Safety and Efficacy of Radiotherapy Combined With Immunochemotherapy in Pre-treated SCLC Patients With Liver Metastases

NCT07258147 | Not Yet Recruiting Phase 2

• 1 other identifier: SCLC-LM-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is clinical trial evaluating the safety and efficacy of radiotherapy combined with immunotherapy and chemotherapy in patients with extensive-stage small-cell lung cancer (ES-SCLC) and liver metastases.

Conditions

Lung Cancer (SCLC)

Keywords

SCLC; Radiotherapy; Immunotherapy; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• ORR

  The proportion of participants who achieve a best overall response of Complete Response (CR) or Partial Response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by the investigator.

  From date of enrollment until the first documented date of disease progression or death from any cause (whichever occurs first), assessed up to 24 months.

Secondary Outcomes (3)

• Progression-Free Survival (PFS)

  From enrollment until first progression or death, assessed up to approximately 3 years.

• Disease Control Rate (DCR)

  From enrollment until the first documented date of disease progression, assessed up to 24 months.

• Incidence of Adverse Events (AEs)

  From the first dose of study treatment until 30 days after the last dose (up to approximately 25 months).

Study Arms (1)

Radiation therapy combined with immunotherapy and chemotherapy group

EXPERIMENTAL

Liver-directed radiotherapy (low-dose radiation(3Gy\*5d) or low-dose radiation(3Gy\*5d) +stereotactic body radiation therapy (10Gy\*3d) ) followed by immunotherapy combined with chemotherapy (Etoposide, Nab-paclitaxel, Irinotecan, or Lurbinectedin) administered systemically every 3 weeks. Immunotherapy is continued as maintenance therapy until disease progression or for up to 24 months.

Drug: Immunotherapy; Drug: Chemotherapy (Etoposide, Nab-paclitaxel, Irinotecan, or Lurbinectedin); Radiation: low-dose radiation; Radiation: Stereotactic Body Radiation Therapy (SBRT)

Interventions

low-dose radiation RADIATION

Liver-directed radiotherapy (low-dose radiation(3Gy\*5d) followed by Immunotherapy

Radiation therapy combined with immunotherapy and chemotherapy group

Stereotactic Body Radiation Therapy (SBRT) RADIATION

low-dose radiation(3Gy\*5d) +stereotactic body radiation therapy (10Gy\*3d) )

Radiation therapy combined with immunotherapy and chemotherapy group

Immunotherapy DRUG

Combined With Chemotherapy( (Etoposide, Nab-paclitaxel, Irinotecan, or Lurbinectedin) ). Liver-directed radiotherapy (low-dose radiation(3Gy\*5d) or low-dose radiation(3Gy\*5d) +stereotactic body radiation therapy (10Gy\*3d) ) followed by Immunotherapy

Radiation therapy combined with immunotherapy and chemotherapy group

Chemotherapy (Etoposide, Nab-paclitaxel, Irinotecan, or Lurbinectedin) DRUG

Combined With immunotherapy.

Radiation therapy combined with immunotherapy and chemotherapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 75 years, with an ECOG Performance Status of 0-2.
• Histologically confirmed stage IV non-small cell lung cancer (NSCLC) or extensive-stage small cell lung cancer, with radiologically confirmed liver metastases (at least one measurable lesion with the longest diameter ≥ 1 cm).
• Prior failure (due to progression or intolerance) to platinum-based doublet chemotherapy and PD-1/PD-L1 inhibitor therapy.
• Adequate liver function reserve (Child-Pugh class A or B, ALT/AST ≤ 5 × ULN, total bilirubin ≤ 1.5 × ULN).
• Life expectancy of at least 3 months.
• Normal function of major organs and no severe dysfunction of the hematopoietic, cardiac, pulmonary, hepatic, renal, or bone marrow systems, or immunodeficiency diseases.
• Within one week prior to enrollment, bone marrow and organ function meet the following criteria:Hemoglobin ≥ 80 g/L, neutrophil count ≥ 1.5 × 10⁹/L, and platelet count ≥ 70 × 10⁹/L. Renal function: Serum creatinine ≤ 1.5 × ULN, and endogenous creatinine clearance rate ≥ 55 ml/min.Liver function: Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN (if liver metastases are present, total bilirubin ≤ 3 × ULN and transaminases ≤ 5 × ULN are acceptable).
• Voluntarily participates and provides written informed consent.
• Good compliance and willingness to adhere to the study visit schedule and other protocol requirements.
• Willingness to provide blood and tissue samples for biomarker testing.
• Judged by the radiation oncologist to have no contraindications to liver radiotherapy. Patients who agree to receive immunotherapy, chemotherapy, and radiotherapy.
• For patients of childbearing potential: agreement to use effective contraception during the study period and for at least 6 months after the last study treatment; negative serum or urine pregnancy test within 7 days prior to study entry; and not breastfeeding. Male patients with partners of childbearing potential must agree to use effective contraception during the study and for 6 months after the last dose.

