Extensive-stage Small Cell Lung CancerPhase 4NCT06931145
Benmelstobart, Anlotinib and Chemotherapy as First-line Treatment for Extensive-stage Small-cell Lung Cancer
A Phase 4 study testing Benmelstobart, Anlotinib and Carboplatin or cisplatin in people with Extensive-stage Small Cell Lung Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of benmelstobart in combination with anlotinib and chemotherapy sequential benmelstobart in combination with anlotinib for 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?
- Benmelstobart, Anlotinib and Carboplatin or cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2025to 31 Dec 2027
- Phase
- Phase 4
- 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 pathologically confirmed extensive stage small cell lung cancer (VALG stage).
- 2. No prior systemic therapy for extensive-stage small cell lung cancer;
- 3. Patients who have received prior radiotherapy for limited-stage SCLC must have received radical therapy with a treatment-free interval of at least 6 months between the end of chemotherapy, radiotherapy, or radiochemotherapy and the diagnosis of extensive-stage SCLC (counting the time of completion of the last cycle of chemotherapy/time of completion of the last dose of radiotherapy);
- 4. The presence of a Measurable lesions as defined by the RECIST 1.1 criteria, where a previously irradiated lesion shows definite progression after radiotherapy and where this previously irradiated lesion is not the only lesion;
- 5. 18-75 years of age or older; ECOG score: 0-1; expected survival ≥ 3 months.
- 6. Adequate hematology and organ function, i.e., the following criteria are met:
Show all 12Show fewer
- Hematology (no transfusion of blood or blood products within 14 days, not corrected with G-CSF and other hematopoietic stimulating factors): i. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (1,500/mm3); ii. Platelet count (PLT) ≥ 100 × 109/L (100,000 /mm3); iii. Hemoglobin (HB) ≥ 80 g/L.
- Renal: i. Creatinine clearance* (CrCl) calculated ≥ 50 mL/min; ii. Urine Protein < 2+ or 24 hour (h) urine protein quantification < 1.0 g.
- Liver: i. Serum total bilirubin (TBil) ≤ 1.5 × ULN; ii. AST and ALT ≤ 2.5 × ULN; iii. serum albumin (ALB) ≥ 28 g/L.
- Coagulation: i. International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN.
- Cardiac Function: i. Left Ventricular Ejection Fraction (LVEF) ≥ 50%.
- 7, Subjects voluntarily enrolled in this study and signed an informed consent form, complied well and cooperated with the follow-up.
Who cannot join
- 1, Patients with symptomatic brain metastases. Brain metastatic lesions that have been treated and kept in a clinically stable state of symptoms for at least 1 month, and do not use steroids and anticonvulsant drugs for at least 1 month prior to entering the study can be enrolled;
- 2. Previous use of anti-angiogenic drugs such as anlotinib, apatinib, bevacizumab, or related immunotherapeutic drugs targeting PD-1, PD-L1, etc.;
- 3. Those who have a wide range of factors affecting oral administration of the medication (e.g., the inability to swallow, After gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.);
- 4. Uncontrollable pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
- 5. Patients with imaging evidence of tumor invasion of important perivascular vessels, or patients who, in the judgment of the investigator, are at high risk of fatal hemorrhage due to tumor invasion of an important blood vessel during the follow-up period of the study;
- 6. Patients with a history of severe hemorrhagic tendency or coagulation dysfunction including, but not limited to, clinical symptoms within 3 months prior to entry into the study. Clinically significant hemoptysis (greater than one tablespoon of hemoptysis per day) within 3 months prior to enrollment; or clinically significant bleeding symptoms or bleeding tendency within 4 weeks prior to enrollment, such as peptic hemorrhage, hemorrhagic gastric ulcers (including gastrointestinal perforation and/or fistulae, except that gastrointestinal perforation or fistulae that have been surgically resected may be permitted to be enrolled), non-healing wounds, ulcers, or bone fracture;
Show all 10Show fewer
- 7. Patients who have received major Surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to enrollment;
- 8. Arterial/venous thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism, within 6 months prior to enrollment;
- 9. Active autoimmune disease requiring systemic therapy (e.g., palliative medications, corticosteroids, or immunosuppressants) within 2 years of the first dose;
- 10. Increased risk associated with participation in the study or study drug; and Other conditions that increase the risk associated with participation in the study or the study drug and, in the investigator's judgment, make the patient unsuitable for enrollment in the study;
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
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Minjiang Chen, +8601069155154, minjiangchen@163.com
About this study
Official title: A Real-world Study of Benmelstobart, Anlotinib and Chemotherapy Regimen as First-line Treatment for Extensive-stage Small-cell Lung Cancer
The goal of this clinical trial is to evaluate the efficacy and safety of benmelstobart in combination with anlotinib and chemotherapy sequential benmelstobart in combination with anlotinib for the first-line treatment of extensive-stage small cell lung cancer.
