Extensive-Stage Small Cell Lung CancerPhase 2NCT06614621
A Study of Adebelimab Combined With Chemotherapy as a First-line Treatment Sequential Treatment for Extensive-stage Small Cell Lung Cancer
A Phase 2 study testing Adebrelimab +Etoposide+Platinum-based drugs and Maintenance treatment period: in people with Extensive-Stage Small Cell Lung Cancer, run by Fujian Cancer Hospital.
Trial summary
A study of adebelimab in combination with chemotherapy in the first-line treatment of extensive-stage small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extensive-Stage Small Cell Lung Cancer
- What is being tested?
- Adebrelimab +Etoposide+Platinum-based drugs and Maintenance treatment period:
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 1 Dec 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
- Patients with extensive-stage small cell lung cancer confirmed by pathological histology or cytology (excluding composite and small cell lung cancer);
- Age at the time of signing the informed consent: 18-75 years old (including 18 years old and 75 years old), male or female;
- United States Eastern Cooperative Oncology Group (ECOG) score performance status of 0 or 1;
- Have not received prior systemic therapy for extensive-stage small cell lung cancer;
- At least one measurable lesion per RECIST v1.1 criteria;
- Expected survival ≥ 3 months;
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- Normal function of major organs, i.e., meeting the following criteria:
- 1) Routine blood test: hemoglobin (Hb) ≥90g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelets (PLT) ≥ 100×109/L; White blood cell count (WBC) ≥ 3.0×109/L; 2) Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (for patients with tumor liver metastasis, ≤5×ULN); Serum total bilirubin (TBIL) ≤ 1.5× ULN (Gilbert syndrome subjects, ≤3× ULN; In patients with liver metastases, total bilirubin ≤3× ULN); Serum creatinine (Cr) ≤ 1.5× ULN or creatinine clearance ≥ 50ml/min; 3) Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤1.5×ULN; 8. Females of childbearing potential should agree that contraception (such as intrauterine device [IUD], contraceptive pill or condom) must be used during the study and for 6 months after the end of the study; Negative serum pregnancy test within 28 days prior to study enrollment and must be non-lactating subjects; Males should be subjects who agree to use contraception for the duration of the study and for 6 months after the end of the study period.
- 9. Subjects voluntarily joined this study, signed the informed consent form, had good compliance, and cooperated with follow-up
Who cannot join
- 1. Known allergy to any of the drugs in the study; 2. Previous or concurrent other malignant tumors, excluding cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast (DCIS), papillary thyroid carcinoma and other malignant tumors that have been adequately treated and cured for ≥ 5 years before the first dose and have evidence to confirm that there is no recurrence and metastasis; 3. Presence of symptomatic or active central nervous system (CNS) metastases or carcinomatous meningitis (asymptomatic or post-treatment stable brain metastases are allowed); 4. Presence of active or previous autoimmune disease or immunodeficiency; 5. Presence of active or previous autoimmune disease or immunodeficiency Imaging (CT or MRI) shows tumor invasion of or ill-demarcation of large vessels; or judged by the investigator that the subject\'s tumor has a very high probability of invading important blood vessels and causing fatal hemorrhage during treatment; 6. Have hypertension that is not well controlled by antihypertensive medication (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 100 mmHg); 7. Cardiovascular and cerebrovascular diseases with significant clinical significance:
- Cerebrovascular accident (excluding lacunar cerebral infarction, minor cerebral ischemia or transient ischemic attack, etc.), myocardial infarction, unstable angina, poorly controlled arrhythmia (including QTc interval ≥ 450 ms for males and ≥ 470 ms for females) within 6 months before the first dose of the study drug (QTc interval is calculated by Fridericia\'s formula);
- United States New York Heart Association (NYHA) cardiac function class \> class II or left ventricular ejection fraction (LVEF) \<50%; 8. Active or uncontrolled severe infection;
- Known human immunodeficiency virus (HIV) infection;
- History of known clinically significant liver disease, including viral hepatitis [known hepatitis B virus (HBV) carriers must rule out active HBV infection, i.e., HBV DNA positive (\>1×104 copies/mL or \>2000 IU/ml);
