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Stereotactic body radiotherapy combined with paclitaxel/cisplatin and triplimumab in the treatment of stage IV driver gene-negative non-small cell lung cancer

Stereotactic body radiotherapy combined with paclitaxel/cisplatin and triplimumab in the treatment of stage IV driver gene-negative non-small cell lung cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064159
Enrollment
Unknown
Registered
2022-09-28
Start date
2022-09-25
Completion date
Unknown
Last updated
2023-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non small cell lung cancer

Interventions

Experimental group:standard treatment combined with SBRT
Conrol group:Immunotherapy combined with chemotherapy

Sponsors

Jinshan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years, male or female; 2. Stage IV NSCLC patients with negative driver genes confirmed by cytopathology or histopathology and imaging; 3. There must be at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RESIST version 1.1); 4. Physical status PS 0-1 or card score above 70; 5. Expected survival time >= 3 months; 6. Laboratory tests met the following criteria: (1) Bone marrow function: blood neutrophil (ANC) absolute count >= 1.5 x 10^9/L, platelet (PLT) >= 100 x 10^9/L, hemoglobin (HB) >= 90 g/L; (2) Liver function: serum total bilirubin (STB), conjugated bilirubin (CB) = 60 ml/min; (4) Thyroid function and cardiac function were normal; 7. Patients voluntarily signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with malignant pleural effusion or pericardial effusion; 2. combined with other tumors or a history of tumors in the past 3 years; 3. Patients with uncontrolled angina, myocardial infarction or heart failure; 4. Women who plan to become pregnant, are pregnant or lactating; 5. Long-term use of immunosuppressive agents after organ transplantation; Patients with severe autoimmune diseases who are using immunosuppressants; 6. The patient has a history of allergy to biological products such as interleukin-2, hypersensitivity reaction or other serious reactions; Known or suspected allergy to the study agent or any agent related to the trial; 7. Known history of human immunodeficiency virus (HIV), hepatitis C virus (HCV) or syphilis (TP) infection; 8. Patients with active infections.

Design outcomes

Primary

MeasureTime frame
Tumor size;

Countries

China

Contacts

Public ContactXibing Zhuang

Jinshan Hospital Affiliated to Fudan University

19111210024@fudan.edu.cn+86 18930815786

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026