Small Cell Lung Cancer, Limited StagePhase 2NCT06784206
Adebrelimab Maintenance Therapy After Concurrent Chemoradiotherapy with Hyperfractionated Radiotherapy in Limited-Stage Small Cell Lung Cancer
A Phase 2 study testing Adebrelimab Maintenance Therapy After Concurrent Chemoradiotherapy with Hyperfractionated Radiotherapy in people with Small Cell Lung Cancer, Limited Stage and Hyperfractionated Accelerated Radiotherapy, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
Small cell lung cancer (SCLC) remains a challenging disease with poor prognosis and limited treatment options despite decades of research. SCLC is an immunogenic tumor, and the use of T-cell immune checkpoint inhibitors targeting the PD-1/PD-L1 axis has shown promising antitumor activity, potentially extending patient… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer, Limited Stage, Hyperfractionated Accelerated Radiotherapy, Simultaneous Radiotherapy and Chemotherapy
- What is being tested?
- Adebrelimab Maintenance Therapy After Concurrent Chemoradiotherapy with Hyperfractionated Radiotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Feb 2025to Jan 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
- Age: 18-75 years, both genders are eligible;
- Histologically or cytologically confirmed limited-stage small cell lung cancer (according to the 8th edition of AJCC staging);
- Patients who have previously received no more than 2 cycles of standard chemotherapy or are treatment-naive;
- ECOG performance status: 0-1;
- Presence of measurable lesions according to RECIST 1.1 criteria (for RECIST 1.1 criteria, the longest diameter of tumor lesions on CT scan ≥10mm, and the shortest diameter of lymph node lesions on CT scan ≥15mm);
- Estimated life expectancy of at least three months;
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- Participants must have adequate pulmonary function;
- Normal function of major organs, which means meeting the following criteria:
- Complete blood count:
- Hemoglobin (HGB) ≥90 g/L; Absolute neutrophil count (ANC) ≥1.5×10⁹/L; Platelet count (PLT) ≥100×10⁹/L; White blood cell count (WBC) ≥3.0×10⁹/L;
- Biochemical tests:
- Serum albumin (ALB) ≥30 g/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <3×ULN; Total bilirubin (TBIL) ≤1.5×ULN; this does not apply to patients diagnosed with Gilbert's syndrome (persistent or recurrent hyperbilirubinemia [mainly unconjugated bilirubin], without evidence of hemolysis or liver pathology). After consultation with a physician, patients with this condition may be allowed to participate in the study.
- Creatinine ≤1.5×ULN;
- Women of childbearing potential must have taken reliable contraceptive measures or have had a negative pregnancy test (serum or urine) within 7 days before enrollment. Both men and women of childbearing age must agree to take adequate contraceptive measures throughout the study period and for 6 months after the end of treatment;
- Participants voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-ups.
Who cannot join
- Histological mixture of SCLC and NSCLC components;
- Extensive-stage SCLC;
- Patients with a history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant or planned for transplant;
- Use of immunosuppressive drugs (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor drugs) within 14 days before the first use of Adebrelimab, excluding nasal and inhaled corticosteroids or physiologic doses of systemic corticosteroids (i.e., no more than 10 mg/day of prednisolone or equivalent physiologic dose of other corticosteroids);
- Known allergy to etoposide, cisplatin, Adebrelimab, or drug excipients; or severe allergic reactions to other monoclonal antibodies; Vaccination with live attenuated vaccines within 4 weeks before the first dose or planned during the study period;
- Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism) is not eligible. Exceptions to this criterion include:
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- Patients with vitiligo or alopecia;
- Patients with stable hypothyroidism under hormone replacement therapy (e.g., after Hashimoto's syndrome);
- Participants undergoing systemic treatment with bronchodilators, with unsatisfactory asthma control, are not eligible (those who had complete remission of asthma in childhood and require no intervention in adulthood may be included);
- Urinalysis showing proteinuria ≥++, or confirmed 24-hour urine protein ≥1.0g;
- Previously diagnosed with any other malignancy, except for the following conditions:
- Adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix;
- Malignancies treated with curative intent, with no known active disease for ≥5 years before the first dose in the study and with a low potential risk of recurrence;
- Infection with human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);
- Within 6 months before enrollment, occurrence of the following conditions: myocardial infarction, severe/unstable angina, NYHA class 2 or higher heart failure, poorly controlled arrhythmias (including QTcF interval >450 ms for males, >470 ms for females, QTcF interval calculated by Fridericia formula), symptomatic congestive heart failure;
- Infections requiring drug intervention (e.g., intravenous antibiotics, antifungal, or antiviral drugs) within 4 weeks before the first dose, or unexplained fever ≥38.5°C during the screening period or before the first dose;
- 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 analytical method), or co-infection with hepatitis B and C;
- Participation in any other drug clinical trial within 4 weeks before the first dose; Known history of abuse of psychoactive drugs or drug addiction;
- Presence of other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participation in the study, interfere with the study results, or patients whom the investigator deems unsuitable for participation in this 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.