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Keywords
- small cell lung cancer, benmelstobart, anlotinib
- 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.
BenmelstobartDrug
Benmelstobart injection, 1200 mg/dose, given once every 21 days, intravenously.
AnlotinibDrug
Anlotinib hydrochloride capsules, 8 mg/dose, administered orally for 2 consecutive weeks and stopped for 1 week.
During the course of the study, subjects may be adjusted upward to a dose of 12 mg if well tolerated, as determined by the investigator, and the dose of anlotinib hydrochloride may be adjusted downward during the course of the study due to drug-related adverse events.
Carboplatin or cisplatinDrug
Carboplatin for injection, administered on day 1, AUC 5 mg/mL/min, intravenously (maximal dose used is 750 mg); or cisplatin administered on day 1, 75-80mg/m2, IV.
EtoposideDrug
Etoposide injection, 100mg/m2 on days 1, 2 and 3, IV.
| Study group | Role | What they receive |
|---|---|---|
| Benmelstobart in combination with anlotinib and chemotherapy | Experimental | Patients who met the enrollment criteria were first treated with benmelstobart in combination with anlotinib and carboplatin/cisplatin and etoposide for 4 cycles, and for non-progressing patients were evaluated by the investigator to receive maintenance therapy with benmelstobart in combination with anlotinib, which was continued until clinical benefit was lost or toxicity was intolerable or efficacy was evaluated to be PD, or continuation of the medication was deemed unsuitable by the investigator. Receives: Drug: Benmelstobart; Drug: Anlotinib; Drug: Carboplatin or cisplatin; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
The time from treatment to the first documented progressive disease (PD) assessed by the investigator according to RECIST 1.1 or death for any reason. Evaluated every 2 cycles/6 weeks on treatment and every 3 months in follow-up.
Measured: Approximately 7 months from treatment.
Secondary outcomes (5)
Overall Survival (OS)
The time from treatment to death due to any cause. Follow-up visits were made every 3 months after the end of treatment.
Measured: Approximately 14 months from treatment.
Objective Response Rate (ORR)
Percentage of participants who achieved Complete Response (CR) or Partial Response (PR), assessed by the investigator according to RECIST 1.1.
Measured: Approximately 12 weeks after the last participant begin study treatment.
Duration of Response (DOR)
The time from the first response (Complete Response (CR) or Partial Response (PR)) to disease progression (PD) assessed by the investigator according to RECIST 1.1 or death for any reason.
Measured: Approximately 7 months from treatment.
Disease Control Rate (DCR)
Percentage of participants who achieved Complete Response (CR), Partial Response (PR) or Stable Disease (SD), assessed by the investigator according to RECIST 1.1.
Measured: Approximately 12 weeks after the last participant begin study treatment.
Safety (Adverse Events (AEs))
Type and severity of adverse events according to CTCAE v5.0; calculation of the incidence of adverse events and their incidence by system.
Measured: From enrollment until 30 days after the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start15 Apr 2025 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Dec 2027 (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 Peking Union Medical College 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Responsible party
- Principal investigator, Wang mengzhao, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931145
- Sponsor's protocol ID
- K7820
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 23 Apr 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 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study of Benmelstobart, Anlotinib and Chemotherapy Regimen as First-line Treatment for Extensive-stage Small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06931145
- Acronym / sponsor ID
- K7820
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Keywords
- small cell lung cancer, benmelstobart, anlotinib
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Apr 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.
The goal of this clinical trial is to evaluate the efficacy and safety of benmelstobart in combination with anlotinib and chemotherapy sequential benmelstobart in combination with anlotinib for the first-line treatment of 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 |
|---|---|---|
| Benmelstobart in combination with anlotinib and chemotherapy | Experimental | Drug: Benmelstobart, Drug: Anlotinib, Drug: Carboplatin or cisplatin, Drug: EtoposidePatients who met the enrollment criteria were first treated with benmelstobart in combination with anlotinib and carboplatin/cisplatin and etoposide for 4 cycles, and for non-progressing patients were evaluated by the investigator to receive maintenance therapy with benmelstobart in combination with anlotinib, which was continued until clinical benefit was lost or toxicity was intolerable or efficacy was evaluated to be PD, or continuation of the medication was deemed unsuitable by the investigator. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Patients with pathologically confirmed extensive stage small cell lung cancer (VALG stage).
