Small Cell Lung CarcinomaPhase 2NCT07357532
Exploration of Treatment Strategies After Concurrent Chemoradiotherapy for LS-SCLC Guided by MRD
A Phase 2 study testing Adebrelimab Injection and Apatinib Mesylate Tablets in people with Small Cell Lung Carcinoma, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
This study plans to enroll limited-stage small cell lung cancer (LS-SCLC) patients who have achieved disease control after concurrent chemoradiotherapy (cCRT). Tissue samples collected at initial diagnosis and serial peripheral blood samples obtained at multiple post-cCRT timepoints will be analyzed using targeted… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Small Cell Lung Carcinoma
- What is being tested?
- Adebrelimab Injection and Apatinib Mesylate Tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2026to 30 Oct 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent; age >18 and <80 years;
- Histologically or cytologically confirmed limited-stage small cell lung cancer (LS-SCLC);
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1;
- Patients who have achieved disease stabilization after concurrent or sequential chemoradiotherapy;
- Patients who had not received previous immune checkpoint inhibitor treatment;
- Patients with MRD-positive status following concurrent chemoradiotherapy;
- Willingness to provide clinical-pathological data, imaging studies, and other required materials for research purposes; compliance with follow-up procedures, including blood sample collection at predefined efficacy evaluation timepoints; and agreement to use the collected data for subsequent research analyses.
Who cannot join
- Have other malignant tumors;
- Autoimmune disorders that are not amenable to PD-L1 inhibitor therapy;
- Prior exposure to other anti-angiogenic small molecule TKIs such as erlotinib or anti-angiogenic monoclonal antibodies such as bevacizumab (except locally infused bevacizumab); or participation in a clinical trial of another antineoplastic agent within 4 weeks prior to the first dose of ; or prior treatment with a paclitaxel;
- Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg despite optimal pharmacologic therapy);
- Class II or greater myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc intervals ≥450 ms in men and ≥470 ms in women). According to NYHA criteria, grade III-IV cardiac insufficiency, or cardiac color ultrasound suggests that the left ventricular ejection fraction (LVEF) is <50% have had a myocardial infarction within 6 months prior to enrollment, New York Heart Association class II or higher heart failure, uncontrolled angina pectoris, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or ECG suggestive of acute ischemia or active conduction system abnormalities; (6) uncontrolled angina pectoris, uncontrolled severe ventricular arrhythmias, clinically significant pericardial disease, or ECG suggestive of acute ischemia or active conduction system abnormalities.
- Uncontrolled co-morbidities including, but not limited to, poorly controlled diabetes mellitus, diabetic peripheral lesions , persistent infections, or psychiatric or social conditions that may interfere with the subject's ability to comply;
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- Abnormal coagulation (INR > 1.5 or Prothrombin Time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), hemorrhagic symptoms, or on thrombolytic or anticoagulant therapy;
- Known hereditary or acquired bleeding and thrombotic disorders such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.;
- Significant coughing up of fresh blood or hemoptysis of one-half teaspoon (2.5 ml) per day or more within 2 months prior to entry into the study ;
- Failure to receive specified treatment or change in treatment regimen prior to disease progression;
- Unable to cooperate with the study in accordance with the established clinical follow-up period;
- Unable to accept or provide the specified means of efficacy assessment such as imaging.
- Pregnant or lactating women.
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
Peking University Cancer Hospital & Institute
Beijing
Jun Zhao, 88196456, ohjerry@163.com
About this study
Official title: Exploration of Treatment Strategies After Concurrent Chemoradiotherapy for Limited-stage Small Cell Lung Cancer (LS-SCLC) Guided by Molecular Residual Disease (MRD)
This study plans to enroll limited-stage small cell lung cancer (LS-SCLC) patients who have achieved disease control after concurrent chemoradiotherapy (cCRT). Tissue samples collected at initial diagnosis and serial peripheral blood samples obtained at multiple post-cCRT timepoints will be analyzed using targeted next-generation sequencing to investigate the correlation between molecular residual disease (MRD) status and tumor recurrence/metastasis. For patients with MRD-positive results, a therapeutic strategy combining immunotherapy with anti-angiogenic agents will be implemented with the aim of improving clinical outcomes.
- Conditions
- Small Cell Lung Carcinoma
- Being tested
- Adebrelimab Injection, Apatinib Mesylate Tablets
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab InjectionDrug
Also called Ai Rui Li
Patients with MRD Positive will receive adebrelimab (1200 mg, D1, Q3W) , followed by ctDNA monitoring every 2 months (Year 1) and every 3 months (Year 2).The above treatment regimen will be maintained until disease progression, intolerable toxicity, completion of two years of treatment, subject-initiated withdrawal, or investigator-determined discontinuation.
Apatinib Mesylate TabletsDrug
Also called Ai Tan
Apatinib Mesylate Tablets (250 mg, QD) , followed by ctDNA monitoring every 2 months (Year 1) and every 3 months (Year 2).The above treatment regimen will be maintained until disease progression, intolerable toxicity, completion of two years of treatment, subject-initiated withdrawal, or investigator-determined discontinuation.
| Study group | Role | What they receive |
|---|---|---|
| MRD-positive group | Experimental | The specific dosing regimen is as follows:
Adebrelimab: Intravenous infusion, 1200 mg, administered on Day 1 of each cycle, once every 3 weeks.
