Extensive-stage Small Cell Lung Cancer (ES-SCLC)Phase 2STAR-01NCT07501169
Sacituzumab Tirumotecan in Combination With Anlotinib in Previously Treated Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
A Phase 2 study testing Sacituzumab Tirumotecan and Anlotinib in people with Extensive-stage Small Cell Lung Cancer (ES-SCLC), run by Sichuan University at 1 site in China.
Trial summary
This is an single-arm, multicenter phase II study to evaluate the safety and efficacy of Sacituzumab Tirumotecan (sac-TMT) plus anlotinib in previously treated extensive-stage small cell lung cancer (ES-SCLC). The study is expected to enroll up to 33 eligible patients. 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 (ES-SCLC)
- 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
- 33 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 31 Dec 2028
- Phase
- Phase 2
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.Voluntary participation with written informed consent obtained prior to any study-specific procedures.
- 2.Age ≥ 18 years and ≤ 75 years, regardless of sex.
- 3.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 4.Life expectancy of at least 3 months.
- 5.Histologically or cytologically confirmed small cell lung cancer (SCLC) based on pathology and immunohistochemistry/immunophenotyping results; disease staged as extensive-stage SCLC (ES-SCLC) according to the Veterans Administration Lung Study Group (VALG) staging system.
- 6.Disease progression (at the time of enrollment) after at least two cycles of platinum-based systemic therapy with or without PD-1/L1 inhibitors; no more than two prior lines of therapy.
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- Note: Adjuvant therapy is considered one prior line if disease progression occurs during treatment or within 6 months of the last adjuvant dose.
- 7.At least one measurable lesion as defined by RECIST version 1.1. Lesions previously treated with local therapy may be considered target lesions only if progression has been clearly documented at that site post-treatment. Brain lesions as sole target lesions are not acceptable.
- 8.Adequate bone marrow function without transfusion or growth factor support within 14 days prior to screening: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L.
- 9.Adequate hepatic function: Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), or ≤ 2 × ULN for patients with Gilbert's syndrome; TBIL ≤ 3.0 × ULN is permitted if direct bilirubin suggests extrahepatic obstruction. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN (or ≤ 5 × ULN in the presence of liver metastases).
- 10.Adequate renal function: Creatinine (Cr) ≤ 1.5 × ULN and creatinine clearance (Ccr) ≥ 50 mL/min (calculated by Cockcroft-Gault formula or other clinically validated method).
- 11.Adequate coagulation function: Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; International normalized ratio (INR) ≤ 1.5 × ULN;
- 12.Adequate cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% assessed by echocardiography within 28 days prior to enrollment. New York Heart Association (NYHA) classification < 3.
- 13.Female patients of childbearing potential must agree to use medically effective contraception from the time of signing informed consent until 6 months after the last dose of study treatment.
Who cannot join
- 1.History of other primary malignancies within 5 years prior to signing informed consent, except for: radically treated malignancies with no recurrence within 5 years; adequately treated non-melanoma skin cancer, cervical carcinoma in situ, thyroid cancer, or other malignancies considered cured.
- 2.Prior pathological diagnosis of combined small cell lung cancer (e.g., mixed SCLC and NSCLC), transformed NSCLC (SCLC transformed to NSCLC), or transformed SCLC (NSCLC transformed to SCLC).
- 3.Prior anti-tumor therapy within specified washout periods before first study dose: chemotherapy, radiotherapy, biologics, endocrine therapy, immunotherapy within 4 weeks; topical anti-tumor agents within 5 half-lives; nitrosoureas or mitomycin C within 6 weeks; oral fluoropyrimidines or small-molecule targeted agents within 5 half-lives; anti-tumor traditional Chinese medicine within 2 weeks.
- 4.Treatment with any other investigational drug or therapy within 4 weeks prior to first study dose.
- 5.Prior or current use of topoisomerase I inhibitors, including antibody-drug conjugates with topoisomerase I inhibitor payloads (e.g., topotecan, irinotecan, trastuzumab deruxtecan, sacituzumab govitecan, datopotamab deruxtecan [DS-1062]).
- 6.Brain metastases unless asymptomatic (stable for ≥4 weeks, requiring ≤10 mg/day prednisone or equivalent for ≥14 days prior to first dose, and no significant peritumoral edema on imaging); leptomeningeal or brainstem metastases; spinal cord compression (radiographically confirmed, symptomatic or asymptomatic); bone marrow metastases.
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- 7.Imaging evidence of tumor lesions located ≤5 mm from major blood vessels, invading major vessels, or assessed by the investigator as having high risk of major bleeding during the study.
