Small Cell Lung Cancer (SCLC)Phase 2NCT06485544
Neoadjuvant Adebrelimab in Resectable SCLC: A Randomized Trial
A Phase 2 study testing Adebrelimab + Etoposide + Platinum-based Therapy and Etoposide + Platinum-based Therapy in people with Small Cell Lung Cancer (SCLC), run by Tang-Du Hospital at 1 site in China.
Trial summary
This study is a randomized, open-label, multicenter exploratory research aiming to evaluate the efficacy and safety of Adebrelimab in combination with chemotherapy (etoposide and platinum-based therapy) as neoadjuvant treatment for resectable stage I-IIIB (stage IIIB limited to T1-4N1-2M0) small cell lung cancer… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer (SCLC)
- What is being tested?
- Adebrelimab + Etoposide + Platinum-based Therapy and Etoposide + Platinum-based Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 30 Dec 2026
- 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 between 18 and 75 years, inclusive, with no restriction on gender.
- ECOG performance status of 0-1.
- Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC).
- According to the 8th edition of AJCC staging, participants must have resectable or potentially resectable stage I-IIIB (T1-4N0-2M0) SCLC.
- Measurable lesions (tumor lesions with a CT scan long axis ≥10 mm, lymph node lesions with a CT scan short axis ≥10 mm).
- Initial diagnosis of small cell lung cancer without prior treatment with radiation, chemotherapy, traditional Chinese medicine, surgery, or targeted therapy.
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- Various imaging examinations including PET-CT, enhanced CT or ultrasound of the chest and abdomen, MRI of the head, and bone scan confirm no metastatic lesions.
- Participants must have sufficient cardiopulmonary function to tolerate planned lung resection surgery.
- No contraindications to immune checkpoint inhibitor (ICI) use based on laboratory tests.
- Normal organ function, as defined by the following criteria:
- Hematological criteria (within 14 days without blood transfusion, hematopoietic factors, or correcting medications):
- ANC ≥ 1.5 × 10^9/L;
- PLT ≥ 100 × 10^9/L;
- Hb ≥ 90 g/L; (2) Biochemical criteria:
- TBIL ≤ 1.5 × ULN; b. ALT, AST ≤ 2.5 × ULN (if abnormal liver function due to liver metastasis, ≤ 5 × ULN); c. Serum creatinine (sCr) ≤ 1.5 × ULN, estimated glomerular filtration rate (eGFR) ≥ 50 mL/min (Cockcroft-Gault formula); (3) Coagulation function: INR ≤ 1.5 × ULN and APTT ≤ 1.5 × ULN. 11. Female participants of childbearing potential must have a negative serum pregnancy test within 3 days before starting study medication and agree to use a medically accepted method of highly effective contraception during the study and for 3 months after the last dose of study drug (e.g., intrauterine device, contraceptive pills, or condoms). Male participants with female partners of childbearing potential must have undergone surgical sterilization or agree to use effective contraception during the study and for 3 months after the last dose of study drug.
- 12. Participants must voluntarily consent to participate in this study, sign an informed consent form, demonstrate good compliance, and agree to follow-up visits.
Who cannot join
- Central nervous system metastasis.
- History of any active autoimmune disease or autoimmune disease (including but not limited to moderate or severe interstitial lung disease, uveitis, colitis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism [patients controlled by hormone replacement therapy may be included]); patients with vitiligo or childhood asthma completely resolved without adult intervention may be included; patients requiring bronchodilators for medical intervention are excluded.
- Congenital or acquired immunodeficiency, such as HIV infection, active hepatitis B (HBV DNA ≥ 500 IU/mL), hepatitis C (HCV antibody positive with HCV-RNA above the lower limit of detection by analytical methods), or co-infection of hepatitis B and C, active pulmonary tuberculosis.
- Use of immunosuppressive drugs within 14 days prior to the first administration of the study drug, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroid hormones (i.e., no more than 10 mg/day of prednisone or its equivalent).
- Vaccination with live attenuated vaccines within 4 weeks before the first administration or planned during the study period.
- Any other malignancy within the past 3 years.
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- Evidence of past or present pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia, or severely impaired lung function.
- Uncontrolled hypertension.
- Grade II or higher myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QTc interval ≥450 ms for males and ≥470 ms for females). According to NYHA standards, Class III-IV heart failure, or left ventricular ejection fraction (LVEF) < 50% by cardiac ultrasound, myocardial infarction within 6 months before enrollment, NYHA Class II or higher heart failure, uncontrolled angina, uncontrolled severe ventricular arrhythmias, clinically significant pericardial disease, or electrocardiogram (ECG) indicating acute ischemia or active conduction system abnormalities.