Apatinib: Oral administration, 250 mg, once daily. Patients with limited-stage small cell lung cancer who have completed all radical chemoradiotherapy (prophylactic cranial irradiation is permitted) and test positive for MRD upon enrollment, without prior use of immune checkpoint inhibitors, will receive adebrelimab combined with apatinib according to the above dosing regimen. Treatment with adebrelimab and apatinib will continue, along with ongoing ctDNA monitoring. The above treatment regimen will be maintained until disease progression, intolerable toxicity, completion of two years of treatment, subject-initiated withdrawal, or investigator-determined discontinuation. Receives: Drug: Adebrelimab Injection; Drug: Apatinib Mesylate Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative conversion rate of MRD
Patients with limited-stage small cell lung cancer (LS-SCLC) receive concurrent chemoradiotherapy in accordance with standard diagnostic and treatment guidelines. Patients who are MRD-positive after completion of concurrent chemoradiotherapy and have not previously been treated with immune checkpoint inhibitors are screened and enrolled to receive the investigational treatment regimen. We then calculate the proportion of patients whose MRD status converts from positive to negative following treatment.
Measured: MRD is assessed at 60-day intervals during the first year and 90-day intervals during the second year, until disease progression, study discontinuation for any reason, or completion of 2 years of follow-up, whichever occurs first.
Secondary outcomes (4)
PFS
Progression-Free Survival (PFS) is defined as the time interval from randomization (or treatment initiation in single-arm studies) to the first occurrence of either: Radiographically or pathologically confirmed disease progression（RECIST1.1）, or Death from any cause; whichever is observed first.
Measured: Imaging assessments are performed every 3 months. After each assessment, treatment response is evaluated by senior experts according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. The maximum follow-up duration is 2 years.
OS
Overall Survival (OS) is defined as the time interval from randomization (or treatment initiation in single-arm studies) to death from any cause.
Measured: Imaging assessments are performed every 3 months. After each assessment, treatment response is evaluated by senior experts according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. The maximum follow-up duration is 2 years.
Time to conversion to MRD negativity
Patients with limited-stage small cell lung cancer (LS-SCLC) receive concurrent chemoradiotherapy in accordance with standard diagnostic and treatment guidelines. Patients who are MRD-positive after concurrent chemoradiotherapy and have no prior exposure to immune checkpoint inhibitors are screened and enrolled to receive the investigational treatment regimen. The time required for MRD conversion from positive to negative following treatment is calculated, measured in days.
Measured: MRD is assessed at 60-day intervals during the first year and 90-day intervals during the second year, until disease progression, study discontinuation for any reason, or completion of 2 years of follow-up, whichever occurs first.
Duration of negative conversion after medication in MRD-positive patients
Patients with limited-stage small cell lung cancer (LS-SCLC) receive concurrent chemoradiotherapy in accordance with standard diagnostic and treatment guidelines. Patients who are MRD-positive after concurrent chemoradiotherapy and have no prior exposure to immune checkpoint inhibitors are screened and enrolled to receive the investigational treatment regimen. The duration of MRD negativity after treatment-defined as the time from conversion to MRD-negative status to subsequent reversion to MRD-positive status, if applicable-is calculated and measured in days.
Measured: MRD is assessed at 60-day intervals during the first year and 90-day intervals during the second year, until disease progression, study discontinuation for any reason, or completion of 2 years of follow-up, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start31 Jan 2026 (estimated)
- Primary completion26 Sep 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- MRD-positive subjects will receive treatment with adebrelimab (anti-PD-L1) combined with apatinib (anti-angiogenic therapy),with close monitoring for disease progression.
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Zhao, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357532
- Sponsor's protocol ID
- 2025YJZ103
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Treatment Strategies After Concurrent Chemoradiotherapy for Limited-stage Small Cell Lung Cancer (LS-SCLC) Guided by Molecular Residual Disease (MRD)
- ClinicalTrials.gov ID
- NCT07357532
- Acronym / sponsor ID
- 2025YJZ103
- Conditions
- Small Cell Lung Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- 26 Sep 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 22 Jan 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 plans to enroll limited-stage small cell lung cancer (LS-SCLC) patients who have achieved disease control after concurrent chemoradiotherapy (cCRT). Tissue samples collected at initial diagnosis and serial peripheral blood samples obtained at multiple post-cCRT timepoints will be analyzed using targeted next-generation sequencing to investigate the correlation between molecular residual disease (MRD) status and tumor recurrence/metastasis. For patients with MRD-positive results, a therapeutic strategy combining immunotherapy with anti-angiogenic agents will be implemented with the aim of improving clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- MRD-positive subjects will receive treatment with adebrelimab (anti-PD-L1) combined with apatinib (anti-angiogenic therapy),with close monitoring for disease progression.
