Clinical trial NCT06718309: Chemotherapy Plus Immunotherapy Combined With SBRT as Neoadjuvant Therapy for Patients With Resectable NSCLC
Official title: A Prospective Cohort Study of Chemotherapy Plus Immunotherapy Combined With Stereotactic Body Radiotherapy as Neoadjuvant Therapy for Patients With Resectable Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: NSCLC
locally advanced
resectable
SBRT
immunotherapy
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pathological complete response (pCR)
timeFrame: Assessed up to 24 weeks
Secondary outcomes:
measure: Major pathologic response (MPR)
timeFrame: Assessed up to 24 weeks
measure: 1-year event-free survival (1 year EFS)
timeFrame: Assessed up to 100 months
measure: The R0 resection rate
timeFrame: Assessed up to 24 weeks
measure: Incidence of treatment-related adverse events
timeFrame: assessed up to 100 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Thoracic Oncology, Hangzhou Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Hangzhou Cancer Hospital
name: Lucheng Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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