- Known hepatitis C virus infection (HCV) and HCV RNA positive (\>1×103 copies/mL), or other hepatitis, cirrhosis; 9. Patients who are judged by the investigator to be accompanied by uncontrollable third space effusions such as pleural effusion, pericardial effusion or peritoneal effusion, which require puncture and drainage; or those who have received ascites and pleural effusion drainage within 14 days before the first dose; 10. Patients with interstitial pneumonia or interstitial lung disease, or a history of interstitial pneumonia or interstitial lung disease requiring hormonal therapy, or other pulmonary fibrosis, chronic pneumonia, pneumonia-induced by drugs or radiotherapy, history of congenital pneumonia, or any evidence of active pneumonia on chest CT scan that may interfere with the judgment of immune-related pulmonary toxicity; Patients with severe impairment of lung function confirmed by current pulmonary function tests; 11. Subjects who need to be treated with systemic corticosteroids (\> 10 mg/day effective dose of prednisone) or other immunosuppressive medications within 14 days prior to the first dose or during the study. However, enrollment is allowed in the following cases: in the absence of active autoimmune disease, subjects are allowed to use topical or inhaled steroids and adrenal hormone replacement therapy at an effective dose of ≤ 10 mg/day prednisone; 12. Subject currently has any current disease or state that affects drug absorption, or subject cannot take apatinib orally; 13. Those whose urine routine shows that urine protein ≥2+, and the 24-hour urine protein quantification \> 1.0g; 14. In the opinion of the investigator, the subject has any clinical or laboratory examination abnormalities or other reasons that make it unsuitable to participate in this clinical study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-arm, Single-center, Prospective Clinical Study of Adebelimab Combined With Chemotherapy for First-line Treatment of Sequential Adebelimab Plus Apatinib Maintenance Therapy in Patients With Extensive-stage Small Cell Lung Cancer
A study of adebelimab in combination with chemotherapy in the first-line treatment of extensive-stage small cell lung cancer
Read the detailed description
This study aims to evaluate the efficacy (PFS, ORR, DCR, OS) and safety of adebelimab in combination with chemotherapy as a first-line treatment for the maintenance treatment of adebelimab plus Apatinib Mesylate Tablets with extensive-stage small cell lung cancer
- Conditions
- Extensive-Stage Small Cell Lung Cancer
- Being tested
- Adebrelimab +Etoposide+Platinum-based drugs, Maintenance treatment period:
- Keywords
- Adebrelimab, Apatinib Mesylate Tablets, 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 +Etoposide+Platinum-based drugsDrug
Adebrelimab:20mg/kg或1200mg ivgtt ,d1 ,Q3W Etoposide injection (E): 100mg/m2, ivgtt, d1,d2,d3,Q3W Platinum-based drugs:75mg/m2, ivgtt, d1,d2,d3,Q3W
Maintenance treatment period:Drug
Adebrelimab:20mg/kg或1200mg,IV, Q3W; Apatinib Mesylate Tablets:250mg,P.O,qod
| Study group | Role | What they receive |
|---|---|---|
| Extensive-stage small cell lung cancer | Experimental | Therapeutic medications Receives: Drug: Adebrelimab +Etoposide+Platinum-based drugs; Drug: Maintenance treatment period: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival(PFS)
First-line treatment with adebelimab plus chemotherapy for sequential adebelimab plus apatinib maintenance therapy for progression-free survival (PFS) in patients with extensive-stage small cell lung cancer
Measured: 12 months
Secondary outcomes (2)
Objective response rate(ORR)
Objective response rate (ORR) of adebelimab plus chemotherapy in first-line treatment of sequential adebelimab plus apatinib maintenance therapy in patients with extensive-stage small cell lung cancer
Measured: 12 months
Disease control rate(DCR)
Disease control rate (DCR) of adebelimab plus chemotherapy in first-line treatment of sequential adebelimab plus apatinib maintenance therapy in patients with extensive-stage small cell lung cancer
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Feb 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Fujian 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
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614621
- Sponsor's protocol ID
- FJ-SCLC-01
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 26 Sep 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 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Single-center, Prospective Clinical Study of Adebelimab Combined With Chemotherapy for First-line Treatment of Sequential Adebelimab Plus Apatinib Maintenance Therapy in Patients With Extensive-stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06614621
- Acronym / sponsor ID
- FJ-SCLC-01
- Conditions
- Extensive-Stage Small Cell Lung Cancer
- Keywords
- Adebrelimab, Apatinib Mesylate Tablets, Etoposide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 26 Sep 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.