- Severe infection within 4 weeks before the first administration (e.g., requiring intravenous antibiotics, antifungals, or antivirals), or unexplained fever > 38.5°C during screening/first administration.
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Pregnant or breastfeeding women; patients of childbearing potential unwilling or unable to use effective contraception.
- Known allergic reaction, hypersensitivity, or intolerance to SHR-1316, etoposide, cisplatin, or their excipients.
- Participation in another clinical study or less than 4 weeks since the end (last dose) of a previous clinical study, or less than 5 half-lives of the study drug.
- Known history of substance abuse, alcohol abuse, or drug addiction.
- Any condition that the investigator believes may compromise the safety of the participant or the participant's ability to meet or follow study requirements.
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
Tangdu Hospital Affiliated to the Fourth Military Medical University
Xi'an, Shannxi, 710038
Xiaolong Yan, Dr, 029-847171569, yanxiaolong@fmmu.edu.cn
About this study
Official title: A Multicenter Randomized Controlled Trial of Neoadjuvant Adebrelimab Combined With Chemotherapy for Resectable Small Cell Lung Cancer (SCLC)
This study is a randomized, open-label, multicenter exploratory research aiming to evaluate the efficacy and safety of Adebrelimab in combination with chemotherapy (etoposide and platinum-based therapy) as neoadjuvant treatment for resectable stage I-IIIB (stage IIIB limited to T1-4N1-2M0) small cell lung cancer (SCLC). The study is primarily conducted at Tangdu Hospital of the Fourth Military Medical University. A total of 104 patients with stage IA-IIIB SCLC (stage IIIB limited to T1-4N1-2M0) will be enrolled and randomized 1:1 to receive either Adebrelimab plus chemotherapy or chemotherapy alone. Each patient will undergo 3 cycles of study treatment followed by a 3-4 week break before surgery. Treatment will be discontinued if patients experience disease progression, intolerable drug-related adverse events, withdrawal of informed consent, or other specified conditions during the study. Effectiveness and safety outcomes will be monitored throughout the trial. The primary objective is to evaluate pathological complete response (pCR) with Adebrelimab combination therapy. Secondary objectives include assessing event-free survival (EFS), major pathological response (mPR), objective response rate (ORR), disease-free survival (DFS), and safety.
- Conditions
- Small Cell Lung Cancer (SCLC)
- Being tested
- Adebrelimab + Etoposide + Platinum-based Therapy, Etoposide + Platinum-based Therapy
- Keywords
- SCLC, Adebrelimab, Neoadjuvant, Chemotherapy
- 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 + Etoposide + Platinum-based TherapyDrug
Intervention Description for Treatment Group:
This intervention includes Adebrelimab in combination with Etoposide and Platinum-based therapy as neoadjuvant treatment for resectable small cell lung cancer (SCLC). Adebrelimab is administered intravenously at a fixed dose of 1200 mg over 30 minutes on Day 1 of each 3-week cycle, followed by Etoposide at a dose of 100 mg/m2 via intravenous infusion over 30 minutes on Days 1 to 3 of each cycle. Concurrently, Platinum-based therapy (either Cisplatin at AUC5 or Carboplatin at AUC5 or Cisplatin at 100 mg/m2) is administered via intravenous infusion on Day 1 of each cycle. The treatment regimen consists of 3-4 cycles, with a 4-6 week drug-free interval before surgical treatment.
Etoposide + Platinum-based TherapyDrug
Intervention Description for Control Group:
This intervention includes Etoposide in combination with Platinum-based therapy as neoadjuvant treatment for resectable small cell lung cancer (SCLC). Etoposide is administered at a dose of 100 mg/m2 via intravenous infusion over 30 minutes on Days 1 to 3 of each 3-week cycle. Concurrently, Platinum-based therapy (either Cisplatin at AUC5 or Carboplatin at AUC5 or Cisplatin at 100 mg/m2) is administered via intravenous infusion on Day 1 of each cycle. The treatment regimen consists of 3-4 cycles, with a 4-6 week drug-free interval before surgical treatment.