- 8.History of deep vein or arterial thromboembolic events within 6 months (e.g., cerebrovascular accident including TIA, deep vein thrombosis, pulmonary embolism); DVT adequately treated or superficial vein thrombosis with low bleeding risk per investigator may be enrolled.
- 9.Prior treatment-related toxicities (CTCAE v5.0) ≥ Grade 2, except for alopecia, residual neurotoxicity, or stable hypothyroidism on hormone replacement.
- 10.Major surgery (excluding biopsy or vascular access) or significant trauma within 4 weeks prior to first study dose, or planned elective surgery during the study period.
- 11.Receipt of live or live-attenuated vaccines within 4 weeks prior to first study dose.
- 12.Systemic corticosteroids (prednisone >10 mg/day or equivalent) or other immunosuppressive agents within 14 days prior to first study dose, except for: topical, ocular, intra-articular, intranasal, or inhaled corticosteroids; short-term corticosteroids for prophylaxis (e.g., contrast allergy).
- 13.History of non-infectious interstitial lung disease/pneumonitis requiring steroid maintenance (requiring 14-day washout), current ILD, or suspected ILD not ruled out by imaging at screening.
- 14.Active tuberculosis; active or uncontrolled autoimmune disease; acquired or congenital immunodeficiency disorders; history of allogeneic stem cell, bone marrow, or solid organ transplantation.
- 15.Serious infection within 4 weeks prior to first study dose, including but not limited to infection requiring systemic antibiotics, bacteremia, or severe pneumonia.
- 16.Positive serology results: HIV antibody positive; untreated active hepatitis B (HBsAg positive with HBV-DNA > ULN); Note: Patients meeting certain criteria may be enrolled with antiviral prophylaxis/monitoring; HCV-Ab positive with detectable HCV-RNA.
- 17.Significant cardiovascular disease history, including but not limited to: severe cardiac arrhythmia or conduction abnormalities (e.g., requiring intervention, Mobitz II or third-degree AV block); QTcF >450 ms (male) or >470 ms (female); congestive heart failure (NYHA class ≥II), unstable angina, acute coronary syndrome, aortic dissection, stroke or TIA within 6 months; deep vein thrombosis or pulmonary embolism within 6 months (excluding catheter-related or superficial thrombosis); uncontrolled hypertension (systolic >160 mmHg and/or diastolic >100 mmHg).
- 18.Clinically uncontrolled third-space fluid collections (e.g., pleural or ascitic effusion requiring intervention; patients with stable effusions >1 week post-drainage may enroll); pericardial effusion (asymptomatic minimal effusion not requiring intervention may enroll). If intra-cavity anti-tumor agents were used, a washout of ≥5 half-lives or 4 weeks (whichever is shorter) is required.
- 19.Known hypersensitivity or delayed allergic reaction to any component of the study drugs or comparators (e.g., topotecan, irinotecan, paclitaxel monotherapy).
- 20.Substance abuse, alcohol/drug dependence, or any medical condition (e.g., anxiety, depression) that may interfere with study participation or outcomes per investigator judgment.
- 21.Pregnant or breastfeeding women; men or women planning to conceive during the study.
- 22.Expected poor compliance, or any other severe systemic disease or condition that, in the investigator's opinion, makes the patient unsuitable for this study.
- 23.Bleeding diathesis (e.g., active peptic ulcer) or requirement for anticoagulants/vitamin K antagonists (e.g., warfarin, heparin); low-dose prophylactic warfarin (≤1 mg/d), heparin (≤12,000 U/d), or aspirin (≤100 mg/d) permitted if INR ≤1.5. Imaging evidence of tumor invasion, significant necrosis, or cavitation with high bleeding risk per investigator.
- 24.Any severe or uncontrolled systemic disease, including but not limited to: active tuberculosis/pulmonary fibrosis; active or uncontrolled infection requiring systemic therapy; clinically active diverticulitis, intra-abdominal abscess, GI obstruction; liver disease (e.g., cirrhosis, decompensated liver disease, acute/chronic hepatitis); poorly controlled diabetes (two consecutive FBG >10 mmol/L); urine protein ≥2+ confirmed by 24-hour urine protein >1.0 g; uncontrolled hypercalcemia (>1.5 mmol/L ionized calcium or >12 mg/dL calcium or corrected serum calcium >ULN) or symptomatic hypercalcemia requiring bisphosphonates; non-healing wounds or fractures; psychiatric disorders interfering with treatment compliance.
