Small Cell Lung Cancer ( SCLC )Phase 3SCLCNCT07728955
A Single-arm, Exploratory Clinical Study Evaluating the Efficacy and Safety of Bevacizumab in Combination With Anlotinib and Etoposide as First-line Therapy for Elderly Patients With Small-cell Lung Cancer or Those Who Are Intolerant to Intensive Chemotherapy
A Phase 3 study testing benmelstobart in combination with anlotinib and etoposide in people with Small Cell Lung Cancer ( SCLC ), run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
A single-arm exploratory clinical study to observe and evaluate the first-line treatment of elderly and treatment-intolerant patients with small cell lung cancer using benmelstobart in combination with anlotinib and etoposide. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Small Cell Lung Cancer ( SCLC )
- What is being tested?
- benmelstobart in combination with anlotinib and etoposide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Aug 2028
- Phase
- Phase 3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject must voluntarily participate in this study after being fully informed and must sign a written informed consent form (ICF), and be willing and able to comply with the study procedures and requirements.
- At the time of signing the ICF, male or female subjects aged ≥65 years, or male or female subjects aged ≥18 years who are assessed by the investigator as not suitable for intensive treatment, defined as: ECOG performance status of 2-3, or comorbidities (CIRS >6 and ≤12), or otherwise judged by the investigator as not suitable for intensive treatment. Intensive treatment is defined as first-line intensive therapy for metastatic small cell lung cancer, i.e., standard chemotherapy with etoposide plus cisplatin or carboplatin combined with immune checkpoint inhibitors and targeted agents.
- Histologically or cytologically confirmed metastatic small cell lung cancer (SCLC), according to the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer TNM staging system, 9th edition (AJCC 9th).
- Subjects must not have received prior systemic therapy for metastatic SCLC. Patients who previously received adjuvant, neoadjuvant, or radical chemoradiotherapy for non-metastatic disease are eligible if disease progression occurred >6 months after completion of the last treatment.
- At least one measurable target lesion according to RECIST v1.1. Lesions previously treated with radiotherapy or other local regional therapy are not considered target lesions unless clear progression is documented after treatment. Lesions must have a longest diameter ≥10 mm on CT or MRI at baseline (lymph nodes must have a short axis ≥15 mm), and must be suitable for repeated accurate measurement per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
- Adequate organ function as defined below, with no blood transfusion or use of hematopoietic growth factors within 14 days prior to testing: Platelets (PLT) ≥80 × 10⁹/L Hemoglobin (HGB) ≥80 g/L Neutrophils (NEUT) ≥1.5 × 10⁹/L Creatinine ≤1.5 × upper limit of normal (ULN) or creatinine clearance (CrCl) ≥30 mL/min (Cockcroft-Gault) ALT and AST ≤2.5 × ULN (≤5 × ULN if liver metastases present) Total bilirubin (TBIL) ≤1.5 × ULN (≤3 × ULN in Gilbert's syndrome) INR or PT ≤1.5 × ULN and APTT ≤1.5 × ULN, or clinically acceptable bleeding risk as assessed by investigator Urine protein <2+ or 24-hour urine protein <1 g Expected survival ≥3 months Women of childbearing potential must agree to use effective contraception during and for 6 months after the study and have a negative serum pregnancy test within 7 days before enrollment and must not be breastfeeding Male subjects must agree to use effective contraception during and for 6 months after the study Willingness to participate and good compliance with follow-up.
Who cannot join
- Prior anti-cancer therapy within specified time windows: Anti-PD-1/PD-L1 therapy within 3 years before first dose Anti-angiogenic multi-target TKIs (e.g., anlotinib, apatinib) within 3 years Any anti-cancer therapy (chemotherapy, targeted therapy, immunotherapy, etc.) or investigational drug within 28 days before first dose Traditional Chinese medicines with approved anti-cancer indications within 2 weeks before first dose (e.g., Fufang Banmao capsule, Kang'ai injection, Kanglaite capsule/injection, Aidi injection, Yadanzi oil injection/capsule, Xiaoaiping tablets/injection, Huachansu capsule, etc.)
