Sacituzumab Tirumotecan Plus Anlotinib in Previously Treated ES-SCLC

NCT07388875 | Not Yet Recruiting Phase 2

• 1 other identifier: CLOG2601
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Extensive-Stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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).

  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)

  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)

  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.

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. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria are met.

Drug: Sacituzumab Tirumotecan; Drug: Anlotinib

Interventions

Sacituzumab Tirumotecan DRUG

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.

Experimental Arm

Anlotinib DRUG

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.

Experimental Arm

Eligibility Criteria

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

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• China Medical University, China: lead

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

Central Study Contacts

Lingyun Zhang

CONTACT

024-83281802; zhangliy1105@126.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: Professor

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 5, 2026
• Study Start: February 24, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share