Small Cell Lung Cancer (SCLC)Phase 2NCT07358676
A Study of Bemotuzumab Plus Chemotherapy and Anlotinib Induction Followed by Bemotuzumab, Anlotinib and Consolidative Thoracic Radiotherapy in Extensive-Stage Small Cell Lung Cancer
A Phase 2 study testing Bemotuzumab + Anlotinib + Chemotherapy + Radiotherapy in people with Small Cell Lung Cancer (SCLC) and SCLC, Extensive Stage, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a phase II study evaluating a new combination therapy for untreated extensive-stage small cell lung cancer. The treatment involves an initial phase with the drug Bemotuzumab plus standard chemotherapy and anlotinib, followed by a phase combining Bemotuzumab, anlotinib, and chest radiation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer (SCLC), SCLC, Extensive Stage
- What is being tested?
- Bemotuzumab + Anlotinib + Chemotherapy + Radiotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 1 Jan 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
- Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) per VALG staging.
- No prior systemic therapy for ES-SCLC.
- At least one measurable lesion as defined by RECIST 1.1 criteria.
- Age 18-75 years.
- ECOG performance status of 0-2.
- Life expectancy of ≥3 months.
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- Adequate hematologic and organ function:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L.
- Platelet count ≥ 100 × 10^9/L.
- Hemoglobin ≥ 80 g/L.
- Creatinine clearance ≥ 50 mL/min.
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN).
- AST and ALT ≤ 2.5 × ULN.
- Albumin ≥ 28 g/L.
- INR and APTT ≤ 1.5 × ULN.
- Left ventricular ejection fraction (LVEF) ≥ 50%.
- For females of childbearing potential: negative serum pregnancy test within 3 days prior to dosing and agreement to use highly effective contraception.
- For males: agreement to use barrier contraception.
- Willing and able to provide written informed consent and comply with study procedures.
Who cannot join
- Symptomatic brain metastases. (Asymptomatic, treated, and stable brain metastases for ≥1 month without steroids are allowed).
- Prior thoracic radiotherapy for SCLC.
- Prior treatment with anti-angiogenic agents (e.g., anlotinib, bevacizumab) or anti-PD-1/PD-L1 therapies.
- Factors affecting oral medication intake (e.g., inability to swallow, major gastrointestinal resection).
- Uncontrolled effusions requiring repeated drainage (pleural, pericardial, or ascites).
- Imaging evidence of tumor invasion of major blood vessels or high risk of fatal hemorrhage as judged by the investigator.
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- History of significant bleeding tendency or coagulopathy, including clinically significant hemoptysis (>1 tablespoon daily within 3 months) or significant bleeding within 4 weeks prior to enrollment.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment.
- Arterial/venous thrombotic events within 6 months prior to enrollment (e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism).
- Active autoimmune disease requiring systemic treatment within 2 years prior to first dose.
- Any other condition that, in the investigator's judgment, increases risk or renders the patient unsuitable for 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, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300000
Ningbo Liu, Doctor, +8615602036608, liuningbo@tjmuch.com
About this study
Official title: An Exploratory Phase II Study of Bemotuzumab Combined With Chemotherapy and Anlotinib as Induction Therapy, Followed by Bemotuzumab, Anlotinib, and Consolidative Thoracic Radiotherapy in Patients With Extensive-Stage Small Cell Lung Cancer
This is a phase II study evaluating a new combination therapy for untreated extensive-stage small cell lung cancer. The treatment involves an initial phase with the drug Bemotuzumab plus standard chemotherapy and anlotinib, followed by a phase combining Bemotuzumab, anlotinib, and chest radiation. The primary objectives are to assess the efficacy of this approach in delaying cancer growth (progression-free survival) and to evaluate its safety in approximately 25 patients.
Read the detailed description
This is an exploratory Phase II clinical trial for previously untreated extensive-stage small cell lung cancer (ES-SCLC). The study evaluates a novel three-phase sequential treatment strategy: patients first receive induction therapy with Bemotuzumab combined with standard chemotherapy and Anlotinib; those achieving disease control then proceed to consolidation therapy with Bemotuzumab, Anlotinib, and concurrent thoracic radiotherapy; followed by a maintenance phase with Bemotuzumab plus Anlotinib. The primary objectives are to assess the regimen's efficacy in prolonging progression-free survival (PFS) and to observe its safety profile. The study plans to enroll approximately 25 patients.
- Being tested
- Bemotuzumab + Anlotinib + Chemotherapy + Radiotherapy
- Keywords
- Small Cell Lung Cancer (SCLC), bemotuzumab, anlotinib, hypofractionated radiotherapy, Induction therapy
- 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.
Bemotuzumab + Anlotinib + Chemotherapy + RadiotherapyCombination product
Also called Anlotinib Hydrochloride, Bemotuzumab Injection, Fucovee, Hypofractionated Radiotherapy
This is a multi-phase combined modality regimen.
