Adebrelimab Combined with Chemotherapy and Thoracic Radiotherapy for First-line Treatment of ES-SCLC

Inclusion Criteria:

1. Aged 18-75 years, male or female;

2. Histologically or cytologically confirmed extensive stage small cell lung cancer (according to the Veterans Lung Administration Lung Study Group, VALG stage);

3. ECOG performance status score 0 ~ 1;

4. No prior line of systemic therapy for ES-SCLC;

5. Liver metastases ≤ 3 at diagnosis;

6. Patients without previous brain metastases or treated asymptomatic CNS metastases,

7. Expected survival ≥ 12 weeks;

8. At least one measurable target lesion (according to RECISTv1.1 criteria) on imagingassessment (CT or MRI) within 4 weeks prior to enrollment;

9. The function of vital organs meets the requirements;

10. Female subjects of childbearing potential must have a negative serum pregnancy testwithin 7 days prior to the first dose and must agree to use effective contraceptionduring the trial and 2 months after the last dose of adalimumab or 6 months afterthe chemotherapy agent, whichever is longer;

11. Patients voluntarily join this study, sign informed consent, have good compliance,and cooperate with follow-up.

Exclusion Criteria:

1. Histologically or cytologically determined as a mixed pathological type withcomponents such as non-small cell lung cancer;

2. Active or untreated CNS metastases detected by computed tomography (CT) or magneticresonance imaging (MRI) during the screening period and previous imagingassessments;

3. Spinal cord compression that is not relieved by surgery and/or radiotherapy;

4. Clinically symptomatic third space effusion requiring repeated drainage within 2weeks, such as pericardial effusion, pleural effusion, and abdominal effusion thatare still uncontrollable by pumping or other treatments;

5. Complicated with other malignant tumors ≤ 5 years before the first dose, except foradequately treated cervical carcinoma in situ, basal cell or squamous cell skincancer, local prostate cancer after radical resection, and ductal carcinoma in situafter radical resection (hormone therapy for non-metastatic prostate cancer orbreast cancer is allowed);

6. Patients with active, known, or suspected autoimmune disease. Patients with type 1diabetes treated with stable doses of insulin, hypothyroidism requiring hormonereplacement therapy only, and skin diseases (e.g., eczema, vitiligo, or psoriasis)not requiring systemic therapy and not exacerbated within the year before thescreening period were excluded;

7. Patients diagnosed with immunodeficiency or receiving systemic glucocorticoidtherapy or any other form of immunosuppressive therapy not directly related to tumortherapy within 7 days before the first dose of study drug; physiological doses ofglucocorticoids (prednisone ≤ 10 mg/day or equivalent) are allowed;

8. HBsAg positive and HBV DNA copy number greater than the upper limit of normal (1000copies/ml or 500 IU/ml), or HCV positive (HCV RNA or HCV Ab detection suggests acuteand chronic infection); known HIV positive history or known acquiredimmunodeficiency syndrome (AIDS);

9. A history of idiopathic pulmonary fibrosis, interstitial pneumonia, tissue pneumonia (such as occlusive vasculitis), drug-induced pneumonia, radiation pneumonitisrequiring steroid therapy or clinically symptomatic active pneumonia; or othersevere lung disease that seriously affects lung function;

10. Patients with active pulmonary tuberculosis (TB) or history of active pulmonarytuberculosis infection ≤ 48 weeks before screening, regardless of treatment;

11. Presence of severe infection at randomization, including but not limited toinfectious complications requiring hospitalization, bacteremia, severe pneumonia,etc.;

12. Major surgery within 28 days prior to randomization, or planned major surgery duringthe study period;

13. Use of live attenuated vaccines within 28 days prior to randomization, oranticipated need for live attenuated vaccines during the study;

14. Cardiac function and disease which is considered clinically significant by theinvestigator;

15. Patients who have previously received allogeneic bone marrow transplantation orsolid organ transplantation;

16. Known hypersensitivity to the study drug or excipients, known serious allergicreactions to any monoclonal antibody; history of allergy to carboplatin/cisplatin oretoposide;

17. Received any other investigational drug or participated in another interventionalclinical study within 4 weeks before signing the ICF;

18. Known mental illness, alcoholism, inability to quit smoking, drug abuse or drugabuse;

19. Pregnant or lactating women; as judged by the investigator, the patient has otherfactors that may cause forced halfway termination of this study, such asnon-compliance with the protocol, other serious diseases (including mental illness)requiring concomitant treatment, severe laboratory abnormalities, accompanied byfamily or social factors, which may affect the safety of patients, or the collectionof data and samples.