Small Cell Lung CancerNCT06480864
Adebrelimab Plus Apatinib for Maintenance Therapy of Extensive Stage Small Cell Lung Cancer
A study testing Adebrelimab Injection, Apatinib Mesylate Tablets and Carboplatin in people with Small Cell Lung Cancer, run by Yunpeng Liu at 2 sites in China.
Trial summary
To evaluate the efficacy and safety of maintenance therapy with Adebrelimab plus Apatinib for extensive stage small cell lung cancer after first-line induction of Adebrelimab plus chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Adebrelimab Injection, Apatinib Mesylate Tablets and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesChina
- Study dates
- 9 Aug 2024to Aug 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants voluntarily enrolled in this study and signed an informed consent form, were compliant and co-operated with follow-up visits;
- Age 18 years and above, male and female;
- Diagnosis of extensive stage small cell lung cancer (ES-SCLC) confirmed by histology or pathology (according to the American Veterans Lung Cancer Association, VALG stage);
- ECOG physical condition score is 0-2;
- Subjects have not received systematic treatment for ES-SCLC in the past (including chemotherapy, VEGFR inhibitors and immune checkpoint inhibitors, etc.)
- Patients with limited stage small cell lung cancer (LS-SCLC) who have received radiotherapy, chemotherapy or radiochemotherapy require a treatment-free period of more than 6 months. Patients with asymptomatic brain metastases are allowed to have cranial radiotherapy during induction chemotherapy;
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- Life expectancy >= 3 months;
- There must be a measurable target lesion that meets the RECIST 1.1 criteria (CT scan length of the tumour lesion >10mm);
- The function of major organs is normal, that is, the following criteria are met.
- Blood routine (not transfused, not using haematopoietic factors and not corrected with drugs within 14 days): ANC ≥ 1.5 x 109/L; HB ≥ 90 g/L; PLT ≥ 100 × 109/L;
- Biochemical tests:
- TBIL ≤ 1.5ULN; TBIL ≤ 1.5 ULN; ALT, AST ≤ 2.5 ULN;
- Renal function: Serum creatinine (Cr) ≤ 1.5 x ULN or creatinine clearance ≥ 40 mL/min. (apply the standard Cockcroft-Gault formula):
- Coagulation function must meet: INR ≤ 1.5 and APTT ≤ 1.5 ULN;
- Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the first dose. Female subjects of childbearing potential and male subjects whose partner is a female of childbearing potential must agree to use a highly effective method of contraception and breastfeeding for the duration of the study up to 90 days after the last administration of study drug. The Investigator or his/her designee, in consultation with the subject, will be required to confirm that the subject has knowledge of how to properly and consistently use the contraceptive method;
- For males, surgical sterilisation or agreement to use a highly effective method of contraception for the duration of the trial and for 90 days after the final administration of study drug;
- For female participants, agreement to refrain from breastfeeding for the duration of the study or for 180 days after the last dose of study treatment is required.
Who cannot join
- Patients with meningeal metastases;
- Prior treatment with any T-cell co-stimulation or immune checkpoint therapy, including, but not limited to, cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, CD137 agonists, or other agents that target T cells;
- Prior treatment with apatinib;
- Factors affecting oral administration of medications such as inability to swallow, post gastrointestinal resection, chronic diarrhoea, intestinal obstruction;
- Any active autoimmune disease or history of autoimmune disease (e.g., uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (may be included after hormone replacement therapy), tuberculosis); and skin disorders (e.g., vitiligo, psoriasis, or alopecia) in which asthma has been in complete remission in childhood and has required no intervention in adulthood or in which systemic therapy is not required. or alopecia areata) may be included; patients requiring medical intervention with bronchodilators may not be included;
- Patients with congenital or acquired immune function defects such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive with HCV-RNA above the lower limit of detection of the analytical method), or co-infection with both hepatitis B and hepatitis C;
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- Urine routine suggesting urinary protein ≥ (++), or 24h urine protein amount ≥ 1g or severe hepatic or renal insufficiency;
- Subjects requiring systemic therapy with corticosteroids (>10 mg/day of prednisone or equivalent) or other immunosuppressive agents within 14 days prior to first dose. Inhaled or topical corticosteroids and adrenal hormone replacement therapy at doses > 10 mg/day prednisone efficacy dose are permitted in the absence of active autoimmune disease;