China1 site
Peking University Cancer Hospital and Institute
Beijing, Beijing Municipality, 100142
AnHui -Shi, MD, 139 0113 6511, anhuidoctor@163.com
About this study
Official title: An Exploratory Clinical Study of Adebrelimab Maintenance Treatment Following Concurrent Chemoradiotherapy with Hyperfractionated Radiotherapy in Patients with Limited-Stage Small Cell Lung Cancer
Small cell lung cancer (SCLC) remains a challenging disease with poor prognosis and limited treatment options despite decades of research. SCLC is an immunogenic tumor, and the use of T-cell immune checkpoint inhibitors targeting the PD-1/PD-L1 axis has shown promising antitumor activity, potentially extending patient survival. The combination of concurrent chemoradiotherapy followed by immune maintenance therapy has demonstrated significant efficacy in limited-stage SCLC. Moreover, hyperfractionated accelerated radiotherapy (HART) has been shown to improve overall survival in limited-stage SCLC compared to standard dose radiotherapy without increasing toxicity. However, there is a lack of exploration into the use of immune checkpoint inhibitors following concurrent chemoradiotherapy with HART in limited-stage SCLC.
This exploratory clinical study aims to investigate the efficacy and safety of adebrelimab maintenance treatment following concurrent chemoradiotherapy with HART in patients with limited-stage SCLC through a single-arm, open-label, prospective, single-center clinical trial.
- Conditions
- Small Cell Lung Cancer, Limited Stage, Hyperfractionated Accelerated Radiotherapy, Simultaneous Radiotherapy and Chemotherapy
- Being tested
- Adebrelimab Maintenance Therapy After Concurrent Chemoradiotherapy with Hyperfractionated 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.
Adebrelimab Maintenance Therapy After Concurrent Chemoradiotherapy with Hyperfractionated RadiotherapyDrug
Chemotherapy:
Etoposide will be administered intravenously at a dose of 100 mg/m² on days 1 to 3 of each cycle. Cisplatin will be given at a dose of 75 mg/m² on day 1 of each cycle. The treatment will be repeated every 3 weeks for a total of 4 cycles.
Concurrent Radiotherapy:
Chest radiotherapy will be initiated concurrently with the first 3 cycles of chemotherapy. The total dose of radiotherapy will be 54 Gy, delivered in 30 fractions, with 2 fractions per day.
Prophylactic Cranial Irradiation (PCI):
For patients who achieve a partial response (PR) or complete response (CR) after chemoradiotherapy, PCI will be administered 3 to 4 weeks after the completion of chemoradiotherapy. The dose for PCI will be 25 Gy in 10 fractions.
Adebrelimab Maintenance Therapy:
Following PCI, patients will receive maintenance therapy with Adebrelimab. The dose will be 1200 mg administered intravenously on day 1 of each cycle. The treatment will be repeated every 3 weeks until disease progression, death
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | In this study, patients will receive concurrent hyperfractionated accelerated radiotherapy (HART) combined with chemotherapy for 4 cycles. If patients achieve a complete response (CR) or partial response (PR) after the initial treatment, they will be given prophylactic cranial irradiation (PCI). Following PCI, patients will enter the maintenance treatment phase with Adebrelimab, which will continue until disease progression, death, or the development of intolerable toxicity. Receives: Drug: Adebrelimab Maintenance Therapy After Concurrent Chemoradiotherapy with Hyperfractionated Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related adverse events
Treatment-related adverse events according to CTCAE 5.0
Measured: Duration of treatment and follow up until death or 90 days after enrollment
Secondary outcomes (4)
PFS
From the date of enrollment to the date of disease progression
Measured: From enrollment to the end of treatment at 1 and 2 year
OS
from the date of enrollment until death by any cause or last follow-up
Measured: From date of enrollment to maximum of 2 years or death
ORR
The proportion of subjects with Best Overall Response (BOR) assessed as Complete Response (CR) or Partial Response (PR) according to RECIST 1.1 criteria
Measured: From date of enrollment to maximum of 2 years
DCR
DCR is defined as the proportion of subjects with CR, PR, or stable disease (SD) based on RECIST v1.1.
Measured: From date of enrollment to maximum of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionJan 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 Cancer, Limited StageStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anhui Shi, MD, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784206
- Sponsor's protocol ID
- 2024YJZ163
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of Adebrelimab Maintenance Treatment Following Concurrent Chemoradiotherapy with Hyperfractionated Radiotherapy in Patients with Limited-Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06784206
- Acronym / sponsor ID
- 2024YJZ163
- Conditions
- Small Cell Lung Cancer, Limited Stage, Hyperfractionated Accelerated Radiotherapy, Simultaneous Radiotherapy and Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 20 Jan 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.
