Small Cell Lung Cancer Extensive StageNCT06825208
Etoposide Plus Benmelstobart Followed by Maintenance Therapy of Benmelstobart Plus Anlotinib in First-line Treatment of Elderly Patients with Extensive Stage Small Cell Lung Cancer: a Single-arm, Prospective Trial
An observational study of Small Cell Lung Cancer Extensive Stage and ELDERLY PEOPLE, run by Nanjing First Hospital, Nanjing Medical University.
Trial summary
This is a prospective, single-arm clinical study to evaluate the efficacy and safety of etoposide in combination with bemosubezumab and sequential Benmelstobart in combination with Anlotinib as first-line treatment for elderly patients with extensive small-cell lung cancer. Read more about this study
- Who is it for?
- Ages 70 to 85 years
- Conditions the study is for
- Small Cell Lung Cancer Extensive Stage, ELDERLY PEOPLE
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Jun 2027
- Phase
- Observational
- 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 70 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients from Nanjing First Hospital
Who may be able to join
- Patients with pathologically proven extensive small-cell Lung cancer (according to the Veterans Administration Lung Study Group, VALG stage) who have not previously received systematic treatment for extensive small-cell lung cancer;
- Patients who have previously received chemoradiotherapy for limited-stage SCLC must have received radical therapy and have at least 6 months of treatment-free intervals between the end of chemotherapy, radiotherapy, or chemoradiotherapy and the diagnosis of extensive SCLC (end time of last chemotherapy cycle/end time of last radiotherapy).
- There was no gender limitation. The subjects voluntarily joined the study, signed the informed consent, and the compliance was good
- Aged eligibility criteria are considered to be met if the following criteria are met:
- Patient requirements: Between 70 and 85 years old, and after independent assessment by two chief physicians, the patient's physical condition may not be able to tolerate platinum-containing chemotherapy regimen, and the patient's informed consent to accept the platinum treatment regimen;
- ECOG score: 0-2;
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- At least one lesion can be measured by CT.
- Expect to survive for at least 3 months.
- The main organ functions within 7 days before treatment should meet the following criteria:
- 1) Blood routine examination (under the condition of no blood transfusion or use of hematopoietic stimulating factor drugs for correction within 14 days): Hemoglobin (Hb) ≥ 90g/L; Absolute neutrophil count (ANC) ≥ 1.5×109/L; ； 1) Platelet count (PLT) ≥ 100×10⁹/L; white blood cell count (WBC) ≥ 3.0×10⁹/L.
- 2) Biochemical tests: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (for patients with liver metastasis from tumors, ≤ 5×ULN); total bilirubin (TBIL) ≤ 1.5×ULN (for Gilbert's syndrome patients, ≤ 3×ULN); serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance rate ≥ 50 ml/min; 3) Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN; 4) Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥ 50%. 。
- Men should agree that contraception must be used during the study period and for 6 months after the end of the study period;
Who cannot join
- Used antiangiogenic drugs or related immunotherapy drugs such as PD-1 and PD-L1 in the past;
- Subjects with known central nervous system metastatic and/or cancerous meningitis; (Unless asymptomatic, or treated and stable, no radiographic evidence of new BMS or enlarged BMS was found at least 2 weeks after BMS treatment, and steroid or anticonvulsant therapy was discontinued for at least 14 days before study therapy began. If active or new untreated, asymptomatic CNS metastases are found on imaging in subjects during the screening period, radiation therapy or untreated imaging evidence of new or enlarged BMS is required for at least 2 weeks.)
- Subject has had or co-developed other malignancies (except cured basal cell carcinoma of the skin and cervical carcinoma in situ) within 5 years;
- Subject has multiple factors that affect oral medication (such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction);
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- Spinal cord compression that has not been cured or alleviated by surgery and/or radiotherapy, or previously diagnosed spinal cord compression with no clinical evidence of disease stabilization ≥1 week prior to randomization after treatment;
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- Imaging (CT or MRI) shows that the tumor invades the large blood vessels or has an unclear boundary with the large blood vessels;
- Subjects with evidence or history of bleeding tendencies, regardless of severity, within 2 months prior to initial dosing; A history of hemoptysis (defined as bright red or 1/2 teaspoon of blood) or unhealed wounds, ulcers, or fractures within 2 weeks prior to initial medication;
- Subjects whose adverse events (other than alopecia) from prior treatment did not recover to ≤CTCAE Class 1;
- Received major surgical treatment or significant traumatic injury within 28 days prior to randomization;
- Those who had experienced an arterial/venous thrombosis event, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism, within 6 months before randomization;
- have a history of psychotropic drug abuse and can not quit or have mental disorders;
- Subjects with any severe and/or uncontrolled medical condition, including:
- Subjects with unsatisfactory blood pressure control (systolic ≥150 mmHg or diastolic ≥100mmHg); b) have grade 2 myocardial ischemia or myocardial infarction, arrhythmias (including QTc≥450ms in men, QTc≥ 470ms in women), and grade 2 congestive heart failure (NYHA); c) Active or uncontrolled severe infection (≥CTC AE grade 2 infection); d) Cirrhosis, active hepatitis *;
- Active hepatitis (Hepatitis B reference :HBsAg positive, and HBV DNA test value exceeds the upper limit of normal; Hepatitis C reference :HCV antibody positive, and HCV virus titer test value exceeds the upper limit of normal value); e) HIV positive test; f) Poor diabetes control (fasting blood glucose (FBG)>10mmol/L); g) Urine routine indicated urine protein ≥++, and confirmed 24-hour urine protein quantity >1.0 g;
- have received prophylactic or attenuated vaccine within 4 weeks before the first dose;
- Severe hypersensitivity after administration of other monoclonal antibodies;
- The need for systemic treatment (e.g., use of disease-modifying drugs, Active autoimmune diseases with corticosteroids or immunosuppressants (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; Patients with asthma requiring medical intervention with bronchodilators were not included). Replacement therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic.
