Small Cell Lung Cancer
Conditions
Interventions
experimental group:Adebrelimab + Etoposide + Carboplatin/cisplatin
Neoadjuvant Therapy: Adebrelimab 1200mg, D1, every 3 weeks
Cisplatin 75mg/m2, or Carboplatin AUC = 5, every 3 weeks
Etoposide 100mg/m2, every 3 weeks
for 3 cycles.
Adjuvant Therapy: Adebrelimab 1200mg, D1, every 3 weeks
Cisplatin 75mg/m2 or Carboplatin AUC = 5
for 1 cycle.
(The specific administration timing of chemotherapeutic agents is subject to the operational requirements of the center.)
Consolidation Therapy Phase: Adebrelimab 1200mg, D1, every 3 week
Sponsors
Lung Cancer Center, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined this study, signed an informed consent form, and cooperated with follow-up; 2. Histologically/cytologically confirmed limited-stage small cell lung cancer (SCLC)??, including both resectable and potentially resectable cases.Resectable??: Patients with ??T1-2N0?? stage, suitable performance status for surgery, and willingness to undergo surgical intervention.Potentially resectable??: Refers to tumors invading critical structures (e.g., root of great vessels, trachea, or other unresectable vital organs), or cases with lymph node metastasis (N1, single-station or multi-station N2) that ??may become resectable after downstaging with chemotherapy combined with immunotherapy??.(according to the AJCC 8th edition); 3. Expected to achieve R0 resection; 4. CT or MRI scan with at least one measurable tumor lesion (meeting RECIST 1.1 criteria) = 1.5 × 10 ^ 9/L; 2) Hemoglobin (HB) >= 9g/dL; 3) Platelets (PLT) >= 100 × 10 ^ 9/L; 4) Serum albumin (ALB) >= 2.8g/dL. (2) Biochemical examination must comply with: 1) Total bilirubin (TBIL) = 50ml/min (Cockcroft Gault formula); 4) Thyroid function is normal. 11. Estimated survival time>=3 months; 12. The researchers determined that the patient can receive treatment with adelbilimumab combined with chemotherapy; 13. Female subjects with fertility should undergo a urine or serum pregnancy test within 72 hours before receiving the first study drug administration, and demonstrate a negative result. They are willing to use effective contraception methods from the trial period to 3 months after the last administration of adelbizumab; For male participants whose partners are women of childbearing age, effective methods of contraception should be used during the trial period and within 3 months after the last administration of adelbizumab; 14. The subjects have good compliance and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Known to be allergic to the investigational drug or any of its excipients; Or have experienced severe allergic reactions to other monoclonal antibodies; 2. Merge with other tumors; 3. Suffering from any active autoimmune disease or having a history of autoimmune diseases, such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (hormone replacement therapy can be included after normal treatment); 4. Suffering from cachexia; 5. Hypertension that cannot be well controlled through antihypertensive drug treatment (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg); 6. HBsAg positive and HBV DNA detection value exceeding the upper limit of normal value (1000 copy number/mL or 500 IU/mL), or HCV positive (HCV RNA or HCV Ab detection indicating acute or chronic infection), or known HIV positive medical history or known AIDS; 7. Subjects who are undergoing systemic treatment with corticosteroids ( >10mg/day, prednisone therapeutic dose) or other immunosuppressants within 14 days prior to the first use of the study drug; In the absence of active autoimmune diseases, it is allowed to inhale or locally use steroids and adrenal cortex hormone substitutes with a dose greater than 10mg/day and a therapeutic dose of prednisone; 8. Subjects who have experienced severe infections within 4 weeks prior to the first medication use, including but not limited to infection complications that require hospitalization, bacteremia, severe pneumonia, etc; Excluding subjects with any active infections; The possibility of lymph node spread in lung cancer cannot be ruled out; 9. Suffering from grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval >= 450 ms for males and >= 470 ms for females). According to NYHA standards, subjects with LVEF (Left Ventricular Ejection Fraction) < 50% were found to have grade III-IV heart failure or color Doppler ultrasound examination; 10. Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders; 11. According to the judgment of the researchers, the subjects may have other factors that may cause them to be forced to terminate the study midway, such as having other serious illnesses (including mental illness) that require concurrent treatment, severe abnormalities in laboratory test values, family or social factors, and difficulty in long-term follow-up; 12. The researcher determines other situations that are not suitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response;Objective response rate;Event-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactYan Zhang
Lung Cancer Center, West China Hospital, Sichuan University
Outcome results
None listed