You may not qualify if:

• Presence of any active autoimmune disease or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism \[may be included if controlled with hormone replacement therapy\]); prior liver radiotherapy or liver transplantation; history of liver cirrhosis (Fibroscan ≥ F3), portal hypertension, or hepatic encephalopathy.
• Congenital or acquired immunodeficiency, such as Human Immunodeficiency Virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (positive HCV antibody and HCV RNA above the lower limit of detection of the assay), or co-infection with both hepatitis B and C.
• Uncontrolled or significant cardiac disease, including: (a) NYHA Class II or higher heart failure; (b) Unstable angina; (c) Myocardial infarction within the past 1 year; (d) Patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.
• Severe infection or serious comorbidities within 4 weeks prior to the first dose of study treatment.
• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• History of other primary malignancies within the past 5 years.
• Known allergy to any of the trial drugs or their excipients.
• Pregnant or lactating women, or subjects of childbearing potential unwilling to use effective contraception during the study period.
• Patients with Child-Pugh class B or C liver insufficiency.
• Any other contraindication as determined by the investigator to preclude participation in the study.

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (2)

• Chen Z, Wu L, Wang Q, Yu Y, Liu X, Ma R, Li T, Li Y, Song X, Li L, Zhao W, Wang Q, Xu X, Lu S. Brief Report: Ivonescimab Combined With Etoposide Plus Carboplatin as First-Line Treatment for Extensive-Stage SCLC: Results of a Phase 1b Clinical Trial. J Thorac Oncol. 2025 Feb;20(2):233-239. doi: 10.1016/j.jtho.2024.10.013. Epub 2024 Oct 28.

  PMID: 39490738 RESULT

• Wang H, Yao Z, Kang K, Zhou L, Xiu W, Sun J, Xie C, Yu M, Li Y, Zhang Y, Zheng Y, Lin G, Pan X, Wu Y, Luo R, Wang L, Tang M, Liao S, Zhu J, Zhou X, Zhang X, Xu Y, Liu Y, Peng F, Wang J, Xiang L, Yin L, Deng L, Huang M, Gong Y, Zou B, Wang H, Wu L, Yuan Z, Bi N, Fan M, Xu Y, Tong R, Yi L, Gan L, Xue J, Mo X, Chen C, Na F, Lu Y. Preclinical study and phase II trial of adapting low-dose radiotherapy to immunotherapy in small cell lung cancer. Med. 2024 Oct 11;5(10):1237-1254.e9. doi: 10.1016/j.medj.2024.06.002. Epub 2024 Jul 3.

  PMID: 38964333 RESULT

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Immunotherapy; Drug Therapy; Etoposide; 130-nm albumin-bound paclitaxel; Irinotecan; PM 01183; Radiation; Radiosurgery

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Camptothecin; Alkaloids; Heterocyclic Compounds; Physical Phenomena; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• You Lu

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weigang Xiu, MD. Phd

CONTACT

+86 15982378768; xiuweigang1986@163.com

You Lu, MD. PhD

CONTACT

+86 189 8060 1763; radyoulu@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Division of Thoracic Tumor Multimodality Treatment

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 2, 2025
• Study Start (Estimated): October 31, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)