- Subjects who have been treated with antitumour vaccines or other antitumour agents with immunostimulatory effects (interferon, interleukin, thymidine, immune cell therapy, etc.) within 1 month prior to the first dose;
- Concomitant other malignancies ≤5 years prior to enrolment, except adequately treatable carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer, localised prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery;
- Evidence of previous or current pulmonary fibrosis, interstitial pneumonitis, pneumoconiosis, radiographic pneumonia, drug-induced pneumonia, active pneumonia confirmed by imaging, and severely impaired lung function;
- Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg despite optimal pharmacological treatment);
- Myocardial ischaemia or myocardial infarction of class II or greater, poorly controlled arrhythmias (including QTc intervals ≥450 ms in men and ≥470 ms in women). Myocardial infarction, New York Heart Association class II or higher heart failure, uncontrolled angina pectoris, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or electrocardiogram suggestive of acute ischaemia or active pericardial disease, within 6 months prior to enrolment, according to NYHA criteria, class III-IV cardiac insufficiency or cardiac ultrasound suggestive of a left ventricular ejection fraction (LVEF) of < 50% conduction system abnormalities;
- Complicated severe infection within 4 weeks prior to first dose or unexplained fever >38.5°C during screening/prior to first dose;
- Major surgery, open biopsy or significant trauma within 28 days prior to enrolment;
- An arterial/venous thrombotic event within 6 months;
- A significant risk of coughing up blood, bleeding events, or perforation as assessed by the investigator;
- Known history of allogeneic organ transplantation or allogeneic haematopoietic stem cell transplantation;
- Pregnant or lactating women; patients of childbearing potential who are unwilling or unable to use effective contraception;
- Known hypersensitivity, hypersensitivity or intolerance to adebelizumab, apatinib, chemotherapeutic agents or their excipients;
- Any condition which, in the opinion of the Investigator, may be detrimental to the subject or result in the subject's inability to meet or perform the requirements of the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110002
Lingyun Zhang, +86 15909881516, zhangly1105@126.com
- Not yet recruiting
The First Hospital of China Medical University
Shenyang, 110000
Xiujuan Qu, +86 13604031355
About this study
Official title: Adebrelimab Plus Apatinib for Maintenance Treatment of Extensive Stage Small Cell Lung Cancer After First-line Induction with Adebrelimab Plus Chemotherapy (CLOG2402-ADAPT): a Multi-center, Single-arm, Phase 2 Clinical Trial
To evaluate the efficacy and safety of maintenance therapy with Adebrelimab plus Apatinib for extensive stage small cell lung cancer after first-line induction of Adebrelimab plus chemotherapy.
Read the detailed description
This is a prospective, single-arm trial. To evaluate the efficacy and safety of maintenance therapy with Adebrelimab plus Apatinib for extensive stage small cell lung cancer after first-line induction of Adebrelimab plus chemotherapy.
Induction Period: Participants received adebrelimab (1200 mg, iv., Day1) + carboplatin (AUC 4-5 mg/mL/min)/cisplatin (75 mg/m2) + etoposide (100 mg/m2, D1-3) for 4-6 cycles of three weeks.
Maintenance phase: Participants received adebrelimab (1200mg, iv., Day1) + apatinib (250mg, po., daily) once every three weeks.
Follow-up: After disease progression, at the discretion of the investigator, apatinib and adebrelimab can be used across lines:
For platinum-sensitive patients (≥3 months from last chemotherapy): apatinib and adebrelimab plus platinum-containing two-agent chemotherapy (irinotecan/purple shirts in combination with platinum); for patients with PFS1 >12 months: chemotherapy can be continued with the original EC/EP regimen; For platinum-resistant patients (<3 months from last chemotherapy): apatinib and adebrelimab plus concurrent single-agent chemotherapy (irinotecan or single-agent purple shirts). The dose of chemotherapy agents was adjusted empirically by the investigators.
The primary endpoint is progression-free survival (PFS). Secondary endpoints include objective remission rate (ORR), disease control rate (DCR), duration of remission (DoR), and overall survival (OS); PFS2 (defined as time from enrolment to second disease progression or death) Our study will also explore biomarkers including: haematopoietic factors (IL-6,IL-8, IL-10, etc.), PD-L1 expression, T-cell subsets, T-cell immunoprecision typing and regulatory T-cell counts. The data from our study will provide the basis for further prospective clinical trials (Phase III).
- Conditions
- Small Cell Lung Cancer
- Being tested
- Adebrelimab Injection, Apatinib Mesylate Tablets, Carboplatin, Cisplatin, Etoposide
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab InjectionDrug
Adebrelimab injection (1200mg) will be administered by intravenous infusion during the induction phase and maintenance phase on day 1 in a 3-week treatment cycle.