- Other primary malignancies, except: Tumors treated by single surgery with complete remission ≥3 years before enrollment Non-melanoma skin cancer or in situ cancers not requiring treatment Prostate cancer requiring only clinical observation
- Symptomatic or progressing CNS metastases or carcinomatous meningitis. Patients with stable brain metastases may be eligible if: No neurological symptoms No corticosteroid use required and no indication for radiotherapy Largest brain lesion ≤1.5 cm Stable on two brain MRI/CT scans ≥2 weeks apart Additional timing and stability conditions after CNS treatment as specified Off corticosteroids ≥2 weeks if previously treated with CNS radiotherapy ≥4 weeks interval after CNS surgery before first dose
- Cardiovascular conditions including: NYHA class II or higher heart failure Severe arrhythmia requiring treatment Myocardial infarction, unstable angina, or vascular bypass within 6 months LVEF <40% QTcF prolongation (female >470 ms, male >450 ms) or risk factors for torsades de pointes Uncontrolled hypertension (SBP ≥150 mmHg and/or DBP ≥100 mmHg despite treatment)
- Thrombotic events within 6 months (e.g., stroke, TIA, DVT, pulmonary embolism), hypertensive crisis, or encephalopathy.
- History of epilepsy.
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- Superior vena cava syndrome.
- Active or uncontrolled pulmonary conditions including interstitial lung disease, radiation pneumonitis, immune-related pneumonitis, active tuberculosis, pneumoconiosis, or severe pulmonary impairment (FEV1, DLCO, or DLCO/VA <40%).
- Severe bone metastasis-related complications (e.g., pathological fracture, spinal cord compression, uncontrolled bone pain).
- Active uncontrolled infection (≥CTCAE grade 2) or fever >38.5°C of unknown cause.
- Uncontrolled third-space fluid accumulation (pleural, peritoneal, pericardial effusion), unless stable after drainage.
- Tumor invasion or unclear boundary with major blood vessels on imaging.
- Bleeding tendency within 2 months or hemoptysis (>2.5 mL/day) within 2 weeks, or unhealed wounds/ulcers/fractures.
- Significant gastrointestinal disease affecting drug absorption (e.g., severe ulcers, cirrhosis, bowel obstruction, IBD, surgery affecting absorption, etc.).
- Live attenuated vaccine within 4 weeks before first dose.
- Severe hypersensitivity to monoclonal antibody therapies.
- Active autoimmune disease requiring systemic therapy within 2 years (excluding replacement therapies).
- Immunodeficiency or ongoing immunosuppressive therapy (>10 mg/day prednisone equivalent) within 2 weeks before dosing.
- HIV positivity, active hepatitis B or C infection as defined by HBV DNA or HCV RNA thresholds.
- Active syphilis, dialysis-dependent renal failure.
- Poorly controlled diabetes (fasting glucose >10 mmol/L).
- History of organ transplantation or planned transplantation.
- Major surgery or significant trauma within 4 weeks before first dose.
- Palliative radiotherapy within 2 weeks before first dose.
- Unresolved prior treatment toxicities (except alopecia/pigmentation/lab abnormalities not clinically significant); peripheral neuropathy not recovered to ≤Grade 2.
- Pregnancy or breastfeeding.
- Severe psychiatric illness, drug abuse, or alcoholism.
- Known allergy to study drug or any of its components.
- Any other clinically significant condition that may compromise safety or interfere with study assessments as judged by the investigator.
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
A single-arm exploratory clinical study to observe and evaluate the first-line treatment of elderly and treatment-intolerant patients with small cell lung cancer using benmelstobart in combination with anlotinib and etoposide.
