Extensive-Stage Small Cell Lung CancerPhase 2SKB264-ANLONCT07388875
Sacituzumab Tirumotecan Plus Anlotinib in Previously Treated ES-SCLC
A Phase 2 study testing Sacituzumab Tirumotecan and Anlotinib in people with Extensive-Stage Small Cell Lung Cancer, run by China Medical University, China.
Trial summary
This is a Phase II, single-arm, open-label clinical study to evaluate the efficacy and safety of Sacituzumab Tirumotecan (SKB264) combined with Anlotinib in patients with extensive-stage small cell lung cancer (ES-SCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-Stage Small Cell Lung Cancer
- What is being tested?
- Sacituzumab Tirumotecan and Anlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 24 Feb 2026to 1 Aug 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years at the time of signing informed consent; male or female.
- Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
- Disease progression after receiving only one prior line of therapy consisting of a PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy.
- At least one measurable target lesion per RECIST v1.1 as assessed by the investigator, which has not been previously irradiated.
- Patients with asymptomatic brain metastases, or patients with treated brain metastases and stable symptoms for ≥4 weeks, are eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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- Estimated life expectancy of at least 12 weeks.
- Adequate organ and bone marrow function (no blood transfusion, recombinant human thrombopoietin, or colony-stimulating factors within 2 weeks prior to first dose), defined as follows:
- Hematologic function:
- Absolute neutrophil count ≥1.5 × 10⁹/L
- Platelet count ≥100 × 10⁹/L
- Hemoglobin ≥90 g/L
- Hepatic function:
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN; for patients with liver metastases, AST and ALT ≤5 × ULN
- Albumin ≥30 g/L
- Total bilirubin ≤1.5 × ULN
- Renal function:
- Creatinine clearance ≥50 mL/min, calculated using the Cockcroft-Gault formula
- Coagulation function:
- International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) ≤1.5 × ULN
- Women of childbearing potential and men with partners of childbearing potential must agree to use effective medical contraception from signing informed consent until 6 months after the last dose of study treatment.
- Subjects must voluntarily participate in the study, provide written informed consent, and be able to comply with protocol-required visits and study procedures.
Who cannot join
- Participation in another interventional drug clinical trial within 4 weeks prior to enrollment.
- Tumors with a high risk of massive hemoptysis, as judged by the investigator.
- Prior systemic anti-tumor therapy with anti-angiogenic agents.
- Prior treatment with TROP2-targeted therapies and/or topoisomerase I inhibitors.
- History of other malignancies within the past 5 years, except for adequately treated cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin.
- Known hypersensitivity or allergy to any investigational product or its components.
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- Known positive human immunodeficiency virus (HIV) infection, history of acquired immunodeficiency syndrome (AIDS), or known active syphilis infection.
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Receipt of live vaccines within 30 days prior to the first dose of study treatment.
- History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment; current ILD or non-infectious pneumonitis; or suspected ILD or non-infectious pneumonitis that cannot be excluded by imaging at screening. Severe pulmonary impairment due to pulmonary comorbidities, including but not limited to:
- Pulmonary embolism within 3 months prior to first dose
- Severe asthma
- Severe chronic obstructive pulmonary disease
- Restrictive lung disease
- Pleural effusion
- Autoimmune, connective tissue, or inflammatory diseases involving the lungs (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis)
- Prior pneumonectomy
- Active autoimmune disease requiring systemic treatment within the past 2 years (hormone replacement therapy is not considered systemic treatment, such as type 1 diabetes mellitus, hypothyroidism requiring only thyroid hormone replacement, or adrenal or pituitary insufficiency requiring physiologic doses of corticosteroids).
- Active infection requiring systemic therapy within 2 weeks prior to the first dose of study treatment.
- Serious concomitant diseases that, in the investigator's judgment, may compromise patient safety or interfere with completion of the study, including but not limited to uncontrolled hypertension, severe diabetes mellitus, or active infection.
- Documented severe dry eye syndrome, severe meibomian gland dysfunction and/or blepharitis, or a history of corneal disorders that may interfere with delayed corneal healing.
- Pregnant or breastfeeding women; women of childbearing potential with a positive baseline pregnancy test; or women of childbearing potential who are unwilling to use effective contraception during study treatment and for 6 months after the last dose of study treatment.
- Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in 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
Official title: A Single-arm, Phase II Study of Sacituzumab Tirumotecan Combined With Anlotinib in Patients With Extensive-stage Small Cell Lung Cancer After Failure of PD-(L)1 Inhibitor Plus Chemotherapy
This is a Phase II, single-arm, open-label clinical study to evaluate the efficacy and safety of Sacituzumab Tirumotecan (SKB264) combined with Anlotinib in patients with extensive-stage small cell lung cancer (ES-SCLC). The study is designed for patients who have experienced disease progression or treatment failure after prior first-line therapy with a PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy. The primary hypothesis is that this combination therapy will improve the objective response rate compared to historical controls.
Read the detailed description
Small cell lung cancer (SCLC) is an aggressive malignancy with a poor prognosis. While chemotherapy combined with immunotherapy is the standard first-line treatment for extensive-stage SCLC (ES-SCLC), therapeutic options remain limited for patients who progress after this initial therapy. There is an urgent need to explore new treatment strategies to extend patient survival.
Sacituzumab Tirumotecan (SKB264) is a humanized antibody-drug conjugate (ADC) targeting TROP2, which is often overexpressed in SCLC. It works by delivering a topoisomerase I inhibitor directly to tumor cells. Anlotinib is a multi-target tyrosine kinase inhibitor that suppresses tumor angiogenesis and proliferation.
This study investigates the potential synergistic effect of combining SKB264 with Anlotinib. The rationale is that anti-angiogenic therapy (Anlotinib) may normalize tumor vasculature, thereby enhancing the delivery and efficacy of the ADC (SKB264) within the tumor microenvironment.
Eligible participants will receive Sacituzumab Tirumotecan (200 mg intravenously on Day 1 of each 3-week cycle) combined with Anlotinib (8 mg orally once daily on Days 1-14 of each 3-week cycle). The study utilizes a Simon's two-stage minimax design to assess the Objective Response Rate (ORR) as the primary endpoint. Secondary objectives include evaluating Progression-Free Survival (PFS), Overall Survival (OS), and the safety profile of the combination.
- Conditions
- Extensive-Stage Small Cell Lung Cancer
- Being tested
- Sacituzumab Tirumotecan, 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.
Sacituzumab TirumotecanDrug
Sacituzumab tirumotecan is an antibody-drug conjugate targeting Trop-2. It will be administered intravenously according to the dosing schedule specified in the study protocol. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria are met.
AnlotinibDrug
Anlotinib is an oral small-molecule multi-target tyrosine kinase inhibitor. It will be administered orally according to the dosing regimen specified in the study protocol. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria are met.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Participants will receive sacituzumab tirumotecan in combination with anlotinib. Sacituzumab tirumotecan will be administered intravenously, and anlotinib will be administered orally, according to the dosing schedule specified in the study protocol. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria are met. Receives: Drug: Sacituzumab Tirumotecan; Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Objective response rate (ORR) as assessed by the investigator according to RECIST version 1.1, defined as the proportion of patients achieving complete response (CR) or partial response (PR).
Measured: From the first dose of study treatment until disease progression, intolerance, or start of new anti-cancer therapy, assessed every 6 weeks for the first 12 months and every 12 weeks thereafter, up to approximately 24 months.
Secondary outcomes (2)
Progression-Free Survival (PFS)
The time from the first dose of study treatment to the first documented disease progression or death from any cause.
Measured: From the first dose of study treatment until disease progression, intolerance, or start of new anti-cancer therapy, assessed every 6 weeks for the first 12 months and every 12 weeks thereafter, up to approximately 24 months
Overall Survival (OS)
The time from randomization (or first dose) to death from any cause.
Measured: From first dose until death, assessed every 6 weeks (Year 1) then every 12 weeks, and every 3 months during survival follow-up, 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 posted5 Feb 2026
- Study start24 Feb 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Aug 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.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiujuan Qu, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388875
- Sponsor's protocol ID
- CLOG2601
- Acronym
- SKB264-ANLO
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study is ongoing and the data are considered confidential. Data sharing may be considered after study completion upon reasonable request and approval by the sponsor.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Phase II Study of Sacituzumab Tirumotecan Combined With Anlotinib in Patients With Extensive-stage Small Cell Lung Cancer After Failure of PD-(L)1 Inhibitor Plus Chemotherapy
- ClinicalTrials.gov ID
- NCT07388875
- Acronym / sponsor ID
- SKB264-ANLO / CLOG2601
- Conditions
- Extensive-Stage Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 24 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 5 Feb 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, single-arm, open-label clinical study to evaluate the efficacy and safety of Sacituzumab Tirumotecan (SKB264) combined with Anlotinib in patients with extensive-stage small cell lung cancer (ES-SCLC). The study is designed for patients who have experienced disease progression or treatment failure after prior first-line therapy with a PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy. The primary hypothesis is that this combination therapy will improve the objective response rate compared to historical controls.