Apatinib Mesylate TabletsDrug
Apatinib mesylate tablets (250 mg) will be administered orally in a 3-week treatment cycle, once a day.
CarboplatinDrug
Carboplatin (AUC 4-5mg/mL/min) intravenous infusion will be administered during the induction phase on day 1 in a 3-week treatment cycle.
CisplatinDrug
Cisplatin (75mg/m2) intravenous infusion will be administered during the induction phase on day 1 in a 3-week treatment cycle.
EtoposideDrug
Etoposide(100mg/m2) intravenous infusion will be administered during the induction phase from day 1 to 3 in a 3-week treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Adebrelimab+Chemotherapy→Adebrelimab+ Apatinib | Experimental | Participants will receive adebrelimab plus carboplatin /cisplatin and etoposide during the induction phase (4-6 cycles of three weeks.). Thereafter, participants will receive maintenance (after induction phase) adebrelimab plus apatinib until persistent PD, intolerable toxicity or withdrawal of consent. Receives: Drug: Adebrelimab Injection; Drug: Apatinib Mesylate Tablets; Drug: Carboplatin; Drug: Cisplatin; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
To evaluate the efficacy of anti-tumor by Resist1.1 (In months)
Measured: baseline up to approximately 6 month
Secondary outcomes (6)
Objective response rate (ORR)
To evaluate the efficacy of anti-tumor by Resist1.1 (In percent)
Measured: baseline up to approximately 6 month
Disease control rate (DCR)
To evaluate the efficacy of anti-tumor by Resist1.1(In percent)
Measured: baseline up to approximately 6 month
Duration of Response (DOR)
To evaluate the efficacy of anti-tumor by Resist1.1(In months)
Measured: baseline up to approximately 12 months
Overall survival (OS)
To evaluate the efficacy of anti-tumor by Resist1.1(In months)
Measured: baseline up to approximately 12 month
Second progression-free survival (PFS2)
To evaluate the efficacy of anti-tumor by Resist1.1(In months)
Measured: baseline up to approximately 12 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
To identify the incidence of AE and SAE in clinical trial
Measured: From the initiation of the first dose to 28 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start9 Aug 2024
- Primary completionAug 2025 (estimated)
- Study completionAug 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 CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunpeng Liu
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Sponsor-investigator, Yunpeng Liu, China Medical University, China
- Investigators
- Xiujuan Qu, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480864
- Sponsor's protocol ID
- SHR-1316-SCLC-LN-001
- Status last verified
- Dec 2024
- First submitted
- 20 Jun 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adebrelimab Plus Apatinib for Maintenance Treatment of Extensive Stage Small Cell Lung Cancer After First-line Induction with Adebrelimab Plus Chemotherapy (CLOG2402-ADAPT): a Multi-center, Single-arm, Phase 2 Clinical Trial
- ClinicalTrials.gov ID
- NCT06480864
- Acronym / sponsor ID
- SHR-1316-SCLC-LN-001
- Conditions
- Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Yunpeng LiuUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 9 Aug 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 28 Jun 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 evaluate the efficacy and safety of maintenance therapy with Adebrelimab plus Apatinib for extensive stage small cell lung cancer after first-line induction of Adebrelimab plus chemotherapy.
Detailed description
This is a prospective, single-arm trial. To evaluate the efficacy and safety of maintenance therapy with Adebrelimab plus Apatinib for extensive stage small cell lung cancer after first-line induction of Adebrelimab plus chemotherapy.
Induction Period: Participants received adebrelimab (1200 mg, iv., Day1) + carboplatin (AUC 4-5 mg/mL/min)/cisplatin (75 mg/m2) + etoposide (100 mg/m2, D1-3) for 4-6 cycles of three weeks.
Maintenance phase: Participants received adebrelimab (1200mg, iv., Day1) + apatinib (250mg, po., daily) once every three weeks.
Follow-up: After disease progression, at the discretion of the investigator, apatinib and adebrelimab can be used across lines:
For platinum-sensitive patients (≥3 months from last chemotherapy): apatinib and adebrelimab plus platinum-containing two-agent chemotherapy (irinotecan/purple shirts in combination with platinum); for patients with PFS1 >12 months: chemotherapy can be continued with the original EC/EP regimen; For platinum-resistant patients (<3 months from last chemotherapy): apatinib and adebrelimab plus concurrent single-agent chemotherapy (irinotecan or single-agent purple shirts). The dose of chemotherapy agents was adjusted empirically by the investigators.