Eligible patients are those with histologically or pathologically confirmed small cell lung cancer (SCLC) (AJCC 9th edition), who are treatment-naïve and considered elderly or intolerant to intensive therapy. Eligible subjects receive 4-6 cycles of benmelstobart injection combined with anlotinib hydrochloride and etoposide, followed by maintenance therapy with benmelstobart injection plus anlotinib hydrochloride, continued until disease progression or intolerable toxicity.
The study aims to evaluate the efficacy and safety of first-line treatment with benmelstobart injection in combination with anlotinib hydrochloride and etoposide in patients with advanced SCLC.
- Conditions
- Small Cell Lung Cancer ( SCLC )
- Being tested
- benmelstobart in combination with anlotinib and 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.
benmelstobart in combination with anlotinib and etoposideDrug
Platinum-free regimen
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: benmelstobart in combination with anlotinib and etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from the first dose of study treatment to the first documented disease progression or death due to any cause, whichever occurs first.
Measured: From first dose of study treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Secondary outcomes (6)
Objective Response Rate（ORR）
ORR is defined as the percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: Through study completion, an average of 1 year.
Disease Control Rate (DCR)
Measured: Through study completion, an average of 1 year.
Duration of Response (DoR)
Measured: From the date of first documented response (CR or PR) until the date of first documented disease progression or death, whichever came first, assessed up to 24 months.
Overall Survival (OS)
Measured: From first dose of study treatment until date of death from any cause, assessed up to 36 months.
Safety and Tolerability
Safety will be evaluated by summarizing the incidence of AEs, irAEs, and SAEs graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v6.0.
Measured: From first dose of study treatment until 30 days after last dose, assessed up to 24 months.
Cancer-Specific Survival (CSS)
Measured: From first dose of study treatment until date of death due to small cell lung cancer , assessed up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Aug 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 ( SCLC )Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728955
- Sponsor's protocol ID
- SYSU-SQ-2026014
- Acronym
- SCLC
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Exploratory Clinical Study Evaluating the Efficacy and Safety of Bevacizumab in Combination With Anlotinib and Etoposide as First-line Therapy for Elderly Patients With Small-cell Lung Cancer or Those Who Are Intolerant to Intensive Chemotherapy
- ClinicalTrials.gov ID
- NCT07728955
- Acronym / sponsor ID
- SCLC / SYSU-SQ-2026014
- Conditions
- Small Cell Lung Cancer ( SCLC )
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 27 Jul 2026 (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 single-arm exploratory clinical study to observe and evaluate the first-line treatment of elderly and treatment-intolerant patients with small cell lung cancer using benmelstobart in combination with anlotinib and etoposide.
Eligible patients are those with histologically or pathologically confirmed small cell lung cancer (SCLC) (AJCC 9th edition), who are treatment-naïve and considered elderly or intolerant to intensive therapy. Eligible subjects receive 4-6 cycles of benmelstobart injection combined with anlotinib hydrochloride and etoposide, followed by maintenance therapy with benmelstobart injection plus anlotinib hydrochloride, continued until disease progression or intolerable toxicity.
The study aims to evaluate the efficacy and safety of first-line treatment with benmelstobart injection in combination with anlotinib hydrochloride and etoposide in patients with advanced SCLC.
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: benmelstobart in combination with anlotinib and etoposide |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subject must voluntarily participate in this study after being fully informed and must sign a written informed consent form (ICF), and be willing and able to comply with the study procedures and requirements.
- At the time of signing the ICF, male or female subjects aged ≥65 years, or male or female subjects aged ≥18 years who are assessed by the investigator as not suitable for intensive treatment, defined as: ECOG performance status of 2-3, or comorbidities (CIRS >6 and ≤12), or otherwise judged by the investigator as not suitable for intensive treatment. Intensive treatment is defined as first-line intensive therapy for metastatic small cell lung cancer, i.e., standard chemotherapy with etoposide plus cisplatin or carboplatin combined with immune checkpoint inhibitors and targeted agents.
- Histologically or cytologically confirmed metastatic small cell lung cancer (SCLC), according to the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer TNM staging system, 9th edition (AJCC 9th).
