Efficacy and Safety of Neoadjuvant Immunotherapy for Small Cell Lung CancerPhase 2NeoadjuvantNCT06562920
Adebrelimab Combined With Chemotherapy and Concurrent SBRT for Neoadjuvant Treatment of Limited-stage Small Cell Lung Cancer
A Phase 2 study testing adebrelimab and chemotherapy in people with Efficacy and Safety of Neoadjuvant Immunotherapy for Small Cell Lung Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
To explore the effectiveness and safety of adebrelimab combined with chemotherapy and concurrent SBRT for 3 cycles of neoadjuvant treatment followed by surgery in T1-3N0-1M0 limited-stage SCLC Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Efficacy and Safety of Neoadjuvant Immunotherapy for Small Cell Lung Cancer
- What is being tested?
- adebrelimab and chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 24 Jul 2024to 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
- Age 18-75 years old; Histologically or cytologically confirmed as limited-stage small cell lung cancer (T1-3N0-1M0); All lesions of the patient (including primary lesions, lymph nodes/metastatic lesions assessed as metastases) must be jointly evaluated by surgeons, radiotherapists, and radiologists to be surgically resectable; Subjects must have measurable target lesions (according to RECIST 1.1 standards); ECOG performance status score 0-1; No history of other malignant tumors; No previous anti-tumor treatment such as surgery, radiotherapy, chemotherapy, immunotherapy, etc. related to small cell lung cancer; Patients must have sufficient cardiopulmonary function: FEV1 and DLCO of patients are ≥50% of the predicted value, echocardiography indicates LVEF ≥55%, and no clear signs of heart failure, severe coronary artery stenosis, etc. are found in various tests. Cardiopulmonary function is assessed by surgeons to be able to tolerate surgical treatment;
- The functional level of each important organ must meet the following requirements:
- Bone marrow: absolute neutrophil count (ANC) ≥1.5× 109/L, platelets ≥100 × 109/L, hemoglobin ≥9 g/dl;
- Good coagulation function: defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;
- Liver: total bilirubin ≤1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal;
- Kidney: serum creatinine ≤1.25 times the upper limit of normal or creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 ml/min; Men of childbearing potential and women of childbearing age must agree to take effective contraceptive measures from the signing of the main informed consent until 180 days after the last dose of the study drug. Women of childbearing age include premenopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test result within ≤ 7 days before the first administration of the study drug; Voluntarily participate in the clinical study; fully understand and be informed of this study and sign the ICF (Informed Consent Form).
Who cannot join
- All lesions cannot be completely removed by surgery. Received anti-tumor treatment for SCLC (including but not limited to chemotherapy, radiotherapy of the lesion site); Previously used immune checkpoint inhibitors such as PD-1/PD-L1 inhibitors; Any active autoimmune disease or history of autoimmune disease (such as uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy), tuberculosis); Patients with complete remission of childhood asthma and no need for any intervention as an adult or vitiligo can be included, but patients who require bronchodilators for medical intervention are not included; Suffering from congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method) or co-infection with hepatitis B and hepatitis C; Presence of difficult-to-control third-cavity effusion, such as large pleural effusion or ascites or pericardial effusion; Presence of huge mediastinal masses, multiple lesions, extracapsular invasion or fusion of complex small cell lung cancer; Subjects who need systemic treatment with corticosteroids (>10 mg/day of prednisone or equivalent) or other immunosuppressants within 14 days before the first medication. In the absence of active autoimmune diseases, inhaled or topical corticosteroids and adrenal hormone replacement therapy with a dose of >10 mg/day of prednisone at an effective dose are allowed; Subjects who have been treated with anti-tumor vaccines or other anti-tumor drugs with immunostimulatory effects (interferon, interleukin, thymosin, immune cell therapy, etc.) within 1 month before the first medication; Subjects who are participating in other clinical studies or whose first medication time is less than 4 weeks (or 5 half-lives of the study drug) from the end of the previous clinical study (last dose); Evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia, and severe lung function impairment, etc.; Combined with severe heart disease Patients with congestive heart failure of grade III or above (NYHA standard), or angina of grade III or above (CCS standard), or a history of myocardial infarction within 6 months before the start of treatment, or arrhythmia requiring drug treatment; Major surgery, open biopsy or significant trauma within 28 days before enrollment; A known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; Pregnant or lactating women; patients of childbearing potential who are unwilling or unable to take effective contraceptive measures; Known to have allergic reactions, hypersensitivity reactions or intolerance to study drugs Other conditions that the investigator believes are not suitable for 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.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000
Jinshi Liu, MD, 86+13958067757, Liujs@zjcc.org.cn
Jinshi Liu, MD
About this study
Official title: A Single-arm, Prospective, Exploratory Study of Adebrelimab Combined With Chemotherapy and Concurrent SBRT for Neoadjuvant Treatment of Limited-stage Small Cell Lung Cancer and Analysis of Biological Markers(ASSESS)
To explore the effectiveness and safety of adebrelimab combined with chemotherapy and concurrent SBRT for 3 cycles of neoadjuvant treatment followed by surgery in T1-3N0-1M0 limited-stage SCLC
Read the detailed description
This study plans to enroll 20 patients with resectable limited-stage small cell lung cancer in stage T1-3N0-1M0 who have not been treated before. They will receive 3 cycles of adebelimumab combined with chemotherapy and concurrent SBRT. Surgery will be performed within 4-6 weeks after treatment. After surgery, adjuvant therapy will be considered based on the results of MDT discussion. All patients with tumor recurrence and metastasis will enter survival follow-up. Pathological complete response rate (pCR) and safety indexes were used as the main observation indicators.
