Limited-stage Small Cell Lung Cancer (LS-SCLC)NCT06869239
Prediction of Response to PD-L1 Inhibitor After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer Using Multi-omics-based Liquid Biopsy
An observational study of Limited-stage Small Cell Lung Cancer (LS-SCLC), run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
This study aims to explore the efficacy and safety of immunotherapy (PD-L1 inhibitor) maintenance following high-dose hyperfractionated simultaneous integrated boost radiotherapy concurrent chemotherapy in patients with limited-stage small cell lung cancer (LS-SCLC). This study is a prospective observational study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Limited-stage Small Cell Lung Cancer (LS-SCLC)
- What is being tested?
- Etoposide + cisplatin/carboplatin, Thoracic radiotherapy and Prophylactic cranial irradiation (PCI)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2025to 3 Jan 2028
- Phase
- Observational
- 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
Study population: LS-SCLC with PD-L1 inhibitor after Chemoradiotherapy
Who may be able to join
- 1. Age 18-75 years, male or female;
- 2. Histologically or cytologically confirmed limited-stage small cell lung cancer (LS-SCLC) (AJCC, 8th edition);
- 3. No more than 2 cycles of chemotherapy or no previous systemic therapy;
- 4. ECOG PS 0-1;
- 5. Measurable disease, as defined by RECIST v1.1 (tumor lesions long axis≥10mm, lymph nodes short axis ≥15mm);
- 6. Life expectancy ≥3 months;
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- 7. Adequate pulmonary function;
- 8. Adequate hematologic and end-organ function, defined by the following criteria:
- Hematology
- Hemoglobin (HGB) ≥90 g/L;
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L;
- Platelet count (PLT) ≥ 100 x 10^9/L;
- White blood cell count (WBC) ≥ 3.0 x 10^9/L;
- Serum chemistry
- Serum albumin (ALB) ≥ 30 g/L;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3 x ULN;
- Total bilirubin (TBIL) ≤1.5 ULN; Note: Patients diagnosed with Gilbert's syndrome (persistent or recurrent hyperbilirubinemia [mainly unconjugated bilirubin] without evidence of hemolysis or liver pathology) after consultation with their physician can be allowed;
- Creatinine ≤ 1.5 ULN;
- 9. Women of childbearing age must have taken reliable contraceptive measures or undergone a negative pregnancy test (serum or urine) within 7 days prior to enrollment. Both men and women of childbearing age must agree to maintain adequate contraceptive measures throughout the study and for 6 months following the completion of treatment;
- 10. Patients must voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and actively cooperate with follow-up procedures.
Who cannot join
- 1. Histological mixture of SCLC and NSCLC components;
- 2. Extensive-stage SCLC;
- 3. Patients with a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or those planned for transplantation;
- 4. Treatment with immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 14 days prior to the first dose of PD-L1 inhibitor, except for intranasal and inhaled corticosteroids or low-dose systemic steroids (i.e., ≤10 mg/day prednisolone or equivalent);
- 5. History of hypersensitivity to etoposide, cisplatin, PD-L1 antibody, or excipients in the formulation; or history of severe allergic reactions to other monoclonal antibodies;
- 6. Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during study treatment;
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- 7. Active or history of autoimmune disease or immune deficiency (including but not limited to autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism);
- Note:
- Patients with vitiligo or alopecia are eligible for this study;
- Patients with stable hypothyroidism undergoing hormone replacement therapy (e.g., Hashimoto's syndrome) are eligible for this study;
- 8. Poorly controlled asthma despite systemic treatment, such as bronchodilators; Note: Patients with complete remission of asthma during childhood and no need for any intervention in adulthood can be allowed;
- 9. Urinalysis shows proteinuria ≥ ++ or confirmed 24-hour urine protein ≥ 1.0g;
- 10. Malignancies other than LS-SCLC, with the following exceptions:
- Adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix;
- Malignancy that has been treated with curative intent, with no known active disease for ≥5 years prior to the first dose of the study treatment, and with a low potential risk of recurrence;
- 11. Human immunodeficiency virus (HIV) infection or known to have acquired immunodeficiency syndrome (AIDS);
- 12. Significant cardiovascular disease within 6 months prior to enrollment, such as myocardial infarction, severe/unstable angina, New York Heart Association cardiac disease (class II or greater), poorly controlled arrhythmias (including QTcF interval >450 ms for males and >470 ms for females, with QTcF interval calculated using the Fridericia formula), and symptomatic congestive heart failure;
