SCLCPhase 2NCT06475209
Adebrelimab + Apatinib in SCLC Maintenance Therapy
A Phase 2 study testing Adebrelimab combined with Apatinib in people with SCLC, run by Tang-Du Hospital at 1 site in China.
Trial summary
This prospective clinical study aims to evaluate and observe the efficacy and safety of Atezolizumab combined with Apatinib in maintenance therapy for extensive-stage small cell lung cancer using a single-arm trial design. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SCLC
- What is being tested?
- Adebrelimab combined with Apatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2024to 20 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
- Voluntary participation with signed informed consent and good compliance for follow-up.
- Age between 18 and 75 years old.
- Histologically or cytologically confirmed extensive-stage small cell lung cancer (LS-SCLC) according to the AJCC 8th edition or VALG phase II staging criteria.
- ECOG performance status score: 0 to 2.
- Absence of disease progression after receiving 4-6 cycles of platinum-based chemotherapy combined with Atezolizumab induction therapy.
- Recovery of non-hematologic adverse reactions to grade 1 (except for alopecia, skin pigment changes, or as determined by the investigator) following induction therapy.
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- Time from the end of induction treatment (last dose) to initiation of maintenance treatment ≤ 6 weeks.
- At least one measurable lesion assessed by the investigator according to RECIST 1.1.
- Expected life expectancy of at least 3 months.
- Normal function of major organs, meeting the following criteria:
- Bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5×10^9/L (grade 1 according to CTCAE 5.0); platelets ≥ 100×10^9/L; hemoglobin > 80g/L.
- Renal function: Creatinine ≤ 1.5 times the upper limit of normal (ULN), grade 1 according to CTCAE. Note: If creatinine is greater than 1.5 times the ULN, creatinine clearance must be > 50ml/min.
- Liver function: Bilirubin ≤ 1.5 times ULN (grade 1 according to CTCAE), patients with Gilbert's syndrome bilirubin ≤ 3.0 times ULN; AST and ALT ≤ 3.0×ULN.
- Coagulation indicators: International normalized ratio (INR) ≤ 1.55 (if the patient is receiving a stable dose of therapeutic warfarin or low molecular weight heparin, INR is usually between 2 and 3), PTT < 1.2 times ULN.
- Women of childbearing potential must agree to use contraception during the study and for 6 months after the end of the study (such as an intrauterine device, contraceptive pills, or condoms); serum or urine pregnancy test must be negative within 1 week before enrollment, and must be non-lactating patients; men must agree to use contraception during the study and for 6 months after the end of the study.
Who cannot join
- -
- Limited-stage small cell lung cancer (SCLC).
- Histologically or cytologically confirmed mixed-type SCLC.
- Prior use of anti-angiogenic drugs or deemed unsuitable for anti-angiogenic therapy by the investigator.
- Central tumors invading major blood vessels with assessed bleeding risks.
- Factors affecting oral medication (e.g., dysphagia, chronic diarrhea, intestinal obstruction).
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- Major surgical procedures, incisional biopsies, or significant traumatic injuries within 4 weeks prior to enrollment.
- Participation in another investigational drug clinical trial within the past 4 weeks.
- Medical history including:
- Untreated or symptomatic brain metastases or spinal cord compression.
- Concurrent active malignant tumors requiring treatment.
- History of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency diseases, or organ transplant recipients.
- History of substance abuse disorders not amenable to treatment or psychiatric disorders.
- Presence of any severe and/or uncontrolled diseases including:
- Poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg).
- Ischemic heart disease or myocardial infarction of grade I or higher, arrhythmias (including QTc ≥ 450ms for males, QTc ≥ 470ms for females), and ≥ grade 2 congestive heart failure (New York Heart Association [NYHA] functional classification); or left ventricular ejection fraction (LVEF) < 50% based on echocardiography.
- Decompensated diabetes or other contraindications to high-dose corticosteroid therapy.
- Worsening chronic obstructive pulmonary disease (COPD) or other severe respiratory diseases requiring hospitalization.
- Active or uncontrolled severe infections (≥ CTC AE grade 2).
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- Liver cirrhosis, decompensated liver disease, active hepatitis, or chronic hepatitis requiring antiviral therapy.
