Low-dose radiotherapy with chemotherapy and serplulimab for extensive-stage small-cell lung cancer

Phase II, Single-Arm Study of Low-Dose Radiotherapy (LDRT) Concurrent Cisplatin/Carboplatin Plus Etoposide With Serplulimab for Patients With Extensive-Stage Small Cell Lung Cancer

This study is testing a new treatment combining low-dose radiation, chemotherapy, and serplulimab to see if it helps people with extensive-stage small-cell lung cancer who haven't had treatment before.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sichuan University (Academic / other)
• Drugs / interventions: radiation, serplulimab, chemotherapy
• Locations: 8 sites (Chongqing, Chongqing and 7 other locations)
• Trial ID: NCT05765825 on ClinicalTrials.gov

What this trial studies

This Phase II, single-arm, multicenter study evaluates the safety and efficacy of low-dose radiotherapy combined with cisplatin/carboplatin and etoposide, alongside serplulimab, in patients with extensive-stage small-cell lung cancer who have not received prior treatment. Participants will undergo an induction period consisting of four cycles of treatment, with efficacy assessments conducted at specified intervals. The study aims to determine the effectiveness of this combination therapy in shrinking tumors and improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are patients with histologically or cytologically confirmed extensive-stage small-cell lung cancer who have not received prior treatment.

Not a fit: Patients with prior treatment for extensive-stage small-cell lung cancer or those with poor performance status may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could improve survival rates and quality of life for patients with extensive-stage small-cell lung cancer.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in combining radiotherapy with immunotherapy and chemotherapy in other cancer types.

Eligibility criteria

Main Inclusion Criteria:

1. Histologically or cytologically confirmed ES-SCLC
2. No prior treatment for ES-SCLC
3. Measurable disease, as defined by RECIST v1.1. Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation.
4. ECOG performance status of 0 or 1
5. Life expectancy \>= 3 months
6. Adequate hematologic and end-organ function
7. For participants receiving therapeutic anticoagulation: stable anticoagulant regimen
8. Negative human immunodeficiency virus (HIV) test at screening
9. Negative hepatitis B surface antigen (HBsAg) test at screening
10. Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: Negative total hepatitis B core antibody (HBcAb), or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test. The HBV DNA test will be performed only for participants who have a negative HBsAg test, a negative HBsAb test, and a positive total HBcAb test.
11. Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for participants who have a positive HCV antibody test.
12. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception
13. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

Main Exclusion Criteria:

1. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
2. Participants with pulmonary artery invasion
3. History of leptomeningeal disease
4. Uncontrolled tumor-related pain
5. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
6. Uncontrolled or symptomatic hypercalcemia
7. Active or history of autoimmune disease or immune deficiency
8. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
9. Active tuberculosis
10. Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
11. History of malignancy other than small cell lung cancer (SCLC) within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death

Where this trial is running

Chongqing, Chongqing and 7 other locations

• Chongqing University cancer hospital — Chongqing, Chongqing, China (Recruiting)
• Cancer Hospital of Shantou University Medical College — Shantou, Guangdong, China (Recruiting)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• LiaoNing Cancer Hospital & Institute — Shenyang, Liaoning, China (Recruiting)
• Shandong Provincial Hospital — Jinan, Shandong, China (Recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai, China (Recruiting)
• China West Hospital — Chengdu, Sichuan, China (Recruiting)
• GuiZhou Provincial People's Hospital — Guiyang, China (Recruiting)

Study contacts

• Study coordinator: Zhuoran Yao, MD

Conditions Extensive-stage Small-cell Lung Cancer