Clinical trial · Interventional
Investigation of Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Non-small Cell Lung Cancer
Phase Ⅱa,Open Label,Multicenter Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Non-small Cell Lung Cancer
NCT01305967CI-TRIAL-00004490unknownPhase 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)
The purpose of this study is to determine efficacy of SB injection in Non Small Cell Lung Cancer.
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 |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SB injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall Best Response Rate
- timeFrame
- 2.5 months
Secondary outcomes (3)
- measure
- Determine duration of response rate by measuring time to progression
- timeFrame
- 2.5 months
- measure
- Pain Scores on the Visual Analog Scale
- timeFrame
- 2.5months
- measure
- Evalute patient's performance by measuring the Eastern Cooperative Oncology Group scale
- timeFrame
- 2.5months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age of 18-70 years * Patients with histologically or cytologically confirmed Non-Small Cell Lung Cancer * Patients who had failed more than 1 cycle of standard therapy with advanced or metasatic stage not available to any of resectable surgery or radiotherapy. * Patients with measurable lesions * Eatern Cooperative Oncolgy Group status 0 to 2. * Life expectancy \>/= 5 months * Patients with adequate organ(heart, kidney, liver)and bone marrow function, as defined by 1. Absolute neutrophil count \>/= 1.5 x 10\^9/L, Platelet count \>/= 100 x 10\^9/L 2. Total bilirubin \</= upper limit of normal 3. Aspartate Aminotransferase and/or Alanine Aminotransferase \</= 2 x upeer limit of normal 4. creatinine \</= 1.5 x upeer limit of normal * Patients who have signed the informed consent form. Exclusion Criteria: * Female volunteers admitted to the study must be using a reliable means of contraception * Received radiation therapy within 6 weeks before randomization * Known brain or spinal cord metastases * Have acute infection * Have active infection or serious concomitant systemic disorder incompatible with the study * Presence or history of malignancy other than Non-Small Cell Lung Cancer * Have severe neurologic or psychological disorder * Patients who have to receive other chemo-radiotherapy or immunotherapy * Patients who have received chemotherapy within the previous 30 days * Patients who are candidates for combined modality treatment. * Patients who have participated in a clinical study within the previous 30 days
References
Publications (0)
Data not yet available
No reference posted for this study.