- 2. No prior systemic therapy for extensive-stage small cell lung cancer;
- 3. Patients who have received prior radiotherapy for limited-stage SCLC must have received radical therapy with a treatment-free interval of at least 6 months between the end of chemotherapy, radiotherapy, or radiochemotherapy and the diagnosis of extensive-stage SCLC (counting the time of completion of the last cycle of chemotherapy/time of completion of the last dose of radiotherapy);
- 4. The presence of a Measurable lesions as defined by the RECIST 1.1 criteria, where a previously irradiated lesion shows definite progression after radiotherapy and where this previously irradiated lesion is not the only lesion;
- 5. 18-75 years of age or older; ECOG score: 0-1; expected survival ≥ 3 months.
Key exclusion criteria (10 listed)
- 1, Patients with symptomatic brain metastases. Brain metastatic lesions that have been treated and kept in a clinically stable state of symptoms for at least 1 month, and do not use steroids and anticonvulsant drugs for at least 1 month prior to entering the study can be enrolled;
- 2. Previous use of anti-angiogenic drugs such as anlotinib, apatinib, bevacizumab, or related immunotherapeutic drugs targeting PD-1, PD-L1, etc.;
- 3. Those who have a wide range of factors affecting oral administration of the medication (e.g., the inability to swallow, After gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.);
- 4. Uncontrollable pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
- 5. Patients with imaging evidence of tumor invasion of important perivascular vessels, or patients who, in the judgment of the investigator, are at high risk of fatal hemorrhage due to tumor invasion of an important blood vessel during the follow-up period of the study;
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 |
|---|---|---|
| BenmelstobartBenmelstobart injection, 1200 mg/dose, given once every 21 days, intravenously. | Drug | Benmelstobart in combination with anlotinib and chemotherapy |
| AnlotinibAnlotinib hydrochloride capsules, 8 mg/dose, administered orally for 2 consecutive weeks and stopped for 1 week. During the course of the study, subjects may be adjusted upward to a dose of 12 mg if well tolerated, as determined by the investigator, and the dose of anlotinib hydrochloride may be adjusted downward during the course of the study due to drug-related adverse events. | Drug | Benmelstobart in combination with anlotinib and chemotherapy |
| Carboplatin or cisplatinCarboplatin for injection, administered on day 1, AUC 5 mg/mL/min, intravenously (maximal dose used is 750 mg); or cisplatin administered on day 1, 75-80mg/m2, IV. | Drug | Benmelstobart in combination with anlotinib and chemotherapy |
| EtoposideEtoposide injection, 100mg/m2 on days 1, 2 and 3, IV. | Drug | Benmelstobart in combination with anlotinib and chemotherapy |
Primary outcome
Progression Free Survival (PFS)
Time frame: Approximately 7 months from treatment.
The time from treatment to the first documented progressive disease (PD) assessed by the investigator according to RECIST 1.1 or death for any reason. Evaluated every 2 cycles/6 weeks on treatment and every 3 months in follow-up.
5 secondary outcomes
Overall Survival (OS)
Time frame: Approximately 14 months from treatment.
Objective Response Rate (ORR)
Time frame: Approximately 12 weeks after the last participant begin study treatment.
Duration of Response (DOR)
Time frame: Approximately 7 months from treatment.
Disease Control Rate (DCR)
Time frame: Approximately 12 weeks after the last participant begin study treatment.
Safety (Adverse Events (AEs))
Time frame: From enrollment until 30 days after the end of treatment.
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 23 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Extensive-stage Small Cell Lung Cancer
Active, not recruitingPhase 3
Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab
Extensive-Stage Small-Cell Lung Cancer, Small-Cell Lung Cancer
RecruitingPhase 2
A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
Extensive-stage Small-cell Lung Cancer
Active, not recruitingPhase 2
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
RecruitingPhase 2
MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer
Small Cell Lung Cancer, SCLC
Not yet recruitingPhase 2
Low-Dose Radiotherapy Plus Adebrelimab and Chemotherapy for Extensive-Stage Small Cell Lung Cancer
Small Cell Lung Cancer (SCLC), SCLC, Extensive Stage
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 4 study testing Benmelstobart, Anlotinib and Carboplatin or cisplatin in people with Extensive-stage Small Cell Lung Cancer, run by Peking Union Medical College 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 12 inclusion and 10 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 23 Apr 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: Approximately 7 months from treatment.). 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 23 Apr 2025.