Clinical trial · Interventional
Rh-Endostatin (Endostar®) Continuous Intravenous Infusion
The Safety and Efficacy of Rh-Endostatin (Endostar®) Continuous Intravenous Infusion in Combination With Docetaxel/Carboplatin or Pemetrexed/Carboplatin (DC/PC) Regimens for Untreated Stage IIIB/IV Non-small-cell Lung Cancer (NSCLC)
- 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)
Endostar is a anti-angiogenesis product and has been launched in China . The efficacy and safety have been defined. However, the compliance is unsatisfactory since routine i.v of Endostar is needed for 3 to 4 hours daily during one cycle of 14 days. The continuous intravenous infusion by using venous pump can improve the compliance.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Endostar | Drug | — | UNRESOLVED |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endostar continuous intravenous infusion
- description
- Endostar continuous intravenous infusion in combination with docetaxel/carboplatin or pemetrexed/carboplatin
- interventionNames
- Drug: Endostar
- Drug: Docetaxel
- Drug: Carboplatin
- Drug: Pemetrexed
Primary outcomes (1)
- measure
- ORR
- timeFrame
- 8 weeks
- description
- objective response rate based on Recist 1.1 edition
Secondary outcomes (1)
- measure
- PFS
- timeFrame
- 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion criteria: Primary non-small cell lung cancer confirmed by cytology and histology, excluding sputum examination; Phase IIIB/IV based on TNM criteria (8th); At least one measurable tumor based on RECIST 1.1; Without the known active mutation of EGFR/ALK/ROS1/RET; Male or female, age≥18 or ≤70 years old; ECOG PS: 0 or 1; Estimated time of survival: ≥ 3 months; Suitable hematologic function: ANC≥2×109/L, PLC≥100×109/L and Hb≥9 g/dL; Suitable liver function: Total bilirubin≤ normal ULN, AST and ALT≤2.5×normal ULN, ALP≤ 5×normal ULN; Suitable renal function: Cr≤normal ULN,or Ccr≥60 ml/min; EKG normal; Without healing wound; No history of anti-cancer therapy, or adjuvant/neo-adjuvant chemotherapy for non-metastatic tumor finished for more than 6 months before enrollment; For the female subject with productive ability, urine pregnancy test must be done and is negative within 7 days before enrollment; No history of serious allergic to biologic agents, especially E.Coli products; The authorized ICF must be signed. Exclusion Criteria: Woman in pregnancy and breast-feeding, or having productive ability without contraception; Having the serious acute infection uncontrolled or purulent/chronic infection with unhealed wound; Having the serious heart disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, valvular disease, and refractory hypertension; Having uncontrolled nervous or mental disease with low compliance and reluctance to description of response; uncontrolled primary brain tumor or other metastatic brain cancer with obvious intracranial hypertension or mental symptoms; Having the tendency of bleeding, such as FIB≤2G/L; Being receiving adjuvant chemotherapy; On other conditions investigator considers, the subject is not fitful to participate the trial.
References
Publications (0)
Data not yet available