Detailed description
Small cell lung cancer (SCLC) is an aggressive malignancy with a poor prognosis. While chemotherapy combined with immunotherapy is the standard first-line treatment for extensive-stage SCLC (ES-SCLC), therapeutic options remain limited for patients who progress after this initial therapy. There is an urgent need to explore new treatment strategies to extend patient survival.
Sacituzumab Tirumotecan (SKB264) is a humanized antibody-drug conjugate (ADC) targeting TROP2, which is often overexpressed in SCLC. It works by delivering a topoisomerase I inhibitor directly to tumor cells. Anlotinib is a multi-target tyrosine kinase inhibitor that suppresses tumor angiogenesis and proliferation.
This study investigates the potential synergistic effect of combining SKB264 with Anlotinib. The rationale is that anti-angiogenic therapy (Anlotinib) may normalize tumor vasculature, thereby enhancing the delivery and efficacy of the ADC (SKB264) within the tumor microenvironment.
Eligible participants will receive Sacituzumab Tirumotecan (200 mg intravenously on Day 1 of each 3-week cycle) combined with Anlotinib (8 mg orally once daily on Days 1-14 of each 3-week cycle). The study utilizes a Simon's two-stage minimax design to assess the Objective Response Rate (ORR) as the primary endpoint. Secondary objectives include evaluating Progression-Free Survival (PFS), Overall Survival (OS), and the safety profile of the combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Sacituzumab Tirumotecan, Drug: AnlotinibParticipants will receive sacituzumab tirumotecan in combination with anlotinib. Sacituzumab tirumotecan will be administered intravenously, and anlotinib will be administered orally, according to the dosing schedule specified in the study protocol. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria are met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age ≥18 years at the time of signing informed consent; male or female.
- Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
- Disease progression after receiving only one prior line of therapy consisting of a PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy.
- At least one measurable target lesion per RECIST v1.1 as assessed by the investigator, which has not been previously irradiated.
- Patients with asymptomatic brain metastases, or patients with treated brain metastases and stable symptoms for ≥4 weeks, are eligible.
Key exclusion criteria (23 listed)
- Participation in another interventional drug clinical trial within 4 weeks prior to enrollment.
- Tumors with a high risk of massive hemoptysis, as judged by the investigator.
- Prior systemic anti-tumor therapy with anti-angiogenic agents.
- Prior treatment with TROP2-targeted therapies and/or topoisomerase I inhibitors.
- History of other malignancies within the past 5 years, except for adequately treated cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin.
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 |
|---|---|---|
| Sacituzumab TirumotecanSacituzumab tirumotecan is an antibody-drug conjugate targeting Trop-2. It will be administered intravenously according to the dosing schedule specified in the study protocol. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria are met. | Drug | Experimental Arm |
| AnlotinibAnlotinib is an oral small-molecule multi-target tyrosine kinase inhibitor. It will be administered orally according to the dosing regimen specified in the study protocol. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria are met. | Drug | Experimental Arm |
Primary outcome
Objective Response Rate (ORR)
Time frame: From the first dose of study treatment until disease progression, intolerance, or start of new anti-cancer therapy, assessed every 6 weeks for the first 12 months and every 12 weeks thereafter, up to approximately 24 months.
Objective response rate (ORR) as assessed by the investigator according to RECIST version 1.1, defined as the proportion of patients achieving complete response (CR) or partial response (PR).
2 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From the first dose of study treatment until disease progression, intolerance, or start of new anti-cancer therapy, assessed every 6 weeks for the first 12 months and every 12 weeks thereafter, up to approximately 24 months
Overall Survival (OS)
Time frame: From first dose until death, assessed every 6 weeks (Year 1) then every 12 weeks, and every 3 months during survival follow-up, 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 5 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study is ongoing and the data are considered confidential. Data sharing may be considered after study completion upon reasonable request and approval by the sponsor.
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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 2 study testing Sacituzumab Tirumotecan and Anlotinib in people with Extensive-Stage Small Cell Lung Cancer, run by China Medical University, 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 22 inclusion and 23 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 5 Feb 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 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 Lingyun Zhang (024-83281802, zhangliy1105@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From the first dose of study treatment until disease progression, intolerance, or start of new anti-cancer therapy, assessed every 6 weeks for the first 12 months and every 12 weeks thereafter, 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?
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 5 Feb 2026.