A Randomized, Controlled, Multicenter Phase II Clinical Study Comparing Neoadjuvant Chemoimmunotherapy and Immuno-consolidationafter Compared With Immunoconsolidation After Radical Chemoradiotherapy for Stage III Potentially Resectable NSCLC

Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

To evaluate the efficacy and safety adebrelimab in Combination with chemotherapy after 3 cycles as neoadjuvant therapy and surgery or chemoradiotherapy based on MDT compared with adebrelimab after chemoradiotherapy in potentially operable stage III NSCLC.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 1\. Age 18-75 years old;

• 2\. Histologically or cytologically confirmed non-small cell lung cancer. If the pathological type of the patient is adenocarcinoma, genetic testing should be performed to exclude EGFR/ALK mutations. Tumor tissue should be the first choice for genetic testing. If sufficient tumor tissue is not available, genetic testing using serum can be performed.

• 3\. According to AJCC 8th Edition, the patient had stage IIIA-IIIB (T1-4N2M0). N2 was a non-giant type with lymph node diameter ≤3cm and no invasion or exocapsular invasion. Pathological biopsy of mediastinal lymph nodes is recommended to be clear, and patients without pathology should at least meet the short diameter of enhanced chest CT ≥1cm and high metabolism of PET-CT.

• 4\. All lesions (including primary lesions and lymph nodes/metastases evaluated as metastases) of the patient should be evaluated jointly by surgeons, radiologists, and radiologists to be potentially resectable.

• 5\. Subjects must have measurable target lesions (according to RECIST 1.1 criteria);

• 6\. ECOG behavior status score 0-1;

• 7\. No previous history of other malignant tumors;

• 8\. Never received anti-tumor therapy such as surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy related to non-small cell lung cancer;

• 9\. The patient should have adequate cardiopulmonary function: FEV1 and DLCO of the patient were ≥50% of the predicted value, and the ultrasonography suggested LVEF≥55%, and no clear signs of heart failure and severe coronary artery stenosis were found in various tests. The cardiopulmonary function was assessed by the surgeon as being able to tolerate surgical treatment.

• 10.The functional level of all vital organs must meet the following requirements:

‣ Bone marrow: absolute neutrophil count (ANC) ≥1.5× 109/L, platelet ≥100 × 109/L, hemoglobin ≥9 g /dl;

⁃ Good coagulation function: defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;

⁃ Liver: total bilirubin ≤1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5 times the upper limit of normal;

⁃ Kidney: serum creatinine ≤1.25 times the upper limit of normal or creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 ml/min;

• 11\. Fertile men and women of childbearing age must consent to effective contraceptive use from the time they sign the master informed consent until 180 days after the final administration of the study drug. Women of reproductive age include premenopausal women and women within 2 years after menopause. Pregnancy test results of women of reproductive age must be negative within ≤ 7 days before the first study drug administration;

• 12\. Voluntary participation in clinical research; Fully understand and know this study and sign ICF (Informed Consent).

Locations
Other Locations
China
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Contact Information
Primary
Jian Zeng, MD&PhD
hzzengjian123@163.com
+86 571 8812 8161
Backup
Taobo Luo, MD&PhD
luotaobo@163.com
+86 136 7587 0286
Time Frame
Start Date: 2024-05-19
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 92
Treatments
Experimental: neoadjuvant: adebrelimab combined with platinum-based chemotherapy
Adebrelimab 20mg/kg combined with platinum-based chemotherapy, q3w, MDT after 3 cycles, if the patient is suitable for surgery, surgery will be performed, and Adebrelimab adjuvant therapy will be performed for 35 cycles after surgery or until the disease recurrence or toxicity is difficult to tolerate as indicated by imaging; If the patient is not eligible for surgery after evaluation,, radical chemoradiotherapy will be performed, followed by Adebrelimab consolidation therapy for 35 cycles or until radiographically indicated disease recurrence or toxicity is difficult to tolerate.
Active_comparator: radical chemoradiotherapy and adebrelimab consolidation for 38 cycles
Consolidation therapy with adebrelimab , 20mg/kg, q3w, d1, was started within 1 to 42 days after radical chemoradiotherapy. The infusion time of adebrelimab was 60 minutes or more, and the treatment lasted for 38 consecutive cycles or until the disease recurred or the toxic reaction was difficult to tolerate as indicated by imaging.
Sponsors
Leads: Zeng Jian

This content was sourced from clinicaltrials.gov

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