Clinical trial · Interventional
Recombinant Endostatin Combined With Vinorelbine and Cisplatin in Patients With Advanced Non-small Cell Lung Cancer
Recombinant Endostatin With Vinorelbine and Cisplatin (NP) Plus Maintenance Therapy With Recombinant Endostatin for Advanced Non-small Cell Lung Cancer: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study
- 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 main object of this trial is to offer treatment of recombinant endostatin ( Sulijia) combined with Vinorelbine and Cisplatin (NP) plus maintenance therapy with Sulijia for advanced Non-small Cell Lung Cancer, expecting to improve progression free survival (PFS) , disease control rate(DCR) , objective response rate(ORR) and Overall survival (OS) compared with chemotherapy alone, and evaluate the efficacy and safety of Sulijia.
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 |
|---|---|---|---|
| Advanced Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebos | Drug | — | UNRESOLVED |
| Sulijia | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Vinorelbine plus Cisplatin With placebos
- description
- The control group
- interventionNames
- Drug: Placebos
- type
- EXPERIMENTAL
- label
- Vinorelbine plus Cisplatin With Sulijia
- description
- The treatment group
- interventionNames
- Drug: Sulijia
Primary outcomes (1)
- measure
- Progression Free Survival(PFS)
- timeFrame
- Assessed up to 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male and female aged 18 to 70 years old; 2. Patients with histological confirmed stage IV NSCLC; 3. According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter \>=10mm by spiral CT, PET-CT, with the largest diameter \>=20mm by ordinary CT and MRI; 4. general condition ECOG performance scale (PS) 0-1; 5. Life expectancy of more than 3 months; 6. No major organ dysfunction and laboratory indicators should meet the following requirements: absolute neutrophil count \> 1.5\*10\^9/L, platelet count\> 90\*10\^9/L, hemoglobin\> 9g/dL; liver function: serum bilirubin was less than 2\* maximum normal value; ALT and AST were less than 2.5\*maximum normal value; BUN, Cr within 80% of normal range; 7. Patients could understand the circumstances of this study and those who have signed the informed consent form. Exclusion Criteria: 1. Receive the treatment of other experimental trials in the same period; on the medication of other anticancer drugs at the same time; 2. Patients who have uncontrolled brain metastasis; 3. Suffered from any other malignant tumors in the five years except for complete cure of cervical carcinoma in situ, basal cell cancer; 4. Pregnant or lactating women; 5. Severe infected patients; 6. Patients who have serious cardiovascular disease such as coronary heart disease, unstable cardiac angina and high blood pressure; 7. Patients who have vein thrombus; 8. Patients who have psychiatric illness; 9. Patients who are allergic to E. coli preparation; 10. Researchers believe that those who do not fit.
References
Publications (0)
Data not yet available