| Arm | Type | Receives |
|---|---|---|
| MRD-positive group | Experimental | Drug: Adebrelimab Injection, Drug: Apatinib Mesylate TabletsThe specific dosing regimen is as follows: Adebrelimab: Intravenous infusion, 1200 mg, administered on Day 1 of each cycle, once every 3 weeks. Apatinib: Oral administration, 250 mg, once daily. Patients with limited-stage small cell lung cancer who have completed all radical chemoradiotherapy (prophylactic cranial irradiation is permitted) and test positive for MRD upon enrollment, without prior use of immune checkpoint inhibitors, will receive adebrelimab combined with apatinib according to the above dosing regimen. Treatment with adebrelimab and apatinib will continue, along with ongoing ctDNA monitoring. The above treatment regimen will be maintained until disease progression, intolerable toxicity, completion of two years of treatment, subject-initiated withdrawal, or investigator-determined discontinuation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent; age >18 and <80 years;
- Histologically or cytologically confirmed limited-stage small cell lung cancer (LS-SCLC);
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1;
- Patients who have achieved disease stabilization after concurrent or sequential chemoradiotherapy;
- Patients who had not received previous immune checkpoint inhibitor treatment;
Key exclusion criteria (13 listed)
- Have other malignant tumors;
- Autoimmune disorders that are not amenable to PD-L1 inhibitor therapy;
- Prior exposure to other anti-angiogenic small molecule TKIs such as erlotinib or anti-angiogenic monoclonal antibodies such as bevacizumab (except locally infused bevacizumab); or participation in a clinical trial of another antineoplastic agent within 4 weeks prior to the first dose of ; or prior treatment with a paclitaxel;
- Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg despite optimal pharmacologic therapy);
- Class II or greater myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc intervals ≥450 ms in men and ≥470 ms in women). According to NYHA criteria, grade III-IV cardiac insufficiency, or cardiac color ultrasound suggests that the left ventricular ejection fraction (LVEF) is <50% have had a myocardial infarction within 6 months prior to enrollment, New York Heart Association class II or higher heart failure, uncontrolled angina pectoris, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or ECG suggestive of acute ischemia or active conduction system abnormalities; (6) uncontrolled angina pectoris, uncontrolled severe ventricular arrhythmias, clinically significant pericardial disease, or ECG suggestive of acute ischemia or active conduction system abnormalities.
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 |
|---|---|---|
| Adebrelimab InjectionAlso: Ai Rui LiPatients with MRD Positive will receive adebrelimab (1200 mg, D1, Q3W) , followed by ctDNA monitoring every 2 months (Year 1) and every 3 months (Year 2).The above treatment regimen will be maintained until disease progression, intolerable toxicity, completion of two years of treatment, subject-initiated withdrawal, or investigator-determined discontinuation. | Drug | MRD-positive group |
| Apatinib Mesylate TabletsAlso: Ai TanApatinib Mesylate Tablets (250 mg, QD) , followed by ctDNA monitoring every 2 months (Year 1) and every 3 months (Year 2).The above treatment regimen will be maintained until disease progression, intolerable toxicity, completion of two years of treatment, subject-initiated withdrawal, or investigator-determined discontinuation. | Drug | MRD-positive group |
Primary outcome
Negative conversion rate of MRD
Time frame: MRD is assessed at 60-day intervals during the first year and 90-day intervals during the second year, until disease progression, study discontinuation for any reason, or completion of 2 years of follow-up, whichever occurs first.
Patients with limited-stage small cell lung cancer (LS-SCLC) receive concurrent chemoradiotherapy in accordance with standard diagnostic and treatment guidelines. Patients who are MRD-positive after completion of concurrent chemoradiotherapy and have not previously been treated with immune checkpoint inhibitors are screened and enrolled to receive the investigational treatment regimen. We then calculate the proportion of patients whose MRD status converts from positive to negative following treatment.
4 secondary outcomes
PFS
Time frame: Imaging assessments are performed every 3 months. After each assessment, treatment response is evaluated by senior experts according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. The maximum follow-up duration is 2 years.
OS
Time frame: Imaging assessments are performed every 3 months. After each assessment, treatment response is evaluated by senior experts according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. The maximum follow-up duration is 2 years.
Time to conversion to MRD negativity
Time frame: MRD is assessed at 60-day intervals during the first year and 90-day intervals during the second year, until disease progression, study discontinuation for any reason, or completion of 2 years of follow-up, whichever occurs first.
Duration of negative conversion after medication in MRD-positive patients
Time frame: MRD is assessed at 60-day intervals during the first year and 90-day intervals during the second year, until disease progression, study discontinuation for any reason, or completion of 2 years of follow-up, whichever occurs first.
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 22 Jan 2026.
- 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.
Jun Zhao principal investigator
Peking University Cancer Hospital & Institute
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 Adebrelimab Injection and Apatinib Mesylate Tablets in people with Small Cell Lung Carcinoma, run by Peking University Cancer Hospital & Institute 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 7 inclusion and 13 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 22 Jan 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 Jun Zhao (13521469355, ohjerry@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative conversion rate of MRD (time frame: MRD is assessed at 60-day intervals during the first year and 90-day intervals during the second year, until disease progression, study discontinuation for any reason, or completion of 2 years of follow-up, whichever occurs first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2026.