Lung Cancer (SCLC)Phase 2NCT07258147

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

A Phase 2 study testing Immunotherapy, Chemotherapy (Etoposide, Nab-paclitaxel, Irinotecan, or Lurbinectedin) and low-dose radiation in people with Lung Cancer (SCLC), run by Sichuan University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Lung Cancer (SCLC)
What is being tested?: Immunotherapy, Chemotherapy (Etoposide, Nab-paclitaxel, Irinotecan, or Lurbinectedin) and low-dose radiation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteChina
Study dates: 31 Oct 2026to 30 Dec 2028
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Weigang Xiu, MD. Phd contact

+86 15982378768

xiuweigang1986@163.com

You Lu, MD. PhD contact

+86 189 8060 1763

radyoulu@hotmail.com

China1 site

West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Weigang Xiu, MD. PhD, +8615982378768, xiuweigang1986@163.com

Other trials in China

About this study

Official title: Clinical Study on the Efficacy and Safety of Radiotherapy Combined With Immunotherapy and Chemotherapy for Pre-treated Patients With Small Cell Lung Cancer and Liver Metastases

Read the detailed description

All eligible patients will receive liver-directed radiotherapy, followed by PD-1/PD-L1 inhibitors plus chemotherapy. The systemic therapy is initiated concurrently with radiotherapy. PD-1/PD-L1 inhibitors and chemotherapeutic agents (such as Etoposide, Nab-paclitaxel, Irinotecan, or Lurbinectedin) are administered intravenously every 3 weeks according to their approved product information. The treatment regimen consists of an initial concurrent phase of radiotherapy, immunotherapy, and chemotherapy, followed by a maintenance phase with PD-1/PD-L1 inhibitors alone until disease progression or for up to 24 months.Main Objective and Endpoint:

The primary objective is to evaluate the objective response rate (ORR) and safety of the combination therapy. The primary endpoint is the ORR, defined as the proportion of subjects achieving a complete response (CR) or partial response (PR) based on RECIST v1.1 criteria, as determined by the investigator.

Conditions: Lung Cancer (SCLC)
Being tested: Immunotherapy, Chemotherapy (Etoposide, Nab-paclitaxel, Irinotecan, or Lurbinectedin), low-dose radiation, Stereotactic Body Radiation Therapy (SBRT)
Keywords: SCLC, Radiotherapy, Immunotherapy, Chemotherapy
Medical subject headings: Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ImmunotherapyDrug
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
Chemotherapy (Etoposide, Nab-paclitaxel, Irinotecan, or Lurbinectedin)Drug
Combined With immunotherapy.
low-dose radiationRadiation
Liver-directed radiotherapy (low-dose radiation(3Gy*5d) followed by Immunotherapy
Stereotactic Body Radiation Therapy (SBRT)Radiation
low-dose radiation(3Gy*5d) +stereotactic body radiation therapy (10Gy*3d) )

Study groups in NCT07258147
Study group	Role	What they receive
Radiation therapy combined with immunotherapy and chemotherapy group	Experimental	Liver-directed radiotherapy (low-dose radiation(3Gy5d) or low-dose radiation(3Gy5d) +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. Receives: Drug: Immunotherapy; Drug: Chemotherapy (Etoposide, Nab-paclitaxel, Irinotecan, or Lurbinectedin); Radiation: low-dose radiation; Radiation: Stereotactic Body Radiation Therapy (SBRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
The time from the date of enrollment until the first documented date of disease progression as per RECIST v1.1, or death from any cause, whichever occurs first.
Measured: From enrollment until first progression or death, assessed up to approximately 3 years.
Disease Control Rate (DCR)
The proportion of participants who achieve a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST v1.1.
Measured: From enrollment until the first documented date of disease progression, assessed up to 24 months.
Incidence of Adverse Events (AEs)
The number and percentage of participants with any adverse event, serious adverse event, and immune-related adverse event. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Measured: From the first dose of study treatment until 30 days after the last dose (up to approximately 25 months).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Oct 202630 Dec 2028

First posted2 Dec 2025
Study start31 Oct 2026 (estimated)
Primary completion31 Dec 2027 (estimated)
Study completion30 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Lung Cancer (SCLC)Studies of the same condition, open and under way.
More trials run by Sichuan UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Single Group Assignment
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07258147
Sponsor's protocol ID: SCLC-LM-001
Status last verified: May 2026
First submitted: 18 Nov 2025
Last updated: 5 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 39490738
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.
PubMed 38964333

Study at a glance

From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study on the Efficacy and Safety of Radiotherapy Combined With Immunotherapy and Chemotherapy for Pre-treated Patients With Small Cell Lung Cancer and Liver Metastases
ClinicalTrials.gov ID: NCT07258147
Acronym / sponsor ID: SCLC-LM-001
Conditions: Lung Cancer (SCLC)
Keywords: SCLC, Radiotherapy, Immunotherapy, Chemotherapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 30 participants (estimated)
Lead sponsor: Sichuan UniversityUniversity, hospital or other
Study start: 31 Oct 2026 (estimated)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 30 Dec 2028 (estimated)
First posted: 2 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single Group Assignment

Arm	Type	Receives
Radiation therapy combined with immunotherapy and chemotherapy group	Experimental	Drug: Immunotherapy, Drug: Chemotherapy (Etoposide, Nab-paclitaxel, Irinotecan, or Lurbinectedin), Radiation: low-dose radiation, Radiation: Stereotactic Body Radiation Therapy (SBRT)Liver-directed radiotherapy (low-dose radiation(3Gy5d) or low-dose radiation(3Gy5d) +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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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.

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ImmunotherapyCombined With Chemotherapy( (Etoposide, Nab-paclitaxel, Irinotecan, or Lurbinectedin) ). Liver-directed radiotherapy (low-dose radiation(3Gy5d) or low-dose radiation(3Gy5d) +stereotactic body radiation therapy (10Gy*3d) ) followed by Immunotherapy	Drug	Radiation therapy combined with immunotherapy and chemotherapy group
Chemotherapy (Etoposide, Nab-paclitaxel, Irinotecan, or Lurbinectedin)Combined With immunotherapy.	Drug	Radiation therapy combined with immunotherapy and chemotherapy group
low-dose radiationLiver-directed radiotherapy (low-dose radiation(3Gy*5d) followed by Immunotherapy	Radiation	Radiation therapy combined with immunotherapy and chemotherapy group
Stereotactic Body Radiation Therapy (SBRT)low-dose radiation(3Gy5d) +stereotactic body radiation therapy (10Gy3d) )	Radiation	Radiation therapy combined with immunotherapy and chemotherapy group

Primary outcome

ORR
Time frame: 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.
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.

3 secondary outcomes

Progression-Free Survival (PFS)
Time frame: From enrollment until first progression or death, assessed up to approximately 3 years.
Disease Control Rate (DCR)
Time frame: From enrollment until the first documented date of disease progression, assessed up to 24 months.
Incidence of Adverse Events (AEs)
Time frame: From the first dose of study treatment until 30 days after the last dose (up to approximately 25 months).

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
Results publication: PubMed 39490738Chen 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.
Results publication: PubMed 38964333Wang 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Weigang Xiu, MD. Phd contact

+86 15982378768

xiuweigang1986@163.com

You Lu, MD. PhD contact

+86 189 8060 1763

radyoulu@hotmail.com

You Lu principal investigator

Principal Investigator

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Weigang Xiu, MD. Phd (+86 15982378768, xiuweigang1986@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07258147, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.