Extensive Stage Small Cell Lung Cancer (ES-SCLC)Phase 2NCT07425795
Tislelizumab Combined With Chemotherapy Followed by Thoracic Consolidation Radiotherapy in the First-line Treatment of Extensive Stage Small Cell Lung Cancer
A Phase 2 study testing Tislelizumab Combined With Chemotherapy in people with Extensive Stage Small Cell Lung Cancer (ES-SCLC), run by Chongqing University Cancer Hospital at 1 site in China.
Trial summary
This study is a prospective, single arm, phase II clinical trial. We plan to include 36 newly diagnosed ES-SCLC patients who meet the inclusion criteria and receive induction therapy (tislelizumab+EP regimen, 4-6 cycles). After completing the induction therapy, efficacy evaluation will be conducted. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extensive Stage Small Cell Lung Cancer (ES-SCLC)
- What is being tested?
- Tislelizumab Combined With Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2025to 31 Jul 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
- Signed informed consent;
- Age 18-75 years;
- According to the judgment of the investigator, the patient was able to comply with the study protocol;
- Histologically or cytologically confirmed extensive stage small cell lung cancer (es-sclc) (according to the Veterans Administration lung cancer association [valg] staging system);
- No previous systemic treatment for ES-SCLC;
- With measurable lesions assessed by the investigator according to RECIST version 1.1;
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- ECOG physical status score was 0 or 1;
- Life expectancy ≥ 3 months;
- Adequate hematology and end organ function, as defined by the following laboratory findings, which should be obtained within 14 days before the first study treatment: absolute neutrophil count (ANC) ≥ 1.5 × 10^9/l (without granulocyte colony-stimulating factor treatment); Lymphocyte count ≥ 0.5 × 10^9/l (500 / μ L); Platelet count ≥ 100 × 10^9/l (100000 / μ L); Hemoglobin ≥ 90g/l (9.0g/dl); Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) ≤ 2.5 × upper limit of normal (ULN), with the following exceptions: Patients with confirmed liver metastasis: AST and alt ≤ 5 × ULN; Patients with confirmed liver or bone metastasis: ALP ≤ 5 × ULN; Total bilirubin ≤ 1.5 × ULN, with the following exceptions: patients known to have Gilbert syndrome: total bilirubin ≤ 3 × ULN; Creatinine clearance ≥ 60ml/min (calculated by Cockcroft Gault formula); Albumin ≥ 25g/l (2.5g/dl).
Who cannot join
- Symptomatic, untreated, or actively progressive central nervous system (CNS) metastases; ·Patients with CNS lesions who were treated and asymptomatic were eligible for this study if they met all of the following criteria: measurable lesions that met the recistv1.1 definition were outside the CNS; The patient had no history of intracranial hemorrhage or spinal cord hemorrhage; Patients did not receive stereotactic radiotherapy within 7 days before the start of study treatment, whole brain radiotherapy within 14 days before the start of study treatment, or neurosurgical resection within 28 days before the start of study treatment; Patients do not need to continue to receive corticosteroids for CNS disease. Treatment with stable doses of anticonvulsants was allowed. Metastasis was limited to the cerebellum or supratentorial region (i.e., not to the midbrain, pons, medulla oblongata, or spinal cord); There was no evidence of progression between the completion of CNS local therapy and the initiation of study therapy asymptomatic patients with CNS metastases who could be enrolled according to the assessment of other investigators could be enrolled;
- History of leptomeningeal disease;
- Poorly controlled pleural effusion, pericardial effusion or ascites requiring repeated drainage (once a month or more frequently);
- Poorly controlled or symptomatic hypercalcemia (ionized calcium >1.5mmol/l, calcium >12mg/dl or corrected calcium >uln);
- Have active or ever suffered from autoimmune disease or immunodeficiency;
- Have a history of idiopathic pulmonary fibrosis, organized pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia or idiopathic pneumonia;
- Active pulmonary tuberculosis;
- Untreated chronic hepatitis B patients, chronic hepatitis B virus carriers with HBV DNA ≥ 500 iu/ml (2500 copies /ml), active hepatitis C patients: inactive HBsAg carriers, patients with stable active HBV infection after drug treatment (HBV dna<500 iu/ml (2500 copies /ml)) can be enrolled. HBV DNA testing was only performed in patients who tested positive for hepatitis B core antibody (anti HBC antibody). Patients with negative hepatitis C virus (HCV) antibody test at screening, or patients with positive HCV antibody and negative HCV RNA test at screening can be enrolled in the study. HCV RNA testing will only be performed in patients with positive hepatitis C virus (HCV) antibody. Note: Patients with detectable hepatitis B surface antigen (HBsAg) or detectable HBV DNA should be treated according to treatment guidelines. Patients treated with antiviral drugs at the time of screening should have been treated for >2 weeks before enrollment and continue to be treated for 6 months after termination of study drug treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chongqing University Affiliated Cancer Hospital
Chongqing, Chongqing Municipality, 400000
Wei Zhou, Professor, 86-13883465672, 1052308491@qq.com
About this study
Official title: A Prospective, Single Arm, Phase II Clinical Study of Tislelizumab Combined With Chemotherapy Followed by Thoracic Consolidation Radiotherapy in the First-line Treatment of Extensive Stage Small Cell Lung Cancer
This study is a prospective, single arm, phase II clinical trial. We plan to include 36 newly diagnosed ES-SCLC patients who meet the inclusion criteria and receive induction therapy (tislelizumab+EP regimen, 4-6 cycles). After completing the induction therapy, efficacy evaluation will be conducted. Patients with remission will receive tislelizumab combined with consolidation chest radiotherapy (TRT) sequentially. After the consolidation therapy is completed, they will receive tislelizumab maintenance therapy until disease progression, intolerable toxicity, or withdrawal of informed consent occurs, whichever occurs first. The treatment duration will not exceed 2 years.