- have been diagnosed with an immune deficiency or are receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose >10mg/ day prednisone or other therapeutic hormone) and continue to use within 2 weeks before the first dose;
- Have participated in other clinical trials within four weeks;
- concomitant diseases that, in the investigator's judgment, seriously endanger the safety of the subject or interfere with the patient's completion of the 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
This is a prospective, single-arm clinical study to evaluate the efficacy and safety of etoposide in combination with bemosubezumab and sequential Benmelstobart in combination with Anlotinib as first-line treatment for elderly patients with extensive small-cell lung cancer.
Participants who met the inclusion criteria were selected to enter the study and received etoposide combined with Benmelstobart followed by bemosubezumab combined with Anlotinib. The primary endpoint was PFS (Progression-free Survival), the secondary endpoint was OS (Overall Survival) and safety (CTCAE 5.0), and the exploratory endpoint was the screening of various potential molecular markers.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elderly patients with extensive stage small cell lung cancer | Elderly patients with extensive small-cell lung cancer who have not previously received systematic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival time
It is the time that passes from a certain date (generally the first day of treatment, or the day in which a patient is enrolled in a clinical trial) and the date on which disease "progresses" or the date on which the patient dies, from any cause.
Measured: From enrollment to the end of treatment at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (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 Nanjing First Hospital, Nanjing Medical UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fangsurong, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825208
- Sponsor's protocol ID
- 2450-E-A-ES-SCLC-001
- Status last verified
- Feb 2025
- First submitted
- 9 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etoposide Plus Benmelstobart Followed by Maintenance Therapy of Benmelstobart Plus Anlotinib in First-line Treatment of Elderly Patients with Extensive Stage Small Cell Lung Cancer: a Single-arm, Prospective Trial
- ClinicalTrials.gov ID
- NCT06825208
- Acronym / sponsor ID
- 2450-E-A-ES-SCLC-001
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 Feb 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.
This is a prospective, single-arm clinical study to evaluate the efficacy and safety of etoposide in combination with bemosubezumab and sequential Benmelstobart in combination with Anlotinib as first-line treatment for elderly patients with extensive small-cell lung cancer.
Participants who met the inclusion criteria were selected to enter the study and received etoposide combined with Benmelstobart followed by bemosubezumab combined with Anlotinib. The primary endpoint was PFS (Progression-free Survival), the secondary endpoint was OS (Overall Survival) and safety (CTCAE 5.0), and the exploratory endpoint was the screening of various potential molecular markers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly patients with extensive stage small cell lung cancer | – | –Elderly patients with extensive small-cell lung cancer who have not previously received systematic treatment |
Who may qualify
- Ages
- 70 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients from Nanjing First Hospital
Key inclusion criteria (12 listed)
- Patients with pathologically proven extensive small-cell Lung cancer (according to the Veterans Administration Lung Study Group, VALG stage) who have not previously received systematic treatment for extensive small-cell lung cancer;
- Patients who have previously received chemoradiotherapy for limited-stage SCLC must have received radical therapy and have at least 6 months of treatment-free intervals between the end of chemotherapy, radiotherapy, or chemoradiotherapy and the diagnosis of extensive SCLC (end time of last chemotherapy cycle/end time of last radiotherapy).
- There was no gender limitation. The subjects voluntarily joined the study, signed the informed consent, and the compliance was good
- Aged eligibility criteria are considered to be met if the following criteria are met:
- Patient requirements: Between 70 and 85 years old, and after independent assessment by two chief physicians, the patient's physical condition may not be able to tolerate platinum-containing chemotherapy regimen, and the patient's informed consent to accept the platinum treatment regimen;
Key exclusion criteria (21 listed)
- Used antiangiogenic drugs or related immunotherapy drugs such as PD-1 and PD-L1 in the past;
- Subjects with known central nervous system metastatic and/or cancerous meningitis; (Unless asymptomatic, or treated and stable, no radiographic evidence of new BMS or enlarged BMS was found at least 2 weeks after BMS treatment, and steroid or anticonvulsant therapy was discontinued for at least 14 days before study therapy began. If active or new untreated, asymptomatic CNS metastases are found on imaging in subjects during the screening period, radiation therapy or untreated imaging evidence of new or enlarged BMS is required for at least 2 weeks.)
- Subject has had or co-developed other malignancies (except cured basal cell carcinoma of the skin and cervical carcinoma in situ) within 5 years;
- Subject has multiple factors that affect oral medication (such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction);
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-free survival time
Time frame: From enrollment to the end of treatment at 18 months
It is the time that passes from a certain date (generally the first day of treatment, or the day in which a patient is enrolled in a clinical trial) and the date on which disease "progresses" or the date on which the patient dies, from any cause.
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 13 Feb 2025.
- 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?
An observational study of Small Cell Lung Cancer Extensive Stage and ELDERLY PEOPLE, run by Nanjing First Hospital, Nanjing Medical 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 12 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: opening soon, as of the sponsor's last update on 13 Feb 2025. 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.
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 Surong Fang (+86 15651981839, fangsurongjiang@126.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 (time frame: From enrollment to the end of treatment at 18 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 13 Feb 2025.