- Renal insufficiency: Urine protein ≥ ++ on urinalysis, and confirmed 24-hour urine protein quantitation > 1.0 g.
- Clinically significant hemoptysis (>1/2 teaspoon of fresh blood) or significant bleeding symptoms within the past 3 months prior to enrollment, or evidence of bleeding tendency such as gastrointestinal bleeding, bleeding gastric ulcers, baseline fecal occult blood test ≥ ++, or non-healed wounds, ulcers, or fractures.
- Occurrence of venous or arterial thrombotic events within the past 6 months prior to enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhages, cerebral infarctions), deep vein thrombosis, and pulmonary embolism.
- Abnormal coagulation function (INR > 1.5 or prothrombin time PT > ULN + 4 seconds or APTT > 1.5 ULN), bleeding tendency, or undergoing thrombolysis or anticoagulant therapy. Use of low-dose heparin (adult daily dose of 0.6-1.2 x 104U) or low-dose aspirin (daily dose ≤ 100 mg) is permitted for prophylactic purposes with INR ≤ 1.5.
- Patients unable to comply with study procedures, restrictions, and requirements as judged by the investigator are ineligible for participation.
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
Jie Min, Dr
About this study
Official title: Observational Study on the Efficacy and Safety of Adebrelimab Combined With Apatinib in Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer
This prospective clinical study aims to evaluate and observe the efficacy and safety of Atezolizumab combined with Apatinib in maintenance therapy for extensive-stage small cell lung cancer using a single-arm trial design.
The study is planned to be conducted in Shaanxi Province, China, with an initial target enrollment of 60 patients. The study commenced in February 2024, and recruitment is expected to conclude around December 2025, with the trial anticipated to end by December 2026. Assuming no occurrences such as withdrawal of informed consent by subjects, intolerable adverse drug reactions, or investigator-assessed unsuitability for further participation, each participant's estimated duration of study treatment will continue until radiographically confirmed tumor progression.
- Conditions
- SCLC
- Being tested
- Adebrelimab combined with Apatinib
- Keywords
- SCLC, Adebrelimab, Apatinib, Maintenance Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab combined with ApatinibDrug
Each treatment cycle spans 3 weeks. Sequential medication administration begins on the first day of each cycle: Atezolizumab is administered at a dosage of 1200mg on day 1, every 3 weeks, while Apatinib is given orally at a dosage of 250mg daily from day 1 to day 14, every 3 weeks, with a one-week hiatus following two weeks of continuous intake. Administration timing allows for a window of ±5 days. Subjects are required to undergo comprehensive assessments, including vital signs monitoring, anthropometric measurements, physical examinations, laboratory analyses, and performance status evaluations, to assess treatment tolerability for continuation.
| Study group | Role | What they receive |
|---|---|---|
| Adebrelimab combined with Apatinib | Experimental | Evaluation of the Efficacy and Safety of Adebrelimab in Combination with Apatinib in Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer Each treatment cycle spans 3 weeks. Sequential medication administration begins on the first day of each cycle: Adebrelimab is administered at a dosage of 1200mg on day 1, every 3 weeks, while Apatinib is given orally at a dosage of 250mg daily from day 1 to day 14, every 3 weeks, with a one-week hiatus following two weeks of continuous intake. Administration timing allows for a window of ±5 days. Subjects are required to undergo comprehensive assessments, including vital signs monitoring, anthropometric measurements, physical examinations, laboratory analyses, and performance status evaluations, to assess treatment tolerability for continuation. Receives: Drug: Adebrelimab combined with Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression free survival (PFS) refers to the time from recording the first chemotherapy treatment to the date of disease progression, as assessed by researchers.
Measured: Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years
Secondary outcomes (4)
Overall Survival
Overall survival (OS) refers to the time that researchers evaluate from recording the first chemotherapy to death (of any cause).
Measured: The maximum time from receiving treatment to dying for any reason is 4 years.
Objective response rate
Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with response of Complete Response or Partial Response, will be assessed up to 1 years.
Measured: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years
Complete Response rate
Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with response of Complete Response, will be assessed up to 1 years.