- 13. Severe infections within 4 weeks prior to first dose of study treatment, including but not limited to infections requiring intravenous antibiotics, antifungal, or antiviral agents , or unexplained fever ≥38.5°C occurring during the screening period or before the first dose of the study treatment;
- 14. Active tuberculosis, hepatitis B (HBV-DNA ≥ 500 IU/ml), hepatitis C (positive hepatitis C antibody and HCV-RNA above the lower limit of detection of the assay), or co-infection with both hepatitis B and C;
- 15. Treatment with any other investigational agent with therapeutic intent within 4 weeks prior to the first dose of the study treatment;
- 16. History of abuse of psychotropic drugs or drug addiction;
- 17. Patients with other severe physical or mental illnesses or abnormal laboratory test results that may increase the risk of participating in the study, or interfere with the study results, as well as those whom the investigator deems unsuitable for participation in the study for other reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jiayi Yu contact
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, 100142
Anhui Shi, 8601088196087, anhuidoctor@163.com
Jiayi Yu, 8601088196087
About this study
This study aims to explore the efficacy and safety of immunotherapy (PD-L1 inhibitor) maintenance following high-dose hyperfractionated simultaneous integrated boost radiotherapy concurrent chemotherapy in patients with limited-stage small cell lung cancer (LS-SCLC). This study is a prospective observational study. Additionally, liquid biopsy technology will be employed to identify biomarkers that can predict the efficacy of PD-L1 inhibitor after chemoradiotherapy in LS-SCLC.
- Being tested
- Etoposide + cisplatin/carboplatin, Thoracic radiotherapy, Prophylactic cranial irradiation (PCI), PD-L1 inhibitor
- Keywords
- LS-SCLC, immunotherapy, liquid biopsy, high-dose radiotherapy
- 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.
Etoposide + cisplatin/carboplatinDrug
Four courses of intravenous cisplatin (75 mg/m² of body surface area on day 1 or divided into 3 days of each cycle) or carboplatin (area under the curve of 5 mg/mL per min on day 1 of each cycle) and intravenous etoposide (100 mg/m² of body surface area on days 1-3) every 3 weeks
Thoracic radiotherapyRadiation
High-dose, accelerated, hyperfractionated, twice-daily thoracic radiotherapy (54 Gy in 30 fractions) concurrent with chemotherapy initiated at the beginning of cycles 1-3
Prophylactic cranial irradiation (PCI)Radiation
PCI (25Gy in 10 fractions, once daily over two weeks) 3-4 weeks post-chemoradiotherapy for patients achieving PR or CR
PD-L1 inhibitorDrug
Maintenance therapy with PD-L1 inhibitors (Durvalumab 1500 mg Q4W or Atezolizumab 1200 mg Q3W or Sugemalimab 1200 mg Q3W or Adebrelimab 1200 mg Q3W) post-PCI until disease progression, death, or intolerable toxicity, up to 2 years
| Study group | Role | What they receive |
|---|---|---|
| PD-L1 inhibitor after chemoradiotherapy | PD-L1 inhibitor maintenance following high-dose hyperfractionated simultaneous integrated boost radiotherapy concurrent chemotherapy in patients with limited-stage small cell lung cancer Receives: Drug: Etoposide + cisplatin/carboplatin; Radiation: Thoracic radiotherapy; Radiation: Prophylactic cranial irradiation (PCI); Drug: PD-L1 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The time from enrollment to disease progression or death due to any cause, whichever occurs first.
Measured: From enrollment to disease progression or death due to any cause, whichever occurs first, assessed up to 3 years.
Secondary outcomes (4)
Overall survival
The time from enrollment to death due to any cause.
Measured: The time from enrollment to death due to any cause, assessed up to 3 years.
Objective response rate
The percentage of participants who have a CR or a PR, as determined by investigators according to RECIST v1.1.
Measured: Up to 3 years
Disease control rate
The percentage of participants who have a CR, a PR or a SD, as determined by investigators according to RECIST v1.1.
Measured: Up to 3 years
Incidence and severity of adverse events
Measured: From enrollment to 30 days after the end of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start25 Feb 2025
- Primary completion3 Jan 2027 (estimated)
- Study completion3 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limited-stage Small Cell Lung Cancer (LS-SCLC)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869239
- Sponsor's protocol ID
- BRWEP2024W032150110
- Status last verified
- Feb 2025
- First submitted
- 5 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD related to article disclosure data
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Response to PD-L1 Inhibitor After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer Using Multi-omics-based Liquid Biopsy
- ClinicalTrials.gov ID
- NCT06869239
- Acronym / sponsor ID
- BRWEP2024W032150110
- Keywords
- LS-SCLC, immunotherapy, liquid biopsy, high-dose radiotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 3 Jan 2027 (estimated)
- Study completion
- 3 Jan 2028 (estimated)
- First posted
- 11 Mar 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.