Small cell lung cancer (SCLC) remains a challenging disease with poor prognosis and limited treatment options despite decades of research. SCLC is an immunogenic tumor, and the use of T-cell immune checkpoint inhibitors targeting the PD-1/PD-L1 axis has shown promising antitumor activity, potentially extending patient survival. The combination of concurrent chemoradiotherapy followed by immune maintenance therapy has demonstrated significant efficacy in limited-stage SCLC. Moreover, hyperfractionated accelerated radiotherapy (HART) has been shown to improve overall survival in limited-stage SCLC compared to standard dose radiotherapy without increasing toxicity. However, there is a lack of exploration into the use of immune checkpoint inhibitors following concurrent chemoradiotherapy with HART in limited-stage SCLC.
This exploratory clinical study aims to investigate the efficacy and safety of adebrelimab maintenance treatment following concurrent chemoradiotherapy with HART in patients with limited-stage SCLC through a single-arm, open-label, prospective, single-center clinical trial.
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: Adebrelimab Maintenance Therapy After Concurrent Chemoradiotherapy with Hyperfractionated RadiotherapyIn this study, patients will receive concurrent hyperfractionated accelerated radiotherapy (HART) combined with chemotherapy for 4 cycles. If patients achieve a complete response (CR) or partial response (PR) after the initial treatment, they will be given prophylactic cranial irradiation (PCI). Following PCI, patients will enter the maintenance treatment phase with Adebrelimab, which will continue until disease progression, death, or the development of intolerable toxicity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age: 18-75 years, both genders are eligible;
- Histologically or cytologically confirmed limited-stage small cell lung cancer (according to the 8th edition of AJCC staging);
- Patients who have previously received no more than 2 cycles of standard chemotherapy or are treatment-naive;
- ECOG performance status: 0-1;
- Presence of measurable lesions according to RECIST 1.1 criteria (for RECIST 1.1 criteria, the longest diameter of tumor lesions on CT scan ≥10mm, and the shortest diameter of lymph node lesions on CT scan ≥15mm);
Key exclusion criteria (19 listed)
- Histological mixture of SCLC and NSCLC components;
- Extensive-stage SCLC;
- Patients with a history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant or planned for transplant;
- Use of immunosuppressive drugs (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor drugs) within 14 days before the first use of Adebrelimab, excluding nasal and inhaled corticosteroids or physiologic doses of systemic corticosteroids (i.e., no more than 10 mg/day of prednisolone or equivalent physiologic dose of other corticosteroids);
- Known allergy to etoposide, cisplatin, Adebrelimab, or drug excipients; or severe allergic reactions to other monoclonal antibodies; Vaccination with live attenuated vaccines within 4 weeks before the first dose or planned during the study period;
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 Maintenance Therapy After Concurrent Chemoradiotherapy with Hyperfractionated RadiotherapyChemotherapy: Etoposide will be administered intravenously at a dose of 100 mg/m² on days 1 to 3 of each cycle. Cisplatin will be given at a dose of 75 mg/m² on day 1 of each cycle. The treatment will be repeated every 3 weeks for a total of 4 cycles. Concurrent Radiotherapy: Chest radiotherapy will be initiated concurrently with the first 3 cycles of chemotherapy. The total dose of radiotherapy will be 54 Gy, delivered in 30 fractions, with 2 fractions per day. Prophylactic Cranial Irradiation (PCI): For patients who achieve a partial response (PR) or complete response (CR) after chemoradiotherapy, PCI will be administered 3 to 4 weeks after the completion of chemoradiotherapy. The dose for PCI will be 25 Gy in 10 fractions. Adebrelimab Maintenance Therapy: Following PCI, patients will receive maintenance therapy with Adebrelimab. The dose will be 1200 mg administered intravenously on day 1 of each cycle. The treatment will be repeated every 3 weeks until disease progression, death | Drug | experimental group |
Primary outcome
Treatment-related adverse events
Time frame: Duration of treatment and follow up until death or 90 days after enrollment
Treatment-related adverse events according to CTCAE 5.0
4 secondary outcomes
PFS
Time frame: From enrollment to the end of treatment at 1 and 2 year
OS
Time frame: From date of enrollment to maximum of 2 years or death
ORR
Time frame: From date of enrollment to maximum of 2 years
DCR
Time frame: From date of enrollment to maximum of 2 years
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 20 Jan 2025.
- Individual participant dataSharing planned: Yes
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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 Adebrelimab Maintenance Therapy After Concurrent Chemoradiotherapy with Hyperfractionated Radiotherapy in people with Small Cell Lung Cancer, Limited Stage and Hyperfractionated Accelerated Radiotherapy, 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 15 inclusion and 19 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 20 Jan 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.
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 AnHui Shi, MD (139 0113 6511, anhuidoctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-related adverse events (time frame: Duration of treatment and follow up until death or 90 days after enrollment). 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 20 Jan 2025.