Triple threat: Low-Dose radiation plus chemo and immunotherapy takes on tough lung cancer
NCT ID NCT05765825
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing a new approach for people with extensive-stage small cell lung cancer who have not had prior treatment. It combines low-dose radiation with standard chemotherapy (cisplatin or carboplatin plus etoposide) and the immunotherapy drug serplulimab. The goal is to see if this combination can delay cancer progression and improve survival. The study enrolled 61 participants across multiple centers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- serplulimab (an immunotherapy drug), cisplatin or carboplatin (chemotherapy), etoposide (chemotherapy), and low-dose radiotherapy
- What this could lead to
- If this works, it could point toward a more effective first-line treatment for extensive-stage small cell lung cancer, potentially improving how long people live without their cancer getting worse.
- What could go wrong
- This is a small, early-phase (phase 2) study with no comparison group, so results are uncertain. The combination of treatments may cause significant side effects, and it is not yet known if it will be better than standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 61 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515041, China
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China West Hospital
Chengdu, Sichuan, 610000, China
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Chongqing University cancer hospital
Chongqing, Chongqing Municipality, 400030, China
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
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GuiZhou Provincial People's Hospital
Guiyang, China
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LiaoNing Cancer Hospital & Institute
Shenyang, Liaoning, 110801, China
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Shandong Provincial Hospital
Jinan, Shandong, 250021, China
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
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Other studies related to the condition(s) this trial covers.
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- Can a Two-Drug attack shrink tough lung cancers?
- Can a smartphone app ease the burden of advanced lung cancer?
- Cholesterol-Lowering drug may boost lung cancer immunotherapy
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