This study aims to explore the efficacy and safety of immunotherapy (PD-L1 inhibitor) maintenance following high-dose hyperfractionated simultaneous integrated boost radiotherapy concurrent chemotherapy in patients with limited-stage small cell lung cancer (LS-SCLC). This study is a prospective observational study. Additionally, liquid biopsy technology will be employed to identify biomarkers that can predict the efficacy of PD-L1 inhibitor after chemoradiotherapy in LS-SCLC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD-L1 inhibitor after chemoradiotherapy | – | Drug: Etoposide + cisplatin/carboplatin, Radiation: Thoracic radiotherapy, Radiation: Prophylactic cranial irradiation (PCI), Drug: PD-L1 inhibitorPD-L1 inhibitor maintenance following high-dose hyperfractionated simultaneous integrated boost radiotherapy concurrent chemotherapy in patients with limited-stage small cell lung cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- LS-SCLC with PD-L1 inhibitor after Chemoradiotherapy
Key inclusion criteria (20 listed)
- 1. Age 18-75 years, male or female;
- 2. Histologically or cytologically confirmed limited-stage small cell lung cancer (LS-SCLC) (AJCC, 8th edition);
- 3. No more than 2 cycles of chemotherapy or no previous systemic therapy;
- 4. ECOG PS 0-1;
- 5. Measurable disease, as defined by RECIST v1.1 (tumor lesions long axis≥10mm, lymph nodes short axis ≥15mm);
Key exclusion criteria (22 listed)
- 1. Histological mixture of SCLC and NSCLC components;
- 2. Extensive-stage SCLC;
- 3. Patients with a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or those planned for transplantation;
- 4. Treatment with immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 14 days prior to the first dose of PD-L1 inhibitor, except for intranasal and inhaled corticosteroids or low-dose systemic steroids (i.e., ≤10 mg/day prednisolone or equivalent);
- 5. History of hypersensitivity to etoposide, cisplatin, PD-L1 antibody, or excipients in the formulation; or history of severe allergic reactions to other monoclonal antibodies;
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 |
|---|---|---|
| Etoposide + cisplatin/carboplatinFour courses of intravenous cisplatin (75 mg/m² of body surface area on day 1 or divided into 3 days of each cycle) or carboplatin (area under the curve of 5 mg/mL per min on day 1 of each cycle) and intravenous etoposide (100 mg/m² of body surface area on days 1-3) every 3 weeks | Drug | PD-L1 inhibitor after chemoradiotherapy |
| Thoracic radiotherapyHigh-dose, accelerated, hyperfractionated, twice-daily thoracic radiotherapy (54 Gy in 30 fractions) concurrent with chemotherapy initiated at the beginning of cycles 1-3 | Radiation | PD-L1 inhibitor after chemoradiotherapy |
| Prophylactic cranial irradiation (PCI)PCI (25Gy in 10 fractions, once daily over two weeks) 3-4 weeks post-chemoradiotherapy for patients achieving PR or CR | Radiation | PD-L1 inhibitor after chemoradiotherapy |
| PD-L1 inhibitorMaintenance therapy with PD-L1 inhibitors (Durvalumab 1500 mg Q4W or Atezolizumab 1200 mg Q3W or Sugemalimab 1200 mg Q3W or Adebrelimab 1200 mg Q3W) post-PCI until disease progression, death, or intolerable toxicity, up to 2 years | Drug | PD-L1 inhibitor after chemoradiotherapy |
Primary outcome
Progression-free survival
Time frame: From enrollment to disease progression or death due to any cause, whichever occurs first, assessed up to 3 years.
The time from enrollment to disease progression or death due to any cause, whichever occurs first.
4 secondary outcomes
Overall survival
Time frame: The time from enrollment to death due to any cause, assessed up to 3 years.
Objective response rate
Time frame: Up to 3 years
Disease control rate
Time frame: Up to 3 years
Incidence and severity of adverse events
Time frame: From enrollment to 30 days after the end of study treatment.
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 11 Mar 2025.
- Individual participant dataSharing planned: Yes. IPD related to article disclosure data
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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.
Jiayi Yu contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Limited-stage Small Cell Lung Cancer (LS-SCLC), 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 20 inclusion and 22 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 11 Mar 2025. 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.
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 Anhui Shi (8601088196087, anhuidoctor@163.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 disease progression or death due to any cause, whichever occurs first, assessed up to 3 years.). 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 11 Mar 2025.