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Clinical Trials in China / NCT07609251
Starting soon Phase 2

A Clinical Study of SCTB41 Combined With Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer(Phase II Study Ongoing)

NCT07609251 · tracked via the Priya Life Science China tracker
Sponsor
Sinocelltech Ltd.
Phase
Phase 2
Started
2026-05
Last updated
2026-05-27

Condition(s) studied

NSCLC (Advanced Non-small Cell Lung Cancer)

Investigational drug(s) / intervention(s)

SCTB41 →docetaxel →

SCTB41: SCTB41 is administered at selected dose by intravenous infusion on Day 1 of each 3-week cycle

docetaxel: docetaxel is administered at selected dose by intravenous infusion on Day 1 of each 3-week cycle

Study summary

This study aims to evaluate the safety and efficacy of SCTB41 combined with docetaxel in patients with previously treated non-small cell lung cancer. The Phase II part of this study is an open-label, multicenter clinical trial.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Voluntarily sign the informed consent form (ICF); 2. ECOG 0-1; 3. Survival duration more than 3 months; 4. Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) that is not amenable to complete surgical resection and cannot receive curative concurrent/sequential chemoradiotherapy; 5. Without AGA: Have experienced disease progression during or after prior treatment with PD-(L)1 inhibitors and chemotherapy.With AGA: Must have received adequate targeted therapy; EGFR-positive patients must have received prior treatment with PD-(L)1/VEGF bispecific antibody and/or TROP-2 ADC; 6. At least one measurable non-brain lesion according to RECIST v1.1; 7. Adequate major organ function. Exclusion Criteria: 1. Histologically or cytologically confirmed presence of small cell carcinoma components; 2. Prior treatment with docetaxel; 3. Symptomatic central nervous system (CNS) metastases; 4. Received the last dose of prior systemic anti-tumor therapy within 4 weeks before the first dose of study drug; 5. Imaging findings at screening show tumor invasion into major blood vessels or surrounding vital organs, or the presence of a risk of esophagotracheal or esophagopleural fistula, which the investigator assesses as unsuitable for enrollment; 6. History of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension despite medical therapy; 7. Presence of any active autoimmune disease or history of autoimmune disease with anticipated risk of relapse; 8. Bleeding tendency, high risk of bleeding, or coagulation disorders; 9. Diagnosis of another malignancy; 10. Severe infection, active infection, active tuberculosis, positive HIV antibody, active hepatitis B or hepatitis C, or known active syphilis prior to the first dose; 11. Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 12. History of non-infectious pneumonitis that required systemic corticosteroid therapy, or current presence of interstitial lung disease; 13. Prior history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 14. Known hypersensitivity to any component of the study drug; known hypersensitivity to taxanes; or history of severe hypersensitivity reaction to any other monoclonal antibody; 15. Pregnant or breastfeeding women; 16. Any other condition that the investigator considers inappropriate for enrollment.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology Wuhan Hubei

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07609251 on ClinicalTrials.gov ↗ ← All trials in China