Measured: up to 1 years
Duration of Response
Duration of Response（DoR）refers to the time from the first assessment as CR or PR to the first assessment as PD or (due to any reason) death
Measured: Duration of Response（DoR）analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start20 Jun 2024 (estimated)
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLCStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475209
- Sponsor's protocol ID
- 202404-25
- Status last verified
- Jun 2024
- First submitted
- 20 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Efficacy and Safety of Adebrelimab Combined With Apatinib in Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06475209
- Acronym / sponsor ID
- 202404-25
- Conditions
- SCLC
- Keywords
- SCLC, Adebrelimab, Apatinib, Maintenance Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Study start
- 20 Jun 2024 (estimated)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 26 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.
This prospective clinical study aims to evaluate and observe the efficacy and safety of Atezolizumab combined with Apatinib in maintenance therapy for extensive-stage small cell lung cancer using a single-arm trial design.
The study is planned to be conducted in Shaanxi Province, China, with an initial target enrollment of 60 patients. The study commenced in February 2024, and recruitment is expected to conclude around December 2025, with the trial anticipated to end by December 2026. Assuming no occurrences such as withdrawal of informed consent by subjects, intolerable adverse drug reactions, or investigator-assessed unsuitability for further participation, each participant's estimated duration of study treatment will continue until radiographically confirmed tumor progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adebrelimab combined with Apatinib | Experimental | Drug: Adebrelimab combined with ApatinibEvaluation of the Efficacy and Safety of Adebrelimab in Combination with Apatinib in Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer Each treatment cycle spans 3 weeks. Sequential medication administration begins on the first day of each cycle: Adebrelimab is administered at a dosage of 1200mg on day 1, every 3 weeks, while Apatinib is given orally at a dosage of 250mg daily from day 1 to day 14, every 3 weeks, with a one-week hiatus following two weeks of continuous intake. Administration timing allows for a window of ±5 days. Subjects are required to undergo comprehensive assessments, including vital signs monitoring, anthropometric measurements, physical examinations, laboratory analyses, and performance status evaluations, to assess treatment tolerability for continuation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Voluntary participation with signed informed consent and good compliance for follow-up.
- Age between 18 and 75 years old.
- Histologically or cytologically confirmed extensive-stage small cell lung cancer (LS-SCLC) according to the AJCC 8th edition or VALG phase II staging criteria.
- ECOG performance status score: 0 to 2.
- Absence of disease progression after receiving 4-6 cycles of platinum-based chemotherapy combined with Atezolizumab induction therapy.
Key exclusion criteria (26 listed)
- -
- Limited-stage small cell lung cancer (SCLC).
- Histologically or cytologically confirmed mixed-type SCLC.
- Prior use of anti-angiogenic drugs or deemed unsuitable for anti-angiogenic therapy by the investigator.
- Central tumors invading major blood vessels with assessed bleeding risks.
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 combined with ApatinibEach treatment cycle spans 3 weeks. Sequential medication administration begins on the first day of each cycle: Atezolizumab is administered at a dosage of 1200mg on day 1, every 3 weeks, while Apatinib is given orally at a dosage of 250mg daily from day 1 to day 14, every 3 weeks, with a one-week hiatus following two weeks of continuous intake. Administration timing allows for a window of ±5 days. Subjects are required to undergo comprehensive assessments, including vital signs monitoring, anthropometric measurements, physical examinations, laboratory analyses, and performance status evaluations, to assess treatment tolerability for continuation. | Drug | Adebrelimab combined with Apatinib |
Primary outcome
Progression-free survival
Time frame: Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years
Progression free survival (PFS) refers to the time from recording the first chemotherapy treatment to the date of disease progression, as assessed by researchers.
4 secondary outcomes
Overall Survival
Time frame: The maximum time from receiving treatment to dying for any reason is 4 years.
Objective response rate
Time frame: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years
Complete Response rate
Time frame: up to 1 years
Duration of Response
Time frame: Duration of Response（DoR）analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 1 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 26 Jun 2024.
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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 combined with Apatinib in people with 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 15 inclusion and 26 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 26 Jun 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 Jie Min, Dr (13709202616, Minjie1504@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 (time frame: Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years). 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 Jun 2024.