- Being tested
- Tislelizumab Combined With Chemotherapy
- Keywords
- Extensive stage small cell lung cancer, tislelizumab, thoracic consolidation radiotherapy, first-line treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab Combined With ChemotherapyDrug
Also called thoracic consolidation radiotherapy
Patients with newly diagnosed ES-SCLC receive induction therapy (tislelizumab+EP regimen, 4-6 cycles). After completing the induction therapy, efficacy evaluation is conducted. Those who experience remission are sequentially treated with tislelizumab combined with consolidation chest radiotherapy (TRT). After the consolidation therapy is completed, tislelizumab maintenance therapy is received until disease progression, intolerable toxicity, or withdrawal of informed consent occurs, whichever occurs first. The maximum duration of treatment is 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Tislelizumab Combined With Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Progression free survival (PFS): defined as the period from enrollment to the date of the first recorded tumor progression (assessed according to RECIST v1.1 criteria, regardless of whether treatment is continued or not) or the date of death from any cause, whichever occurs first, assessed up to 24 months.
Measured: From enrollment to the date of the first recorded tumor progression (assessed according to RECIST v1.1 criteria, regardless of whether treatment is continued or not) or the date of death from any cause, whichever occurs first, assessed up to 24 months.
Secondary outcomes (4)
Objective response rate
Defined as the proportion of patients with BOR rated as CR or PR according to RECIST v1.1 criteria from the start of enrollment. If the therapeutic effect reaches CR or PR, the patient must confirm it no less than 4 weeks (28 days) after the initial evaluation, assessed up to 6 weeks (42 days) . The best overall efficacy refers to the best efficacy evaluated by the researcher, which is the best efficacy recorded during the period from the patient's enrollment to the date of objective recording of disease progression according to RECIST v1.1 standards or the date of starting subsequent anti-tumor treatment (whichever occurs first). For patients who have not recorded disease progression or started subsequent anti-tumor treatment, the optimal overall efficacy will be determined based on all efficacy evaluation results.
Measured: The proportion of patients with BOR rated as CR or PR according to RECIST v1.1 criteria from the start of enrollment to progressive disease, assessed up to 24 months.
Disease control rate
Defined as the proportion of patients who, from enrollment, have the best overall response (BOR) evaluated according to RECIST v1.1 criteria as complete response (CR), partial response (PR), and disease stability (SD).
Measured: The proportion of patients who, from enrollment to progressive disease, assessed up to 24 months
Duration of remission
Defined as the time from the first recorded objective remission to recurrence or death for any reason, as determined by the researcher based on RECIST v1.1, whichever occurs first.
Measured: From enrollment to the first recorded objective remission to recurrence or death for any reason, as determined by the researcher based on RECIST v1.1, whichever occurs first, assessed up to 24 months.
Overall survival
Defined as the time between enrollment and death from any cause.
Measured: The time between enrollment and death from any cause, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start10 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extensive Stage Small Cell Lung Cancer (ES-SCLC)Studies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing University Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Zhou, Chongqing University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425795
- Sponsor's protocol ID
- CZLS2025121-A
- Status last verified
- Feb 2026
- First submitted
- 8 Sep 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen D, Zou B, Li B, Gao A, Huang W, Shao Q, Meng X, Zhang P, Tang X, Hu X, Zhang Y, Guo J, Zhao C, Yuan J, Li Q, Zhu C, Yu J, Wang L. Adebrelimab plus chemotherapy and sequential thoracic radiotherapy as first-line therapy for extensive-stage small-cell lung cancer (ES-SCLC): a phase II trial. EClinicalMedicine. 2024 Aug 21;75:102795. doi: 10.1016/j.eclinm.2024.102795. eCollection 2024 Sep.
PubMed 39252865
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Arm, Phase II Clinical Study of Tislelizumab Combined With Chemotherapy Followed by Thoracic Consolidation Radiotherapy in the First-line Treatment of Extensive Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07425795
- Acronym / sponsor ID
- CZLS2025121-A
- Keywords
- Extensive stage small cell lung cancer, tislelizumab, thoracic consolidation radiotherapy, first-line treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Chongqing University Cancer HospitalUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 23 Feb 2026 (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.