- Being tested
- adebrelimab and chemotherapy
- Keywords
- small cell lung cancer, Neoadjuvant immunotherapy, SBRT
- 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 and chemotherapyDrug
Also called SBRT
3 cycles of adebrelimab combined with chemotherapy and concurrent SBRT, and undergo surgery within 4-6 weeks after treatment.
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant anti-PDL-1 Immunotherapy combined chemotherapy and SBRT | Experimental | Three cycles of neoadjuvant PDL-1 combined chemotherapy and SBRT followed by surgery for limited-stage small cell lung cancer Receives: Drug: adebrelimab and chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
Pathological Complete Response
Measured: Assessed average of 1 month after surgery
Safety and Tolerability
Adverse reactions (according to CTCAE v5 classification)
Measured: Assessed average of 1 month after surgery
Secondary outcomes (5)
MPR
Major Pathological response
Measured: Assessed average of 1 month after surgery
Event-Free Survival(EFS)
Refers to the time from randomization to the first occurrence of any of the following events: disease progression that is inoperable, local or distant recurrence, death due to any cause, etc.
Measured: From the time of enrollment, until the disease relapses or metastasizes,assessed up to 5 years follow-up.
Objective Response Rate(ORR)
The proportion of patients whose tumors shrink to a certain amount and remain shrinking for a certain period of time includes complete remission (CR) and partial remission (PR).
Measured: From the time of enrollment, assessed before surgery
Overall survival(OS)
The time from the start of treatment to the death of the subject due to various causes was calculated based on the intention-to-treat population (ITT).
Measured: From the time of enrollment, assessed up to 5 years follow-up.
Exploration of tumor efficacy markers
Correlation between MRD biomarkers in tumor tissue and peripheral blood and patients' clinical outcomes, progression, and efficacy.
Measured: From the time of enrollment, assessed up to 5 years follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start24 Jul 2024
- Primary completion31 Jul 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.
- Other trials for Efficacy and Safety of Neoadjuvant Immunotherapy for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe 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
- This study plans to enroll 20 patients with previously untreated T1-3N0-1M0 resectable limited-stage small cell lung cancer. They will receive 3 cycles of adebrelimab combined with chemotherapy and concurrent SBRT, and undergo surgery within 4-6 weeks after treatment. After surgery, adjuvant therapy will be considered based on the results of MDT discussion.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, liujinshi, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562920
- Sponsor's protocol ID
- IRB-2024-738 (IIT)
- Acronym
- Neoadjuvant
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- 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 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Prospective, Exploratory Study of Adebrelimab Combined With Chemotherapy and Concurrent SBRT for Neoadjuvant Treatment of Limited-stage Small Cell Lung Cancer and Analysis of Biological Markers(ASSESS)
- ClinicalTrials.gov ID
- NCT06562920
- Acronym / sponsor ID
- Neoadjuvant / IRB-2024-738 (IIT)
- Keywords
- small cell lung cancer, Neoadjuvant immunotherapy, SBRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 20 Aug 2024 (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.
To explore the effectiveness and safety of adebrelimab combined with chemotherapy and concurrent SBRT for 3 cycles of neoadjuvant treatment followed by surgery in T1-3N0-1M0 limited-stage SCLC
Detailed description
This study plans to enroll 20 patients with resectable limited-stage small cell lung cancer in stage T1-3N0-1M0 who have not been treated before. They will receive 3 cycles of adebelimumab combined with chemotherapy and concurrent SBRT. Surgery will be performed within 4-6 weeks after treatment. After surgery, adjuvant therapy will be considered based on the results of MDT discussion. All patients with tumor recurrence and metastasis will enter survival follow-up. Pathological complete response rate (pCR) and safety indexes were used as the main observation indicators.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study plans to enroll 20 patients with previously untreated T1-3N0-1M0 resectable limited-stage small cell lung cancer. They will receive 3 cycles of adebrelimab combined with chemotherapy and concurrent SBRT, and undergo surgery within 4-6 weeks after treatment. After surgery, adjuvant therapy will be considered based on the results of MDT discussion.