| Study group | Role | What they receive |
|---|---|---|
| Adebrelimab + Etoposide + Platinum-based Therapy | Experimental | Participants in this arm will receive Adebrelimab, Etoposide, and Platinum-based therapy. Adebrelimab will be administered intravenously at a fixed dose of 1200 mg over 30 minutes on Day 1 of each 3-week cycle. Following Adebrelimab, Etoposide will be given at a dose of 100 mg/m2 via intravenous infusion over 30 minutes on Days 1 to 3 of each cycle. Concurrently, Platinum-based therapy (either Cisplatin at AUC5 or Carboplatin at AUC5 or Cisplatin at 100 mg/m2) will be administered via intravenous infusion on Day 1 of each cycle. This treatment regimen will be repeated for 3-4 cycles, with a 4-6 week drug-free interval before surgical treatment. Receives: Drug: Adebrelimab + Etoposide + Platinum-based Therapy |
| Etoposide + Platinum-based Therapy | Active comparator | Participants in this arm will receive Etoposide and Platinum-based therapy. Etoposide will be administered at a dose of 100 mg/m2 via intravenous infusion over 30 minutes on Days 1 to 3 of each 3-week cycle. Concurrently, Platinum-based therapy (either Cisplatin at AUC5 or Carboplatin at AUC5 or Cisplatin at 100 mg/m2) will be administered via intravenous infusion on Day 1 of each cycle. This treatment regimen will be repeated for 3-4 cycles, with a 4-6 week drug-free interval before surgical treatment. Receives: Drug: Etoposide + Platinum-based Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate(pCR)
Pathologic complete response (pCR), defined as the absence of tumor cells in all specimens (ypT0N0) .
Measured: 7 days after surgery.
Secondary outcomes (4)
Event-free survival (EFS)
The length of time after primary treatment for a cancer ends that the patient remains free of certain complicationsor events that the treatment was intended toprevent or delay.
Measured: Long term follow-up will continue until preoperative progression, postoperative recurrence, or death from any cause at least two years.
Major pathologic response (MPR)
MPR is defned as less than 10% residual viable tumor after neoadjuvant therapy.
Measured: 7 days after surgery.
Objective response rate (ORR)
Per Response Evaluation Criteria in Solid Tumorsersion 1.1(REClST 1.1) using Investigator assessments, is defneas the number (%) of patients with responseof Complete Response or Partial Response.
Measured: 7 days before surgery
Disease-free survival(DFS)
The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.
Measured: Long term follow-up will continue until the death of the subiect or the end of the studv. at least two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (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 (SCLC)Studies of the same condition, open and under way.
- More trials run by Tang-Du 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485544
- Sponsor's protocol ID
- IIT202405-04
- Status last verified
- Jul 2024
- First submitted
- 20 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial of Neoadjuvant Adebrelimab Combined With Chemotherapy for Resectable Small Cell Lung Cancer (SCLC)
- ClinicalTrials.gov ID
- NCT06485544
- Acronym / sponsor ID
- IIT202405-04
- Conditions
- Small Cell Lung Cancer (SCLC)
- Keywords
- SCLC, Adebrelimab, Neoadjuvant, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 3 Jul 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.
This study is a randomized, open-label, multicenter exploratory research aiming to evaluate the efficacy and safety of Adebrelimab in combination with chemotherapy (etoposide and platinum-based therapy) as neoadjuvant treatment for resectable stage I-IIIB (stage IIIB limited to T1-4N1-2M0) small cell lung cancer (SCLC). The study is primarily conducted at Tangdu Hospital of the Fourth Military Medical University. A total of 104 patients with stage IA-IIIB SCLC (stage IIIB limited to T1-4N1-2M0) will be enrolled and randomized 1:1 to receive either Adebrelimab plus chemotherapy or chemotherapy alone. Each patient will undergo 3 cycles of study treatment followed by a 3-4 week break before surgery. Treatment will be discontinued if patients experience disease progression, intolerable drug-related adverse events, withdrawal of informed consent, or other specified conditions during the study. Effectiveness and safety outcomes will be monitored throughout the trial. The primary objective is to evaluate pathological complete response (pCR) with Adebrelimab combination therapy. Secondary objectives include assessing event-free survival (EFS), major pathological response (mPR), objective response rate (ORR), disease-free survival (DFS), and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adebrelimab + Etoposide + Platinum-based Therapy | Experimental | Drug: Adebrelimab + Etoposide + Platinum-based TherapyParticipants in this arm will receive Adebrelimab, Etoposide, and Platinum-based therapy. Adebrelimab will be administered intravenously at a fixed dose of 1200 mg over 30 minutes on Day 1 of each 3-week cycle. Following Adebrelimab, Etoposide will be given at a dose of 100 mg/m2 via intravenous infusion over 30 minutes on Days 1 to 3 of each cycle. Concurrently, Platinum-based therapy (either Cisplatin at AUC5 or Carboplatin at AUC5 or Cisplatin at 100 mg/m2) will be administered via intravenous infusion on Day 1 of each cycle. This treatment regimen will be repeated for 3-4 cycles, with a 4-6 week drug-free interval before surgical treatment. |
| Etoposide + Platinum-based Therapy | Active comparator | Drug: Etoposide + Platinum-based TherapyParticipants in this arm will receive Etoposide and Platinum-based therapy. Etoposide will be administered at a dose of 100 mg/m2 via intravenous infusion over 30 minutes on Days 1 to 3 of each 3-week cycle. Concurrently, Platinum-based therapy (either Cisplatin at AUC5 or Carboplatin at AUC5 or Cisplatin at 100 mg/m2) will be administered via intravenous infusion on Day 1 of each cycle. This treatment regimen will be repeated for 3-4 cycles, with a 4-6 week drug-free interval before surgical treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age between 18 and 75 years, inclusive, with no restriction on gender.