The primary endpoint is progression-free survival (PFS). Secondary endpoints include objective remission rate (ORR), disease control rate (DCR), duration of remission (DoR), and overall survival (OS); PFS2 (defined as time from enrolment to second disease progression or death) Our study will also explore biomarkers including: haematopoietic factors (IL-6,IL-8, IL-10, etc.), PD-L1 expression, T-cell subsets, T-cell immunoprecision typing and regulatory T-cell counts. The data from our study will provide the basis for further prospective clinical trials (Phase III).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adebrelimab+Chemotherapy→Adebrelimab+ Apatinib | Experimental | Drug: Adebrelimab Injection, Drug: Apatinib Mesylate Tablets, Drug: Carboplatin, Drug: Cisplatin, Drug: EtoposideParticipants will receive adebrelimab plus carboplatin /cisplatin and etoposide during the induction phase (4-6 cycles of three weeks.). Thereafter, participants will receive maintenance (after induction phase) adebrelimab plus apatinib until persistent PD, intolerable toxicity or withdrawal of consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Participants voluntarily enrolled in this study and signed an informed consent form, were compliant and co-operated with follow-up visits;
- Age 18 years and above, male and female;
- Diagnosis of extensive stage small cell lung cancer (ES-SCLC) confirmed by histology or pathology (according to the American Veterans Lung Cancer Association, VALG stage);
- ECOG physical condition score is 0-2;
- Subjects have not received systematic treatment for ES-SCLC in the past (including chemotherapy, VEGFR inhibitors and immune checkpoint inhibitors, etc.)
Key exclusion criteria (21 listed)
- Patients with meningeal metastases;
- Prior treatment with any T-cell co-stimulation or immune checkpoint therapy, including, but not limited to, cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, CD137 agonists, or other agents that target T cells;
- Prior treatment with apatinib;
- Factors affecting oral administration of medications such as inability to swallow, post gastrointestinal resection, chronic diarrhoea, intestinal obstruction;
- Any active autoimmune disease or history of autoimmune disease (e.g., uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (may be included after hormone replacement therapy), tuberculosis); and skin disorders (e.g., vitiligo, psoriasis, or alopecia) in which asthma has been in complete remission in childhood and has required no intervention in adulthood or in which systemic therapy is not required. or alopecia areata) may be included; patients requiring medical intervention with bronchodilators may not be included;
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 InjectionAdebrelimab injection (1200mg) will be administered by intravenous infusion during the induction phase and maintenance phase on day 1 in a 3-week treatment cycle. | Drug | Adebrelimab+Chemotherapy→Adebrelimab+ Apatinib |
| Apatinib Mesylate TabletsApatinib mesylate tablets (250 mg) will be administered orally in a 3-week treatment cycle, once a day. | Drug | Adebrelimab+Chemotherapy→Adebrelimab+ Apatinib |
| CarboplatinCarboplatin (AUC 4-5mg/mL/min) intravenous infusion will be administered during the induction phase on day 1 in a 3-week treatment cycle. | Drug | Adebrelimab+Chemotherapy→Adebrelimab+ Apatinib |
| CisplatinCisplatin (75mg/m2) intravenous infusion will be administered during the induction phase on day 1 in a 3-week treatment cycle. | Drug | Adebrelimab+Chemotherapy→Adebrelimab+ Apatinib |
| EtoposideEtoposide(100mg/m2) intravenous infusion will be administered during the induction phase from day 1 to 3 in a 3-week treatment cycle. | Drug | Adebrelimab+Chemotherapy→Adebrelimab+ Apatinib |
Primary outcome
Progression-free survival (PFS)
Time frame: baseline up to approximately 6 month
To evaluate the efficacy of anti-tumor by Resist1.1 (In months)
6 secondary outcomes
Objective response rate (ORR)
Time frame: baseline up to approximately 6 month
Disease control rate (DCR)
Time frame: baseline up to approximately 6 month
Duration of Response (DOR)
Time frame: baseline up to approximately 12 months
Overall survival (OS)
Time frame: baseline up to approximately 12 month
Second progression-free survival (PFS2)
Time frame: baseline up to approximately 12 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From the initiation of the first dose to 28 days after the last dose
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 6 Jan 2025.
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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.
Xiujuan Qu principal investigator
First Hospital of China Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adebrelimab Injection, Apatinib Mesylate Tablets and Carboplatin in people with Small Cell Lung Cancer, run by Yunpeng Liu at 2 sites 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 17 inclusion and 21 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 6 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 2 sites 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 Xiujuan Qu (13604031355, cmu1h_zlnk_trial@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 (PFS) (time frame: baseline up to approximately 6 month). 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 6 Jan 2025.