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 | Not Yet Recruiting Phase 2

• 1 other identifier: SCTB41-A302
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer)

Outcome Measures

Primary Outcomes (1)

• Frequency of adverse events (AEs)

  To investigate the safety characteristics.

  24 months

Secondary Outcomes (4)

• Objective response rate (ORR)

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

• Progression-free survival (PFS)

  Up to 2 years

• Overall survival (OS)

  Up to 2 years

Study Arms (1)

SCTB41+docetaxel

EXPERIMENTAL

Drug: SCTB41; Drug: docetaxel

Interventions

SCTB41 DRUG

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

SCTB41+docetaxel

docetaxel DRUG

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

SCTB41+docetaxel

Eligibility Criteria

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

You may qualify if:

• Voluntarily sign the informed consent form (ICF);
• ECOG 0-1;
• Survival duration more than 3 months;
• 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;
• 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;
• At least one measurable non-brain lesion according to RECIST v1.1;
• Adequate major organ function.

You may not qualify if:

• Histologically or cytologically confirmed presence of small cell carcinoma components;
• Prior treatment with docetaxel;
• Symptomatic central nervous system (CNS) metastases;
• Received the last dose of prior systemic anti-tumor therapy within 4 weeks before the first dose of study drug;
• 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;
• History of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension despite medical therapy;
• Presence of any active autoimmune disease or history of autoimmune disease with anticipated risk of relapse;
• Bleeding tendency, high risk of bleeding, or coagulation disorders;
• Diagnosis of another malignancy;
• Severe infection, active infection, active tuberculosis, positive HIV antibody, active hepatitis B or hepatitis C, or known active syphilis prior to the first dose;
• Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
• History of non-infectious pneumonitis that required systemic corticosteroid therapy, or current presence of interstitial lung disease;
• Prior history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Known hypersensitivity to any component of the study drug; known hypersensitivity to taxanes; or history of severe hypersensitivity reaction to any other monoclonal antibody;
• Pregnant or breastfeeding women;

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)