- Subjects must not have received prior systemic therapy for metastatic SCLC. Patients who previously received adjuvant, neoadjuvant, or radical chemoradiotherapy for non-metastatic disease are eligible if disease progression occurred >6 months after completion of the last treatment.
- At least one measurable target lesion according to RECIST v1.1. Lesions previously treated with radiotherapy or other local regional therapy are not considered target lesions unless clear progression is documented after treatment. Lesions must have a longest diameter ≥10 mm on CT or MRI at baseline (lymph nodes must have a short axis ≥15 mm), and must be suitable for repeated accurate measurement per RECIST v1.1.
Key exclusion criteria (29 listed)
- Prior anti-cancer therapy within specified time windows: Anti-PD-1/PD-L1 therapy within 3 years before first dose Anti-angiogenic multi-target TKIs (e.g., anlotinib, apatinib) within 3 years Any anti-cancer therapy (chemotherapy, targeted therapy, immunotherapy, etc.) or investigational drug within 28 days before first dose Traditional Chinese medicines with approved anti-cancer indications within 2 weeks before first dose (e.g., Fufang Banmao capsule, Kang'ai injection, Kanglaite capsule/injection, Aidi injection, Yadanzi oil injection/capsule, Xiaoaiping tablets/injection, Huachansu capsule, etc.)
- Other primary malignancies, except: Tumors treated by single surgery with complete remission ≥3 years before enrollment Non-melanoma skin cancer or in situ cancers not requiring treatment Prostate cancer requiring only clinical observation
- Symptomatic or progressing CNS metastases or carcinomatous meningitis. Patients with stable brain metastases may be eligible if: No neurological symptoms No corticosteroid use required and no indication for radiotherapy Largest brain lesion ≤1.5 cm Stable on two brain MRI/CT scans ≥2 weeks apart Additional timing and stability conditions after CNS treatment as specified Off corticosteroids ≥2 weeks if previously treated with CNS radiotherapy ≥4 weeks interval after CNS surgery before first dose
- Cardiovascular conditions including: NYHA class II or higher heart failure Severe arrhythmia requiring treatment Myocardial infarction, unstable angina, or vascular bypass within 6 months LVEF <40% QTcF prolongation (female >470 ms, male >450 ms) or risk factors for torsades de pointes Uncontrolled hypertension (SBP ≥150 mmHg and/or DBP ≥100 mmHg despite treatment)
- Thrombotic events within 6 months (e.g., stroke, TIA, DVT, pulmonary embolism), hypertensive crisis, or encephalopathy.
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 |
|---|---|---|
| benmelstobart in combination with anlotinib and etoposidePlatinum-free regimen | Drug | Experimental group |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From first dose of study treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Progression-Free Survival (PFS) is defined as the time from the first dose of study treatment to the first documented disease progression or death due to any cause, whichever occurs first.
6 secondary outcomes
Objective Response Rate（ORR）
Time frame: Through study completion, an average of 1 year.
Disease Control Rate (DCR)
Time frame: Through study completion, an average of 1 year.
Duration of Response (DoR)
Time frame: From the date of first documented response (CR or PR) until the date of first documented disease progression or death, whichever came first, assessed up to 24 months.
Overall Survival (OS)
Time frame: From first dose of study treatment until date of death from any cause, assessed up to 36 months.
Safety and Tolerability
Time frame: From first dose of study treatment until 30 days after last dose, assessed up to 24 months.
Cancer-Specific Survival (CSS)
Time frame: From first dose of study treatment until date of death due to small cell lung cancer , assessed up to 36 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 27 Jul 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing benmelstobart in combination with anlotinib and etoposide in people with Small Cell Lung Cancer ( SCLC ), run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
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 7 inclusion and 29 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 27 Jul 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Heping Li (+86 13710873975, liheping@mail.sysu.edu.cn), 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: From first dose of study treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 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 27 Jul 2026.