Clinical trial · Interventional
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
NCT07609251CI-TRIAL-00112670not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC (Advanced Non-small Cell Lung Cancer) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| SCTB41 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SCTB41+docetaxel
- interventionNames
- Drug: SCTB41
- Drug: docetaxel
Primary outcomes (1)
- measure
- Frequency of adverse events (AEs)
- timeFrame
- 24 months
- description
- To investigate the safety characteristics.
Secondary outcomes (4)
- measure
- Objective response rate (ORR)
- timeFrame
- Up to 2 years
- description
- The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.