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）

A Phase II/III Study of SCTB41 Plus Docetaxel vs Placebo Plus Docetaxel in Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: NSCLC (Advanced Non-small Cell Lung Cancer)
• Intervention / Treatment: Drug: SCTB41; Drug: docetaxel

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
      • Contact: Zhe Huang; Phone Number: +86-010-58628288; Email: zhe_huang@sinocelltech.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SCTB41+docetaxel	Drug: SCTB41; SCTB41 is administered at selected dose by intravenous infusion on Day 1 of each 3-week cycle; Drug: docetaxel; docetaxel is administered at selected dose by intravenous infusion on Day 1 of each 3-week cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of adverse events (AEs)	To investigate the safety characteristics.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.	Up to 2 years
Overall survival (OS)	Overall survival is defined as the time from the start of treatment until death due to any cause.	Up to 2 years
Disease control rate (DCR)	The DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST Version 1.1.	Up to 2 years
Progression-free survival (PFS)	The PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first.	Up to 2 years

Collaborators and Investigators

• Sponsor: Sinocelltech Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: May 14, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Taxoids; Cyclodecanes; Diterpenes; Docetaxel
• Other Study ID Numbers: SCTB41-A302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No