A study of adebelimab in combination with chemotherapy in the first-line treatment of extensive-stage small cell lung cancer
Detailed description
This study aims to evaluate the efficacy (PFS, ORR, DCR, OS) and safety of adebelimab in combination with chemotherapy as a first-line treatment for the maintenance treatment of adebelimab plus Apatinib Mesylate Tablets with extensive-stage small cell lung cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extensive-stage small cell lung cancer | Experimental | Drug: Adebrelimab +Etoposide+Platinum-based drugs, Drug: Maintenance treatment period:Therapeutic medications |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with extensive-stage small cell lung cancer confirmed by pathological histology or cytology (excluding composite and small cell lung cancer);
- Age at the time of signing the informed consent: 18-75 years old (including 18 years old and 75 years old), male or female;
- United States Eastern Cooperative Oncology Group (ECOG) score performance status of 0 or 1;
- Have not received prior systemic therapy for extensive-stage small cell lung cancer;
- At least one measurable lesion per RECIST v1.1 criteria;
Key exclusion criteria (6 listed)
- 1. Known allergy to any of the drugs in the study; 2. Previous or concurrent other malignant tumors, excluding cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast (DCIS), papillary thyroid carcinoma and other malignant tumors that have been adequately treated and cured for ≥ 5 years before the first dose and have evidence to confirm that there is no recurrence and metastasis; 3. Presence of symptomatic or active central nervous system (CNS) metastases or carcinomatous meningitis (asymptomatic or post-treatment stable brain metastases are allowed); 4. Presence of active or previous autoimmune disease or immunodeficiency; 5. Presence of active or previous autoimmune disease or immunodeficiency Imaging (CT or MRI) shows tumor invasion of or ill-demarcation of large vessels; or judged by the investigator that the subject\'s tumor has a very high probability of invading important blood vessels and causing fatal hemorrhage during treatment; 6. Have hypertension that is not well controlled by antihypertensive medication (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 100 mmHg); 7. Cardiovascular and cerebrovascular diseases with significant clinical significance:
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 drugsAdebrelimab:20mg/kg或1200mg ivgtt ,d1 ,Q3W Etoposide injection (E): 100mg/m2, ivgtt, d1,d2,d3,Q3W Platinum-based drugs:75mg/m2, ivgtt, d1,d2,d3,Q3W | Drug | Extensive-stage small cell lung cancer |
| Maintenance treatment period:Adebrelimab:20mg/kg或1200mg,IV, Q3W; Apatinib Mesylate Tablets:250mg,P.O,qod | Drug | Extensive-stage small cell lung cancer |
Primary outcome
Progression-free survival(PFS)
Time frame: 12 months
First-line treatment with adebelimab plus chemotherapy for sequential adebelimab plus apatinib maintenance therapy for progression-free survival (PFS) in patients with extensive-stage small cell lung cancer
2 secondary outcomes
Objective response rate(ORR)
Time frame: 12 months
Disease control rate(DCR)
Time frame: 12 months
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 26 Sep 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adebrelimab +Etoposide+Platinum-based drugs and Maintenance treatment period: in people with Extensive-Stage Small Cell Lung Cancer, run by Fujian Cancer Hospital.
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 9 inclusion and 6 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 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Huang Zhang Zhou (13609578088, 1609305255@qq.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: 12 months). 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 26 Sep 2024.