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant anti-PDL-1 Immunotherapy combined chemotherapy and SBRT | Experimental | Drug: adebrelimab and chemotherapyThree cycles of neoadjuvant PDL-1 combined chemotherapy and SBRT followed by surgery for 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
Key inclusion criteria (6 listed)
- Age 18-75 years old; Histologically or cytologically confirmed as limited-stage small cell lung cancer (T1-3N0-1M0); All lesions of the patient (including primary lesions, lymph nodes/metastatic lesions assessed as metastases) must be jointly evaluated by surgeons, radiotherapists, and radiologists to be surgically resectable; Subjects must have measurable target lesions (according to RECIST 1.1 standards); ECOG performance status score 0-1; No history of other malignant tumors; No previous anti-tumor treatment such as surgery, radiotherapy, chemotherapy, immunotherapy, etc. related to small cell lung cancer; Patients must have sufficient cardiopulmonary function: FEV1 and DLCO of patients are ≥50% of the predicted value, echocardiography indicates LVEF ≥55%, and no clear signs of heart failure, severe coronary artery stenosis, etc. are found in various tests. Cardiopulmonary function is assessed by surgeons to be able to tolerate surgical treatment;
- Bone marrow: absolute neutrophil count (ANC) ≥1.5× 109/L, platelets ≥100 × 109/L, hemoglobin ≥9 g/dl;
- Good coagulation function: defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;
- Liver: total bilirubin ≤1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal;
- Kidney: serum creatinine ≤1.25 times the upper limit of normal or creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 ml/min; Men of childbearing potential and women of childbearing age must agree to take effective contraceptive measures from the signing of the main informed consent until 180 days after the last dose of the study drug. Women of childbearing age include premenopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test result within ≤ 7 days before the first administration of the study drug; Voluntarily participate in the clinical study; fully understand and be informed of this study and sign the ICF (Informed Consent Form).
Key exclusion criteria (1 listed)
- All lesions cannot be completely removed by surgery. Received anti-tumor treatment for SCLC (including but not limited to chemotherapy, radiotherapy of the lesion site); Previously used immune checkpoint inhibitors such as PD-1/PD-L1 inhibitors; Any active autoimmune disease or history of autoimmune disease (such as uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy), tuberculosis); Patients with complete remission of childhood asthma and no need for any intervention as an adult or vitiligo can be included, but patients who require bronchodilators for medical intervention are not included; Suffering from congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method) or co-infection with hepatitis B and hepatitis C; Presence of difficult-to-control third-cavity effusion, such as large pleural effusion or ascites or pericardial effusion; Presence of huge mediastinal masses, multiple lesions, extracapsular invasion or fusion of complex small cell lung cancer; Subjects who need systemic treatment with corticosteroids (>10 mg/day of prednisone or equivalent) or other immunosuppressants within 14 days before the first medication. In the absence of active autoimmune diseases, inhaled or topical corticosteroids and adrenal hormone replacement therapy with a dose of >10 mg/day of prednisone at an effective dose are allowed; Subjects who have been treated with anti-tumor vaccines or other anti-tumor drugs with immunostimulatory effects (interferon, interleukin, thymosin, immune cell therapy, etc.) within 1 month before the first medication; Subjects who are participating in other clinical studies or whose first medication time is less than 4 weeks (or 5 half-lives of the study drug) from the end of the previous clinical study (last dose); Evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia, and severe lung function impairment, etc.; Combined with severe heart disease Patients with congestive heart failure of grade III or above (NYHA standard), or angina of grade III or above (CCS standard), or a history of myocardial infarction within 6 months before the start of treatment, or arrhythmia requiring drug treatment; Major surgery, open biopsy or significant trauma within 28 days before enrollment; A known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; Pregnant or lactating women; patients of childbearing potential who are unwilling or unable to take effective contraceptive measures; Known to have allergic reactions, hypersensitivity reactions or intolerance to study drugs Other conditions that the investigator believes are not suitable for participation in the study.
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 and chemotherapyAlso: SBRT3 cycles of adebrelimab combined with chemotherapy and concurrent SBRT, and undergo surgery within 4-6 weeks after treatment. | Drug | neoadjuvant anti-PDL-1 Immunotherapy combined chemotherapy and SBRT |
Primary outcome
pCR
Time frame: Assessed average of 1 month after surgery
Pathological Complete Response
Safety and Tolerability
Time frame: Assessed average of 1 month after surgery
Adverse reactions (according to CTCAE v5 classification)
5 secondary outcomes
MPR
Time frame: Assessed average of 1 month after surgery
Event-Free Survival(EFS)
Time frame: From the time of enrollment, until the disease relapses or metastasizes,assessed up to 5 years follow-up.
Objective Response Rate(ORR)
Time frame: From the time of enrollment, assessed before surgery
Overall survival(OS)
Time frame: From the time of enrollment, assessed up to 5 years follow-up.
Exploration of tumor efficacy markers
Time frame: From the time of enrollment, assessed up to 5 years follow-up.
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 Aug 2024.
- 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 adebrelimab and chemotherapy in people with Efficacy and Safety of Neoadjuvant Immunotherapy for Small Cell Lung Cancer, run by Zhejiang 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 6 inclusion and 1 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 20 Aug 2024. 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 jinshi liu (057188122233, liujs@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR (time frame: Assessed average of 1 month after surgery). The study lists 2 primary outcomes in all. 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 Aug 2024.