Not yet taking people in ChinaPhase 2
SCTB41 plus docetaxel for previously treated advanced non-small cell lung cancer
Tests SCTB41 with docetaxel in adults whose non-small cell lung cancer was treated before.
Key facts
- Who runs it
- Sinocelltech Ltd.
- Where
- Wuhan, ChinaSee the site
- Trial code
- Registry title
- 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）
- Status
- Not yet recruiting
- Phase
- Phase 2
- People taking part
- 90 people, planned
- Started
- May 2026
- Expected to end
- Jul 2029
- Type of study
- Interventional
- Treatments tested
- SCTB41
- docetaxel
- Record updated
- 27 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic non-small cell lung cancer whose disease worsened after earlier treatment. They will receive SCTB41 with docetaxel.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer that cannot be fully removed by surgery and cannot be treated with chemoradiotherapy meant to remove all of the disease. At least one measurable lesion outside the brain.
- Earlier treatment
- Without an actionable gene change (AGA): disease worsened during or after PD-(L)1 inhibitor and chemotherapy. With AGA: adequate targeted therapy first. EGFR-positive people also need prior PD-(L)1/VEGF bispecific antibody and/or TROP-2 ADC. No prior docetaxel.
- Biomarker or test result
- Some people have an actionable gene change (AGA); EGFR-positive people have extra prior-treatment requirements.
Main reasons for not taking part
- Small cell carcinoma components in the tumour
- Symptomatic spread of cancer to the central nervous system
- Active autoimmune disease, active infection, tuberculosis, HIV, active hepatitis B or C, or syphilis
- Another cancer, or prior organ or stem cell transplant from a donor
- Pregnant or breastfeeding
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- 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
Who cannot take part
- Prior treatment with docetaxel
- Received the last dose of prior systemic anti-tumor therapy within 4 weeks before the first dose of study drug
- Severe infection, active infection, active tuberculosis, positive HIV antibody, active hepatitis B or hepatitis C, or known active syphilis prior to the first dose
- Prior history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
- 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
- History of non-infectious pneumonitis that required systemic corticosteroid therapy, or current presence of interstitial lung disease
- Known hypersensitivity to any component of the study drug; known hypersensitivity to taxanes; or history of severe hypersensitivity reaction to any other monoclonal antibody
- Any other condition that the investigator considers inappropriate for enrollment
- Histologically or cytologically confirmed presence of small cell carcinoma components
- Symptomatic central nervous system (CNS) metastases
- Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage
- Pregnant or breastfeeding women
Where in China
- Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & TechnologyWuhan, ChinaContact: Zhe HuangNo longer taking part
About the trial
What the trial wants to find out
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.
The group in the trial
- SCTB41+docetaxelTreatment being tested
Treatment: SCTB41 and docetaxel
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- SCTB41 plus docetaxel for previously treated advanced non-small cell lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 27 May 2026