- 25.Factors affecting oral drug absorption (e.g., inability to swallow, post-, chronic diarrhea, intestinal obstruction).
- 26.Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or history of corneal disease affecting/delaying corneal healing.
- 27.Any other condition deemed unsuitable for participation by the investigator.
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
West China Hospital of Sichuan University
Sichuan, Chengdu, 610041
Jianxin Xue, 86-028-85423581, radjianxin@163.com
About this study
Official title: Sacituzumab Tirumotecan in Combination With Anlotinib in Previously Treated Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC): A Prospective, Single-Arm, Phase II Study (STAR-01)
This is an single-arm, multicenter phase II study to evaluate the safety and efficacy of Sacituzumab Tirumotecan (sac-TMT) plus anlotinib in previously treated extensive-stage small cell lung cancer (ES-SCLC). The study is expected to enroll up to 33 eligible patients.
Read the detailed description
Extensive-stage small cell lung cancer (ES-SCLC) is among the most aggressive lung cancer subtypes, with rapid progression and poor prognosis. Despite first-line immunotherapy plus chemotherapy improving outcomes, most patients relapse within one year and face limited options. Topotecan, the standard second-line therapy, yields only 10-20% ORR and median PFS of ~3 months. Therefore, identifying novel therapeutic strategies with improved efficacy in ES-SCLC represent an urgent unmet medical need.
Sacituzumab tirumotecan, a structurally optimized Trop-2-directed ADC, and anlotinib, a multi-target TKI inhibiting VEGFR, FGFR, and MET, offer complementary mechanisms of action. We hypothesize that their combination may synergistically overcome acquired resistance to chemotherapy and immunotherapy, providing a novel therapeutic strategy for previously treated ES-SCLC.
Eligible participants will receive Sacituzumab Tirumotecan (4mg/Kg intravenously on Day 1, Q2W) plus Anlotinib (8 mg orally once daily on Days 1-14, Q3W). The primary objective is Objective Response Rate (ORR), and the secondary objectives including but not limited Progression-Free Survival (PFS), Overall Survival (OS) and Disease control response (DCR) .
- Being tested
- Sacituzumab Tirumotecan and Anlotinib
- Keywords
- SCLC, Trop2-ADC, 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 Tirumotecan and AnlotinibDrug
Treatment with Sacituzumab Tirumotecan (4mg/kg IV d1 Q2W) and Anlotinib (8mg po d1-14 Q3W) until confirmed by the investigator as imaging disease progression, intolerable toxicity, subject's request to terminate treatment, or other treatment termination criteria specified in the protocol (based on the first patient). Drug reduction or dose regulation will be implemented according to the research plan.
| 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. The treatment will continue until disease progression, unacceptable toxic effects, withdrawal from the trial, or death or other protocol-defined discontinuation criteria are met, whichever occurred first. Receives: Drug: Sacituzumab Tirumotecan and Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.
Measured: 24 months
Secondary outcomes (7)
Progression Free Survival (PFS)
PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) by investigator assessment according to RECIST v1.1 or death from any cause, whichever comes first.
Measured: 24 months
Overall Survival (OS)
OS is defined as the time from randomization until the date of death from any cause.
Measured: 24 months
Disease control response (DCR)
DCR is defined as the proportion of participants who achieve a complete response (CR), partial response (PR) or or stable disease (SD) .
Measured: 24 months
Duration of response (DoR)
DoR is defined as the time from the first objective response (CR/PR) to the first documented disease progression (PD) according to RECIST v1.1 or death from any cause, whichever comes first.
Measured: 24 months
Progression-free survival (PFS) rate of 6 months
2.The 6-month PFS rate is defined as the proportion of patients who are progression-free and alive at 6 months, as assessed by the investigator per RECIST v1.1.
Measured: 6 months
Progression-free survival (PFS) rate of 1 year
The 1-year PFS rate is defined as the proportion of patients who are progression-free and alive at 1 year, as assessed by the investigator per RECIST v1.1.
Measured: 1 year
Incidence of Adverse Events
Number of participants with Investigator assessed treatment emergent adverse events per Common terminology criteria for adverse effects (CTCAE) version 5.0
Measured: From start of treatment through 60 days after last treatment, approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2028 (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 Cancer (ES-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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Collaborators
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Responsible party
- Principal investigator, You Lu, Sichuan University
- Investigators
- Jianxin Xue, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501169
- Sponsor's protocol ID
- HXIRB-2026-323
- Acronym
- STAR-01
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes