Small Cell Lung Cancer Extensive StagePhase 2NCT06786312
A Single-arm, Multicenter, Prospective Phase II Clinical Study of Apatinib in Combination With Adebrelimab and EC Regimen in the First-line Treatment of Extensive Small Cell Lung Cancer
A Phase 2 study testing Apatinib, Adebrelimab and Etoposide Injection in people with Small Cell Lung Cancer Extensive Stage, run by Fujian Cancer Hospital at 4 sites in China.
Trial summary
To evaluate the efficacy and safety of apatinib combined with adebrelizumab and EC in the first-line treatment of extensive 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 Extensive Stage
- What is being tested?
- Apatinib, Adebrelimab and Etoposide Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 4 sitesChina
- Study dates
- 25 Jan 2025to 25 Sep 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
- 1. Patients with extensive stage small cell lung cancer confirmed by histopathology or cytology (excluding complex small cell lung cancer);
- 2. Age at the time of signing the informed consent: 18-75 years old (including 18 and 75 years old), male or female;
- 3. The physical status of the Eastern Oncology Consortium (ECOG) was 0 or 1 (see Annex 1 for the ECOGPS scoring criteria);
- 4. Have not received systematic treatment for extensive small cell lung cancer;
- 5. Have at least one measurable lesion that meets the RECIST v1.1 standard (see Annex 3);
- 6. Expected survival >=3 months;
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- 7. If the major organs function normally, the following criteria are met:
- Blood routine test: hemoglobin (Hb) >=90g/L; Absolute neutrophil count (ANC) >=1.5×10^9/L; Platelet (PLT) >=100×10^9/L; White blood cell count (WBC) >= 3.0×10^9/L;
- Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5×ULN (tumor liver metastasis, <=5×ULN); Serum total bilirubin (TBIL) <=1.5×ULN (Gilbert syndrome subjects, <=3×ULN; In patients with liver metastasis, total bilirubin <=3× ULN); Serum creatinine (Cr) <=1.5×ULN or creatinine clearance >=50ml/min;
- Coagulation function: activated partial thromboplastin time (APTT), International standardized ratio (INR), prothrombin time (PT) <=1.5×ULN;
- Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF)>=50%;
- 8. BMS must be asymptomatic or treated and stable after discontinuation of steroids and anticonvulsants for at least 1 month prior to study therapy;
- 9. Women of reproductive age should agree that they must use contraceptives (such as intrauterine devices [IUD], birth control pills or condoms) during the study period and for 6 months after the study ends; Have a negative serum pregnancy test within 28 days prior to study enrollment and must be a non-lactating subject; Men should be subjects who agree to use contraception during the study period and for 6 months after the end of the study period.
- 10. Subjects voluntarily joined the study, signed informed consent, 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 co-existing malignancies other than cured basal cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast (DCIS), papillary carcinoma of the thyroid gland, and other malignancies that have been adequately treated and cured for ≥5 years prior to the first dose with evidence of no recurrence or metastasis;
- 3. Presence of symptomatic or active central nervous system (CNS) metastases or cancerous meningitis (patients with asymptomatic or stable brain metastases after treatment are allowed to be included);
- 4. Active or previously suffering from autoimmune disease or immune deficiency;
- 5. In the first study, patients with clinically significant bleeding symptoms or bleeding tendency, such as hemoptysis, hematemesis, hematochezia, gastrointestinal bleeding, hemorrhagic gastric ulcer, etc., occurred within 3 months before medication;
- 6. Imaging (CT or MRI) shows that the tumor has invaded the large blood vessels or the boundary with the large blood vessels is unclear; Or if the investigator determines that the subject's tumor has a high risk of invading vital blood vessels during treatment and causing fatal bleeding;
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- 7. Have high blood pressure that is not well controlled by antihypertensive medication (systolic blood pressure >= 150mmHg or diastolic blood pressure >= 100 mmHg);
- 8. Cardiovascular and cerebrovascular diseases of significant clinical significance:
- Cerebrovascular accident (excluding lacunar infarction, minor cerebral ischemia, or transient ischemic attack), myocardial infarction, unstable angina pectoris, and poorly controlled arrhythmias (including QTc interval >= 450ms for men and 470 ms for women) occurred within 6 months before the first administration of the study drug (QTc interval >= 450ms for women) Fridericia formula);
- New York Heart Association (NYHA) heart function Grade > II or left ventricular ejection fraction (LVEF) < 50%;
- 9. Active or uncontrolled severe infection;
- Known human immunodeficiency virus (HIV) infection;
- Known history of clinically significant liver disease, including viral hepatitis [active HBV infection, i.e., HBV DNA positive (>1×104 copies /mL or >2000 IU/ml) must be excluded for a known HBV carrier;
- Known hepatitis C virus infection (HCV) and HCV RNA positive (>1×103 copies /mL), or other hepatitis, cirrhosis;
- 10. Patients with uncontrolled pleural effusion, pericardial effusion or peritoneal effusion in the third space, as judged by researchers, requiring puncture and drainage; Or received ascites, pleural effusion drainage within 14 days before the first medication;
- 11. Patients with interstitial pneumonia or interstitial lung disease, or a history of interstitial pneumonia or interstitial lung disease requiring hormone therapy, or other pulmonary fibrosis, chronic pneumonia, pneumonia due to drug or radiation therapy, a 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 examination;
- 12. Subjects who required systemic corticosteroids (> 10 mg/ day effective dose of prednisone) or other immunosuppressive agents within 14 days prior to initial dosing or during the study period. However, in the absence of active autoimmune disease, subjects were allowed to receive topical or inhaled steroids and adrenal hormone replacement therapy at a dose <=10 mg/ day of prednisone effectiveness;
- 13. The subject has any current disease or condition that affects drug absorption, or the subject is unable to take apatinib orally;
- 14. Urine routine indicated urinary protein >=2+, and 24-hour urinary protein quantity >1.0g;
- 15. The investigator considers that the subject is not suitable to participate in the clinical study due to any clinical or laboratory abnormalities or other reasons.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Fujian Cancer Hospital
Fuzhou, Fujian
Jinghui Lin, +86 13706990793, 2690213099@qq.com
Fujian Provincial Hospital
Fuzhou, Fujian
Jianping Zheng
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fuzhou
Rixiong Wang
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
Chunyue Wang
About this study
To evaluate the efficacy and safety of apatinib combined with adebrelizumab and EC in the first-line treatment of extensive small cell lung cancer
- Conditions
- Small Cell Lung Cancer Extensive Stage
- Being tested
- Apatinib, Adebrelimab, Etoposide Injection, Carboplatin Injection
- Keywords
- Adebrelimab, Apatinib, EC, Small cell lung cancer
- 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.
