Small cell lung cancer
Conditions
Interventions
Group one:EP regimen combined with HLX10 treatment.
Group two:Low-dose radiotherapy for metastatic lesions: 5 Gy per fraction, for a total of 1–2 fractions. After radiotherapy, continue treatment with the EP regimen combined with HLX10.
Group three:Spatial fractionated radiotherapy for the primary lesion: 15 Gy per fraction, for a total of 3 fractions. After radiotherapy, continue treatment with the EP regimen combined with HLX10.
Group four:The radiotherapy regimen will be determined by MDT (Multidisciplinary Team) discussion: For primary lesions < 5 cm: hypofractionated radiotherapy (5 Gy per fraction, 3–5 fractions in total)
Sponsors
General Hospital of Ningxia Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-75 years; ECOG performance status 0-1. (2) Histologically or cytologically confirmed small cell lung cancer (SCLC). (3) Extensive-stage disease, defined as lesions beyond one hemithorax, including malignant pleural or pericardial effusion or hematogenous metastasis (AJCC 8th edition stage IV [any T, any N, M1a/b/c]), or T3-4 due to multiple pulmonary nodules or excessively large tumor/nodule volume that cannot be included in a tolerable radiotherapy plan. (4) No prior history of other anti-tumor therapy, with an expected survival of at least 3 months. (5) No severe medical diseases or functional impairment of major organs, such as normal blood routine, liver, kidney, heart, and lung functions. (6) Female patients must meet one of the following criteria: a. Postmenopausal (defined as absence of menstruation for at least 1 year with no other confirmed causes except menopause); b. Surgically sterilized (ovariectomy and/or hysterectomy); c. Of childbearing potential, but must simultaneously satisfy: serum/urine pregnancy test within 7 days before randomization must be negative; agreement to use contraceptive methods with an annual failure rate < 1% or maintain abstinence (avoid heterosexual intercourse) (from signing the ICF until at least 6 months after the last dose of study drug). Contraceptive methods with an annual failure rate < 1% include bilateral tubal ligation, male sterilization, correct use of hormone contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, copper-containing intrauterine devices, or condoms; breastfeeding is prohibited. (7) Male patients must meet: agreement to abstain from heterosexual intercourse or use contraception as specified: if the partner is of childbearing age or pregnant, male patients must remain abstinent or use condoms during the study treatment and for at least 6 months after the last dose of study drug to prevent embryonic exposure to the drug. Periodic abstinence (e.g., calendar, ovulation, basal body temperature, or post-ovulation contraception) and withdrawal are unacceptable contraceptive methods. (8) Voluntary participation in the clinical study; full understanding and informed consent of the study, with signed ICF; willingness and ability to comply with and complete all trial procedures.
Exclusion criteria
Exclusion criteria: (1) Histologically or cytologically confirmed combined small cell lung cancer (SCLC). (2) Subjects eligible for surgical treatment. (3) Previous receipt of anti-tumor therapy for SCLC, including but not limited to radiotherapy, chemotherapy, and immunotherapy. (4) Having other active malignant tumors within 5 years or concurrently. Patients with cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, and carcinoma in situ of the breast are eligible for enrollment. (5) Patients preparing for or having previously received organ or bone marrow transplantation. (6) Pleural effusion, pericardial effusion, or ascites requiring clinical intervention. (7) Myocardial infarction occurring within 6 months before the first administration of the study drug, or poorly controlled arrhythmias (including QTc interval = 450 ms in males and = 470 ms in females) (QTc interval calculated using the Fridericia formula). (8) Heart failure of grade III-IV according to the NYHA criteria or left ventricular ejection fraction 1.5 mmol/L ionized calcium, or calcium > 12 mg/dL, or corrected serum calcium > upper limit of normal [ULN]). (10) Patients with = grade 2 CTCAE peripheral neuropathy. (11) Human immunodeficiency virus (HIV) infection with positive HIV antibody test results. (12) Active or latent pulmonary tuberculosis. (13) Subjects with a history or current presence of interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of pulmonary function, etc., which, in the investigator’s judgment, may interfere with the detection and management of suspected drug-related pulmonary toxicity. (14) Hepatitis B (positive HBsAg or HBcAb test results with positive HBV-DNA test results), hepatitis C (positive HCV antibody test results with positive HCV-RNA test results), or subjects with co-infection of hepatitis B and C (positive HBsAg or HBcAb test results with positive HCV antibody test results). (15) Subjects with known active or suspected autoimmune diseases. Subjects in a stable state who do not require systemic immunosuppressive therapy are allowed to enroll. (16) Receipt of live vaccine therapy within 28 days before the first administration of the study drug. However, inactivated viral vaccines for seasonal influenza are allowed, while intranasal administration of live attenuated influenza vaccines is not permitted. (17) Subjects requiring systemic corticosteroid therapy (> 10 mg/day prednisone equivalent) or other immunosuppressive drugs within 14 days before treatment or during the study period. The following situations are allowed for enrollment: in the absence of active autoimmune diseases, subjects are permitted to use topical or inhaled steroids and adrenal hormone replacement therapy at a dose = 10 mg/day prednisone equivalent. (18) Active infection requiring systemic anti-infective therapy within 14 days before treatment, or positive SARS-CoV-2 infection RT-PCR test results at the time of randomization. Subjects with a history of COVID-19 infection must have negative RT-PCR test results before the first administration of the study drug. (19) Receipt of major surgery within 28 days before treatment, where "major surgery" in this study is defined as surgery requiring a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progerssion Free Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, OS;Objective Response Rate,ORR;Time to Treatment Failure,TTF;Adverse Event;Serious Adverse Event; | — |
Countries
China
Contacts
Public ContactWang Yanyang
General Hospital of Ningxia Medical University
Outcome results
None listed