Adebrelimab + Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC

Last updated: June 24, 2025
Sponsor: Zhangzhou Municipal Hospital
Overall Status: Active - Not Recruiting

Phase

2

Condition

Non-small Cell Lung Cancer

Chemotherapy

Treatment

chemotherapy

Adebrelimab

Clinical Study ID

NCT07035392
2024KYZ432
  • Ages 18-70
  • All Genders

Study Summary

This study is a single arm, prospective, multicenter clinical trial, and eligible patients will receive the following treatment regimen: Adebrelimab combined with chemotherapy.The study includes a screening period (from the signing of informed consent by the subjects to no more than 28 days before the first medication, imaging examinations are allowed to be performed within 28 days before the first medication, and tumor tissue biopsy is allowed to be archived within 6 months before the first medication), a treatment period (including neoadjuvant and surgical treatment), and a follow-up period (including safety follow-up and survival follow-up).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 18 years old ≤ age ≤ 70 years old, male or female not limited;

  2. ECOG PS score 0-1 points;

  3. Patients who have not received systematic treatment in the past and agree to undergoradical surgery; Patients without surgical contraindications judged by thoracicsurgeons;

  4. Stage II, IIIA, or selective IIIB (T3N2M0 only) squamous or non squamous cellnon-small cell lung cancer confirmed by histopathology or cytology and judged byresearchers to be capable of undergoing R0 surgical resection for the purpose ofcure. Disease staging should be based on the American Joint Committee on Cancer (AJCC)/International Union Against Cancer (UICC) NSCLC staging system, 8th edition;

  5. There is sufficient tumor tissue to detect PD-L1 expression level and PD-L1 ≥ 1%;

  6. At least one measurable lesion (according to RECIST 1.1 criteria);

  7. The expected survival period is at least 12 weeks;

  8. Other major organs (liver, kidney, blood system, etc.) are functioning well:

  • Hemoglobin ≥ 90g/L (no blood transfusion, no use of hematopoietic factors, andno medication correction within 2 weeks before the first medication);

  • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L;

  • Platelet count ≥ 100 × 109/L; Total bilirubin ≤ 1.5 times the upper limit ofnormal value;

  • alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase ≤ 2.5 times the upper limit of normal values;

  • Serum creatinine ≤ 1.5 times the upper limit of normal value; And theendogenous creatinine clearance rate is ≥ 60ml/min; For patients who have notreceived anticoagulant therapy, the international normalized ratio (INR) ofprothrombin time is ≤ 1.5, and the activated partial thromboplastin time (APTT)is ≤ 1.5 times the upper limit of normal.

  1. Expected to be completely resected;

  2. Good lung function can tolerate surgical treatment;

  3. Female participants with fertility must undergo a pregnancy test (serum or urine)within 72 hours before starting the study medication, and the result must benegative. They must also be willing to use a medically recognized and effectivecontraceptive measure (such as intrauterine device, contraceptive pill, or condom)during the study period and within 90 days after the last administration of thestudy medication; For male participants whose partners are women of childbearingage, they must agree to use effective methods of contraception or have undergonesurgical sterilization during the study period and within 90 days after the laststudy administration;

  4. The subjects voluntarily joined this clinical study and signed an informed consentform.

Exclusion

Exclusion Criteria:

  1. Previously received any anti-tumor treatment, including radiotherapy, chemotherapy,immunotherapy, and traditional Chinese medicine anti-tumor treatment (excludingtreatment for malignant tumors that have been cured and have no recurrence ormetastasis for ≥ 5 years);

  2. Non squamous cell carcinoma histological types of NSCLC with EGFR mutation positiveor ALK positive subjects. Non squamous cell carcinoma subjects must undergo EGFRgene testing and ALK gene and/or immunohistochemical testing;

  3. Patients with distant metastases (including M1a, M1b, M1c);

  4. Suffering from any active autoimmune disease or history of autoimmune disease (suchas uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis,nephritis, hyperthyroidism, hypothyroidism (which can be included after hormonereplacement therapy), tuberculosis); Skin diseases that have completely relievedchildhood asthma and do not require any intervention or systemic treatment inadulthood (such as vitiligo, psoriasis, or hair loss) can be included, but patientswho require medical intervention with bronchodilators cannot be included;

  5. Exclude evidence of past or current pulmonary fibrosis, interstitial pneumonia,pneumoconiosis, radiological pneumonia, drug-induced pneumonia, imaging confirmedactive pneumonia, and severe impairment of lung function;

  6. Subjects who have received systemic therapy with corticosteroids (>10 mg/day ofprednisone or other equivalent hormones) or other immunosuppressive agents within 2weeks prior to their first administration. In the absence of active autoimmunediseases, inhalation or topical use of corticosteroids is allowed, as well asadrenal hormone replacement therapy with a dose of ≤ 10 mg/day effective dose ofprednisone;

  7. Imaging (CT or MRI) shows tumor invasion into large blood vessels or blurredboundaries with blood vessels; Or imaging (CT or MRI) shows the presence of anypulmonary cavities or necrotic lesions, as determined by the researcher;

  8. Individuals who have experienced arterial/venous thrombotic events within the first 6 months of enrollment, such as cerebrovascular accidents (including temporaryischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis,and pulmonary embolism;

  9. Within the first 3 months of enrollment, there have been significant clinicallysignificant bleeding symptoms or clear bleeding tendencies, such as gastrointestinalbleeding, hemorrhagic gastric ulcers, etc., or they are currently receivingthrombolytic or anticoagulant therapy;

  10. Prior to enrollment, there was a daily hemoptysis volume of 100mL or more or a highrisk of hemoptysis determined by the researcher;

  11. Individuals with hypertension who cannot achieve good control with antihypertensivemedication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90mmHg); Grade II or above myocardial ischemia or myocardial infarction, poorlycontrolled arrhythmia (including QTc interval ≥ 450ms for males and ≥ 470ms forfemales); According to NYHA standards, patients with grade III-IV cardiacdysfunction or those with left ventricular ejection fraction (LVEF)<50% as indicatedby cardiac ultrasound examination;

  12. Individuals who have undergone other major surgeries or severe injuries within thetwo months prior to the start of this experiment;

  13. Urine routine examination indicates urinary protein ≥ (++), or 24-hour urine proteinlevel ≥ 1g, or severe liver and kidney dysfunction;

  14. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeateddrainage;

  15. Allergic to the experimental drug;

  16. Merge with HIV infection or active viral hepatitis;

  17. Pregnant or lactating women; Subjects with fertility who are unwilling or unable totake effective contraceptive measures;

  18. Individuals with neurological disorders or mental illnesses who are unable tocooperate;

  19. Cervical carcinoma in situ, basal cell or squamous cell carcinoma that can beadequately treated, local prostate cancer after radical surgery, and ductalcarcinoma in situ after radical surgery are excluded from concurrent malignanttumors occurring ≤ 5 years before enrollment;

  20. Researchers believe that there are other situations that are not suitable forinclusion.

Study Design

Total Participants: 32
Treatment Group(s): 2
Primary Treatment: chemotherapy
Phase: 2
Study Start date:
June 20, 2025
Estimated Completion Date:
December 01, 2026