This study is a prospective, single arm, phase II clinical trial. We plan to include 36 newly diagnosed ES-SCLC patients who meet the inclusion criteria and receive induction therapy (tislelizumab+EP regimen, 4-6 cycles). After completing the induction therapy, efficacy evaluation will be conducted. Patients with remission will receive tislelizumab combined with consolidation chest radiotherapy (TRT) sequentially. After the consolidation therapy is completed, they will receive tislelizumab maintenance therapy until disease progression, intolerable toxicity, or withdrawal of informed consent occurs, whichever occurs first. The treatment duration will not exceed 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Tislelizumab Combined With Chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed informed consent;
- Age 18-75 years;
- According to the judgment of the investigator, the patient was able to comply with the study protocol;
- Histologically or cytologically confirmed extensive stage small cell lung cancer (es-sclc) (according to the Veterans Administration lung cancer association [valg] staging system);
- No previous systemic treatment for ES-SCLC;
Key exclusion criteria (8 listed)
- Symptomatic, untreated, or actively progressive central nervous system (CNS) metastases; ·Patients with CNS lesions who were treated and asymptomatic were eligible for this study if they met all of the following criteria: measurable lesions that met the recistv1.1 definition were outside the CNS; The patient had no history of intracranial hemorrhage or spinal cord hemorrhage; Patients did not receive stereotactic radiotherapy within 7 days before the start of study treatment, whole brain radiotherapy within 14 days before the start of study treatment, or neurosurgical resection within 28 days before the start of study treatment; Patients do not need to continue to receive corticosteroids for CNS disease. Treatment with stable doses of anticonvulsants was allowed. Metastasis was limited to the cerebellum or supratentorial region (i.e., not to the midbrain, pons, medulla oblongata, or spinal cord); There was no evidence of progression between the completion of CNS local therapy and the initiation of study therapy asymptomatic patients with CNS metastases who could be enrolled according to the assessment of other investigators could be enrolled;
- History of leptomeningeal disease;
- Poorly controlled pleural effusion, pericardial effusion or ascites requiring repeated drainage (once a month or more frequently);
- Poorly controlled or symptomatic hypercalcemia (ionized calcium >1.5mmol/l, calcium >12mg/dl or corrected calcium >uln);
- Have active or ever suffered from autoimmune disease or immunodeficiency;
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 |
|---|---|---|
| Tislelizumab Combined With ChemotherapyAlso: thoracic consolidation radiotherapyPatients with newly diagnosed ES-SCLC receive induction therapy (tislelizumab+EP regimen, 4-6 cycles). After completing the induction therapy, efficacy evaluation is conducted. Those who experience remission are sequentially treated with tislelizumab combined with consolidation chest radiotherapy (TRT). After the consolidation therapy is completed, tislelizumab maintenance therapy is received until disease progression, intolerable toxicity, or withdrawal of informed consent occurs, whichever occurs first. The maximum duration of treatment is 2 years. | Drug | Experimental group |
Primary outcome
progression-free survival
Time frame: From enrollment to the date of the first recorded tumor progression (assessed according to RECIST v1.1 criteria, regardless of whether treatment is continued or not) or the date of death from any cause, whichever occurs first, assessed up to 24 months.
Progression free survival (PFS): defined as the period from enrollment to the date of the first recorded tumor progression (assessed according to RECIST v1.1 criteria, regardless of whether treatment is continued or not) or the date of death from any cause, whichever occurs first, assessed up to 24 months.
4 secondary outcomes
Objective response rate
Time frame: The proportion of patients with BOR rated as CR or PR according to RECIST v1.1 criteria from the start of enrollment to progressive disease, assessed up to 24 months.
Disease control rate
Time frame: The proportion of patients who, from enrollment to progressive disease, assessed up to 24 months
Duration of remission
Time frame: From enrollment to the first recorded objective remission to recurrence or death for any reason, as determined by the researcher based on RECIST v1.1, whichever occurs first, assessed up to 24 months.
Overall survival
Time frame: The time between enrollment and death from any cause, assessed up to 24 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 23 Feb 2026.
- Results publication: PubMed 39252865Chen D, Zou B, Li B, Gao A, Huang W, Shao Q, Meng X, Zhang P, Tang X, Hu X, Zhang Y, Guo J, Zhao C, Yuan J, Li Q, Zhu C, Yu J, Wang L. Adebrelimab plus chemotherapy and sequential thoracic radiotherapy as first-line therapy for extensive-stage small-cell lung cancer (ES-SCLC): a phase II trial. EClinicalMedicine. 2024 Aug 21;75:102795. doi: 10.1016/j.eclinm.2024.102795. eCollection 2024 Sep.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab Combined With Chemotherapy in people with Extensive Stage Small Cell Lung Cancer (ES-SCLC), run by Chongqing University Cancer Hospital at 1 site in China.
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 9 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 23 Feb 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 Wei Zhou, Professor (86-13883465672, 1052308491@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: From enrollment to the date of the first recorded tumor progression (assessed according to RECIST v1.1 criteria, regardless of whether treatment is continued or not) or the date of 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 NCT07425795, which also lists 1 linked publication.
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 23 Feb 2026.