ApatinibDrug
250mg, P.O, qd, 21 days per cycle;
AdebrelimabDrug
20mg/kg or 1200mg ivgtt, d1, 21 days per cycle;
Etoposide InjectionDrug
100mg/m^2 ivgtt for the first, second and third consecutive days, 21 days per cycle.
Carboplatin InjectionDrug
Day 1 administration, AUC=5, intravenous infusion; One treatment cycle every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Apatinib; Drug: Adebrelimab; Drug: Etoposide Injection; Drug: Carboplatin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Defined as the time from the start of enrollment to the date when objective tumor progression was first recorded or to death from any cause, whichever occurs first.
Measured: 0ne year
Secondary outcomes (4)
Objective remission rate
Proportion of subjects with CR and PR (RECIST v1.1 standard)
Measured: one year
Disease control rate
Proportion of subjects with CR and PR and SD (RECIST v1.1 standard)
Measured: one year
Overall survival
Defined as the time between enrollment and the subject's death from various causes;
Measured: 2 years
Safety and tolerance evaluated by incidence, severity and outcomes of AEs
Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 5.0
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start25 Jan 2025 (estimated)
- Primary completion25 Jul 2027 (estimated)
- Study completion25 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer Extensive StageStudies 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
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786312
- Sponsor's protocol ID
- SCOG 010
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter, Prospective Phase II Clinical Study of Apatinib in Combination With Adebrelimab and EC Regimen in the First-line Treatment of Extensive Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06786312
- Acronym / sponsor ID
- SCOG 010
- Conditions
- Small Cell Lung Cancer Extensive Stage
- Keywords
- Adebrelimab, Apatinib, EC, Small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 25 Jan 2025 (estimated)
- Primary completion
- 25 Jul 2027 (estimated)
- Study completion
- 25 Sep 2028 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of apatinib combined with adebrelizumab and EC in the first-line treatment of extensive 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 |
|---|---|---|
| Experimental group | Experimental | Drug: Apatinib, Drug: Adebrelimab, Drug: Etoposide Injection, Drug: Carboplatin Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 1. Patients with extensive stage small cell lung cancer confirmed by histopathology or cytology (excluding complex small cell lung cancer);
- 2. Age at the time of signing the informed consent: 18-75 years old (including 18 and 75 years old), male or female;
- 3. The physical status of the Eastern Oncology Consortium (ECOG) was 0 or 1 (see Annex 1 for the ECOGPS scoring criteria);
- 4. Have not received systematic treatment for extensive small cell lung cancer;
- 5. Have at least one measurable lesion that meets the RECIST v1.1 standard (see Annex 3);
Key exclusion criteria (20 listed)
- 1. Known allergy to any of the drugs in the study;
- 2. Previous or co-existing malignancies other than cured basal cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast (DCIS), papillary carcinoma of the thyroid gland, and other malignancies that have been adequately treated and cured for ≥5 years prior to the first dose with evidence of no recurrence or metastasis;
- 3. Presence of symptomatic or active central nervous system (CNS) metastases or cancerous meningitis (patients with asymptomatic or stable brain metastases after treatment are allowed to be included);
- 4. Active or previously suffering from autoimmune disease or immune deficiency;
- 5. In the first study, patients with clinically significant bleeding symptoms or bleeding tendency, such as hemoptysis, hematemesis, hematochezia, gastrointestinal bleeding, hemorrhagic gastric ulcer, etc., occurred within 3 months before medication;
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 |
|---|---|---|
| Apatinib250mg, P.O, qd, 21 days per cycle; | Drug | Experimental group |
| Adebrelimab20mg/kg or 1200mg ivgtt, d1, 21 days per cycle; | Drug | Experimental group |
| Etoposide Injection100mg/m^2 ivgtt for the first, second and third consecutive days, 21 days per cycle. | Drug | Experimental group |
| Carboplatin InjectionDay 1 administration, AUC=5, intravenous infusion; One treatment cycle every 21 days. | Drug | Experimental group |
Primary outcome
Progression free survival
Time frame: 0ne year
Defined as the time from the start of enrollment to the date when objective tumor progression was first recorded or to death from any cause, whichever occurs first.
4 secondary outcomes
Objective remission rate
Time frame: one year
Disease control rate
Time frame: one year
Overall survival
Time frame: 2 years
Safety and tolerance evaluated by incidence, severity and outcomes of AEs
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib, Adebrelimab and Etoposide Injection in people with Small Cell Lung Cancer Extensive Stage, run by Fujian Cancer Hospital at 4 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 14 inclusion and 20 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 22 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 4 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.
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 Jinghui Lin (+86 13706990793, 2690213099@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 (time frame: 0ne year). 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 22 Jan 2025.