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Not yet recruiting NCT07609251

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）

Phase II Interventional NSCLC (Advanced Non-small Cell Lung Cancer)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SCTB41, docetaxel.
Who it may be relevant to
Registry conditions: NSCLC (Advanced Non-small Cell Lung Cancer). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Frequency of adverse events (AEs) [Time frame: 24 months]
Secondary outcome measures (4)
  • Objective response rate (ORR) [Time frame: Up to 2 years]
  • Disease control rate (DCR) [Time frame: Up to 2 years]
  • Progression-free survival (PFS) [Time frame: Up to 2 years]
  • Overall survival (OS) [Time frame: Up to 2 years]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Any other condition that the investigator considers inappropriate for enrollment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & T — Wuhan

Identifiers

NCT: NCT07609251 · SCTB41-A302

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