Sacituzumab Tirumotecan in Combination With Anlotinib in Previously Treated Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

NCT07501169 | Not Yet Recruiting Phase 2

• 1 other identifier: HXIRB-2026-323
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Extensive-stage Small Cell Lung Cancer (ES-SCLC)

Keywords

SCLC; Trop2-ADC; Anlotinib

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (7)

• Progression Free Survival (PFS)

  24 months

• Overall Survival (OS)

  24 months

• Disease control response (DCR)

  24 months

• Duration of response (DoR)

  24 months

• Progression-free survival (PFS) rate of 6 months

  6 months

Other Outcomes (1)

• Trop2 expression.

  24 months

Study Arms (1)

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.

Drug: Sacituzumab Tirumotecan and Anlotinib

Interventions

Sacituzumab Tirumotecan and Anlotinib DRUG

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.

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation with written informed consent obtained prior to any study-specific procedures.
• Age ≥ 18 years and ≤ 75 years, regardless of sex.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy of at least 3 months.
• 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.
• 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.
• Note: Adjuvant therapy is considered one prior line if disease progression occurs during treatment or within 6 months of the last adjuvant dose.
• 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.
• 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.
• 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).
• 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).
• Adequate coagulation function: Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; International normalized ratio (INR) ≤ 1.5 × ULN;
• 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.
• 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.

You may not qualify if:

• 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.
• 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).
• 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.
• Treatment with any other investigational drug or therapy within 4 weeks prior to first study dose.
• 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 \[DS-1062\]).
• 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.
• 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.
• 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.
• Prior treatment-related toxicities (CTCAE v5.0) ≥ Grade 2, except for alopecia, residual neurotoxicity, or stable hypothyroidism on hormone replacement.
• 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.
• Receipt of live or live-attenuated vaccines within 4 weeks prior to first study dose.
• 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).
• 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.
• Active tuberculosis; active or uncontrolled autoimmune disease; acquired or congenital immunodeficiency disorders; history of allogeneic stem cell, bone marrow, or solid organ transplantation.
• Serious infection within 4 weeks prior to first study dose, including but not limited to infection requiring systemic antibiotics, bacteremia, or severe pneumonia.

Sponsors & Collaborators

• Sichuan University: lead
• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.: collaborator
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (1)

West China Hospital of Sichuan University

Sichuan, Chengdu, 610041, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jianxin Xue

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JianXin Xue

CONTACT

86-028-85423581; radjianxin@163.com

You Lu

CONTACT

+86 189 8060 1763; radyoulu@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Thoracic Cancer Ward

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CN (1)