Induction Phase (4 cycles): Bemotuzumab (1200mg IV, Day1 q3w) + Platinum/Etoposide chemotherapy (Carboplatin [AUC5] or Cisplatin [75-80 mg/m²] on Day1, plus Etoposide [100 mg/m² IV, Days1-3]) + oral Anlotinib (12mg, Days1-14, then 7 days off).
Consolidation Phase (2 cycles): Bemotuzumab (same dose) + Anlotinib (same schedule) + concurrent Thoracic Radiotherapy (5 Gy per fraction for 5 fractions).
Maintenance Phase: Bemotuzumab (q3w) + Anlotinib until disease progression or unacceptable toxicity.
Anlotinib Dose Modification: The dose may be increased to 12mg if well tolerated. For toxicity, it can be reduced sequentially (12mg→10mg→8mg). Treatment is discontinued if 8mg is not tolerated. For subjects at 8mg, one dose re-escalation is permitted if, in the investigator's judgement, clinical benefit is possible and safety is stable.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants receive a multi-phase experimental regimen. Induction (4 cycles, q3w): Bemotuzumab (1200 mg IV, Day 1) combined with investigator's choice of platinum-etoposide chemotherapy (Carboplatin AUC=5 or Cisplatin 75-80 mg/m² on Day 1, plus Etoposide 100 mg/m² IV on Days 1-3) and oral Anlotinib (12 mg once daily on Days 1-14, then 7 days off).
Consolidation (2 cycles, q3w): Bemotuzumab (same dose) + Anlotinib (same schedule) with concurrent hypofractionated thoracic radiotherapy (5 Gy per fraction for 5 fractions).
Maintenance: Bemotuzumab (q3w) + Anlotinib (same schedule) until disease progression, unacceptable toxicity, or other withdrawal criteria. Anlotinib dose may be reduced (12mg → 10mg → 8mg) for managing toxicity. Receives: Combination Product: Bemotuzumab + Anlotinib + Chemotherapy + Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS is defined as the time from enrollment to the first documented disease progression according to RECIST 1.1 criteria or death from any cause, whichever occurs first. Tumor assessments are performed every 6 weeks (every 2 treatment cycles).
Measured: From enrollment until disease progression or death from any cause, assessed up to approximately 24 months.
Secondary outcomes (3)
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who achieve a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by the investigator according to RECIST 1.1 criteria.
Measured: From enrollment until the first documented CR or PR, assessed up to approximately 24 months.
Overall Survival (OS)
OS is defined as the time from enrollment to death from any cause.
Measured: From enrollment until death from any cause, assessed up to approximately 24 months.
Incidence of Grade ≥3 Immune-Related Adverse Events (irAEs)
The incidence of treatment-emergent adverse events assessed as immune-related and graded ≥3 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Measured: From first dose of study drug until 28 days after the last dose, assessed up to approximately 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Feb 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Cell Lung Cancer (SCLC)Studies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- Model description
- This is a single-arm, exploratory study. All enrolled participants receive the same intervention sequence.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dingzhi Huang, Doctor, Principal investigator, Tianjin Medical University Cancer Institute and HospitalNingbo Liu, Doctor, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358676
- Sponsor's protocol ID
- E20260033
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
Zhou Y, Zhu H, Yang S, Liu J, Yu M, Sun J, Yang C, Cui Y, Liu N. Consolidation thoracic radiotherapy following quadruple induction with benmelstobart, anlotinib, and chemotherapy for extensive-stage small cell lung cancer: rationale and protocol of a phase II study. Transl Lung Cancer Res. 2026 Jun 30;15(6):181. doi: 10.21037/tlcr-2026-1-0114. Epub 2026 May 15.
PubMed 42433250
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Phase II Study of Bemotuzumab Combined With Chemotherapy and Anlotinib as Induction Therapy, Followed by Bemotuzumab, Anlotinib, and Consolidative Thoracic Radiotherapy in Patients With Extensive-Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07358676
- Acronym / sponsor ID
- E20260033
- Keywords
- Small Cell Lung Cancer (SCLC), bemotuzumab, anlotinib, hypofractionated radiotherapy, Induction therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 22 Jan 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.
This is a phase II study evaluating a new combination therapy for untreated extensive-stage small cell lung cancer. The treatment involves an initial phase with the drug Bemotuzumab plus standard chemotherapy and anlotinib, followed by a phase combining Bemotuzumab, anlotinib, and chest radiation. The primary objectives are to assess the efficacy of this approach in delaying cancer growth (progression-free survival) and to evaluate its safety in approximately 25 patients.
Detailed description
This is an exploratory Phase II clinical trial for previously untreated extensive-stage small cell lung cancer (ES-SCLC). The study evaluates a novel three-phase sequential treatment strategy: patients first receive induction therapy with Bemotuzumab combined with standard chemotherapy and Anlotinib; those achieving disease control then proceed to consolidation therapy with Bemotuzumab, Anlotinib, and concurrent thoracic radiotherapy; followed by a maintenance phase with Bemotuzumab plus Anlotinib. The primary objectives are to assess the regimen's efficacy in prolonging progression-free survival (PFS) and to observe its safety profile. The study plans to enroll approximately 25 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, exploratory study. All enrolled participants receive the same intervention sequence.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Combination Product: Bemotuzumab + Anlotinib + Chemotherapy + RadiotherapyParticipants receive a multi-phase experimental regimen. Induction (4 cycles, q3w): Bemotuzumab (1200 mg IV, Day 1) combined with investigator's choice of platinum-etoposide chemotherapy (Carboplatin AUC=5 or Cisplatin 75-80 mg/m² on Day 1, plus Etoposide 100 mg/m² IV on Days 1-3) and oral Anlotinib (12 mg once daily on Days 1-14, then 7 days off). Consolidation (2 cycles, q3w): Bemotuzumab (same dose) + Anlotinib (same schedule) with concurrent hypofractionated thoracic radiotherapy (5 Gy per fraction for 5 fractions). Maintenance: Bemotuzumab (q3w) + Anlotinib (same schedule) until disease progression, unacceptable toxicity, or other withdrawal criteria. Anlotinib dose may be reduced (12mg → 10mg → 8mg) for managing toxicity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) per VALG staging.
- No prior systemic therapy for ES-SCLC.
- At least one measurable lesion as defined by RECIST 1.1 criteria.
- Age 18-75 years.
- ECOG performance status of 0-2.
Key exclusion criteria (11 listed)
- Symptomatic brain metastases. (Asymptomatic, treated, and stable brain metastases for ≥1 month without steroids are allowed).
- Prior thoracic radiotherapy for SCLC.
- Prior treatment with anti-angiogenic agents (e.g., anlotinib, bevacizumab) or anti-PD-1/PD-L1 therapies.
- Factors affecting oral medication intake (e.g., inability to swallow, major gastrointestinal resection).
- Uncontrolled effusions requiring repeated drainage (pleural, pericardial, or ascites).
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 |
|---|---|---|
| Bemotuzumab + Anlotinib + Chemotherapy + RadiotherapyAlso: Anlotinib Hydrochloride, Bemotuzumab Injection, Fucovee, Hypofractionated RadiotherapyThis is a multi-phase combined modality regimen. Induction Phase (4 cycles): Bemotuzumab (1200mg IV, Day1 q3w) + Platinum/Etoposide chemotherapy (Carboplatin [AUC5] or Cisplatin [75-80 mg/m²] on Day1, plus Etoposide [100 mg/m² IV, Days1-3]) + oral Anlotinib (12mg, Days1-14, then 7 days off). Consolidation Phase (2 cycles): Bemotuzumab (same dose) + Anlotinib (same schedule) + concurrent Thoracic Radiotherapy (5 Gy per fraction for 5 fractions). Maintenance Phase: Bemotuzumab (q3w) + Anlotinib until disease progression or unacceptable toxicity. Anlotinib Dose Modification: The dose may be increased to 12mg if well tolerated. For toxicity, it can be reduced sequentially (12mg→10mg→8mg). Treatment is discontinued if 8mg is not tolerated. For subjects at 8mg, one dose re-escalation is permitted if, in the investigator's judgement, clinical benefit is possible and safety is stable. | Combination product | Experimental Group |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From enrollment until disease progression or death from any cause, assessed up to approximately 24 months.
PFS is defined as the time from enrollment to the first documented disease progression according to RECIST 1.1 criteria or death from any cause, whichever occurs first. Tumor assessments are performed every 6 weeks (every 2 treatment cycles).
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: From enrollment until the first documented CR or PR, assessed up to approximately 24 months.
Overall Survival (OS)
Time frame: From enrollment until death from any cause, assessed up to approximately 24 months.
Incidence of Grade ≥3 Immune-Related Adverse Events (irAEs)
Time frame: From first dose of study drug until 28 days after the last dose, assessed up to approximately 24 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 6 Jul 2026.
- Derived from this study: PubMed 42433250Zhou Y, Zhu H, Yang S, Liu J, Yu M, Sun J, Yang C, Cui Y, Liu N. Consolidation thoracic radiotherapy following quadruple induction with benmelstobart, anlotinib, and chemotherapy for extensive-stage small cell lung cancer: rationale and protocol of a phase II study. Transl Lung Cancer Res. 2026 Jun 30;15(6):181. doi: 10.21037/tlcr-2026-1-0114. Epub 2026 May 15.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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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.
Dingzhi Huang, Doctor principal investigator
Tianjin Medical University Cancer Institute and Hospital
Ningbo Liu, Doctor principal investigator
Tianjin Medical University Cancer Institute and Hospital
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 Bemotuzumab + Anlotinib + Chemotherapy + Radiotherapy in people with Small Cell Lung Cancer (SCLC) and SCLC, Extensive Stage, run by Tianjin Medical University Cancer Institute and 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 19 inclusion and 11 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 6 Jul 2026. 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 Dingzhi Huang, Doctor (86-22-23340123 ext. 3200, dingzhih72@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 (PFS) (time frame: From enrollment until disease progression or death from any cause, assessed up to approximately 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07358676, which also lists 1 linked publication.
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 6 Jul 2026.