PD-1 inhibitors.