- ECOG performance status of 0-1.
- Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC).
- According to the 8th edition of AJCC staging, participants must have resectable or potentially resectable stage I-IIIB (T1-4N0-2M0) SCLC.
- Measurable lesions (tumor lesions with a CT scan long axis ≥10 mm, lymph node lesions with a CT scan short axis ≥10 mm).
Key exclusion criteria (16 listed)
- Central nervous system metastasis.
- History of any active autoimmune disease or autoimmune disease (including but not limited to moderate or severe interstitial lung disease, uveitis, colitis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism [patients controlled by hormone replacement therapy may be included]); patients with vitiligo or childhood asthma completely resolved without adult intervention may be included; patients requiring bronchodilators for medical intervention are excluded.
- Congenital or acquired immunodeficiency, such as HIV infection, active hepatitis B (HBV DNA ≥ 500 IU/mL), hepatitis C (HCV antibody positive with HCV-RNA above the lower limit of detection by analytical methods), or co-infection of hepatitis B and C, active pulmonary tuberculosis.
- Use of immunosuppressive drugs within 14 days prior to the first administration of the study drug, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroid hormones (i.e., no more than 10 mg/day of prednisone or its equivalent).
- Vaccination with live attenuated vaccines within 4 weeks before the first administration 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 + Etoposide + Platinum-based TherapyIntervention Description for Treatment Group: This intervention includes Adebrelimab in combination with Etoposide and Platinum-based therapy as neoadjuvant treatment for resectable small cell lung cancer (SCLC). Adebrelimab is administered intravenously at a fixed dose of 1200 mg over 30 minutes on Day 1 of each 3-week cycle, followed by Etoposide at a dose of 100 mg/m2 via intravenous infusion over 30 minutes on Days 1 to 3 of each cycle. Concurrently, Platinum-based therapy (either Cisplatin at AUC5 or Carboplatin at AUC5 or Cisplatin at 100 mg/m2) is administered via intravenous infusion on Day 1 of each cycle. The treatment regimen consists of 3-4 cycles, with a 4-6 week drug-free interval before surgical treatment. | Drug | Adebrelimab + Etoposide + Platinum-based Therapy |
| Etoposide + Platinum-based TherapyIntervention Description for Control Group: This intervention includes Etoposide in combination with Platinum-based therapy as neoadjuvant treatment for resectable small cell lung cancer (SCLC). Etoposide is administered at a dose of 100 mg/m2 via intravenous infusion over 30 minutes on Days 1 to 3 of each 3-week cycle. Concurrently, Platinum-based therapy (either Cisplatin at AUC5 or Carboplatin at AUC5 or Cisplatin at 100 mg/m2) is administered via intravenous infusion on Day 1 of each cycle. The treatment regimen consists of 3-4 cycles, with a 4-6 week drug-free interval before surgical treatment. | Drug | Etoposide + Platinum-based Therapy |
Primary outcome
Pathological complete response rate(pCR)
Time frame: 7 days after surgery.
Pathologic complete response (pCR), defined as the absence of tumor cells in all specimens (ypT0N0) .
4 secondary outcomes
Event-free survival (EFS)
Time frame: Long term follow-up will continue until preoperative progression, postoperative recurrence, or death from any cause at least two years.
Major pathologic response (MPR)
Time frame: 7 days after surgery.
Objective response rate (ORR)
Time frame: 7 days before surgery
Disease-free survival(DFS)
Time frame: Long term follow-up will continue until the death of the subiect or the end of the studv. at least two 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 3 Jul 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 + Etoposide + Platinum-based Therapy and Etoposide + Platinum-based Therapy in people with Small Cell Lung Cancer (SCLC), run by Tang-Du 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 16 inclusion and 16 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 3 Jul 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 Xiaolong Yan, Dr (029-847171569, yanxiaolong@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate(pCR) (time frame: 7 days after surgery.). 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 3 Jul 2024.