Clinical trial · Interventional
Endostar First-line Treatment of Advanced NSCLC
The Efficacy and Safety of Continuous Administration of Endostar Combined With Chemotherapy for Patients With Advanced no Small Cell Lung Cancer: An Open-label, no Randomized Controlled Multicenter Phase II Study
NCT03123445CI-TRIAL-00027124unknownPhase 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)
Explore the efficacy and safety of the treatment of Endostar continuous intravenous injection pump combined GP(gemcitabine+cisplatin) scheme for first-line advanced non small cell lung cancer and maintenance treatment.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Endostar | Drug | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Endostar + Gemcitabine and Cisplatin
- description
- Patients in this group will be given endostar combined with gemcitabine and cisplatine.
- interventionNames
- Drug: Endostar
- Drug: Gemcitabine
- Drug: Cisplatin
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine and Cisplatin
- description
- Patients in this group will be given gemcitabine and cisplatine.
- interventionNames
- Drug: Gemcitabine
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Progression-free Survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Cytological and histological confirmation(Do not accept single sputum cytology in the diagnosis of patients) in patients diagnosed of lung squamous carcinoma; According to a new IASLC (International Association for the Study of Lung Cance) 2009 lung cancer TNM (tumor node metastasis) stages judged stage IIIB or IV non-small cell lung cancer. * Must have at least one evaluated lesion,according to the RECIST version 1.1 standard (the longest diameter on spiral CT at least 10 mm,the longest diameter on plain CT at least 20 mm); * Male or female, age between 18 and 75 years old ; * ECOG(Eastern Cooperative Oncology Group) PS (performance status ) 0\~1; * Expected survival period ≥ 3 months or more * Enough blood function: absolute neutrophil count (ANC)≥2 x 109 / L and the platelet count≥ 100 x 109 / L and hemoglobin ≥9 g/dL; * Enough liver function: total bilirubin acuities≤the upper limit of normal (ULN); aspartate aminotransferase(AST) and Alanine aminotransferase(ALT) acuities ≤2.5 times of the upper limit of normal (ULN); Alkaline phosphatase ≤5 times of the upper limit of normal(ULN); * Enough renal function:serum creatinine ≤the limit of normal(ULN) or calculated creatinine clearance≥60 mL/min. * The electrocardiogram (ecg) basically normal,the body had no to heal wounds * No previous anti-tumor drug therapy, or only received for non metastatic tumor of adjuvant or neoadjuvant chemotherapy, but has ended more than six months before the study start. * Patients had surgery before,but have more than 4 weeks before the study start, and the patient has recovered; * Women with completed uterus before intact in the group within 28 days must have a negative pregnancy test results (unless amenorrhea for 24 months). If the pregnancy test from the first time for more than 7 days,the patients need for urine pregnancy test(within 7 days before the first delivery). * Prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions; * Sign the informed consent. Exclusion Criteria: * Pregnancy, nursing mothers, or female patients with fertility but no contraception. * Existing serious acute infection, and can not be controlled; Or with fester sex and chronic infection,or wound in delay; * Original serious heart disease, including: congestive heart failure, uncontrolled high risk arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension; * With uncontrolled nerve, mental illness or mental disorders, compliance is poor, can't cooperate and response to treatment; Uncontrolled primary brain tumors or central nervous system(CNS) metastases illness, with obvious symptoms in cranial hypertension or nerve spirit; * With a bleeding tendency * Researchers believe that patients should not participate in this test.
References
Publications (4)
- BACKGROUNDWang J, Gu LJ, Fu CX, Cao Z, Chen QY. Endostar combined with chemotherapy compared with chemotherapy alone in the treatment of nonsmall lung carcinoma: A meta-analysis based on Chinese patients. Indian J Cancer. 2014 Mar;51 Suppl 3:e106-9. doi: 10.4103/0019-509X.154099. PMID 25818734
- BACKGROUNDHu W, Fang J, Nie J, Dai L, Zhang J, Chen X, Ma X, Tian G, Wu D, Han S, Han J, Wang Y, Long J. Efficacy and safety of extended use of platinum-based doublet chemotherapy plus endostatin in patients with advanced nonsmall cell lung cancer. Medicine (Baltimore). 2016 Jul;95(28):e4183. doi: 10.1097/MD.0000000000004183. PMID 27428214
- BACKGROUNDRong B, Yang S, Li W, Zhang W, Ming Z. Systematic review and meta-analysis of Endostar (rh-endostatin) combined with chemotherapy versus chemotherapy alone for treating advanced non-small cell lung cancer. World J Surg Oncol. 2012 Aug 24;10:170. doi: 10.1186/1477-7819-10-170. PMID 22917490
- RESULTZhang FL, Gao EY, Shu RB, Wang H, Zhang Y, Sun P, Li M, Tang W, Jiang BQ, Chen SQ, Cui FB. Human Recombinant Endostatin Combined with Cisplatin Based Doublets in Treating Patients with Advanced NSCLC and Evaluation by CT Perfusion Imaging. Asian Pac J Cancer Prev. 2015;16(15):6765-8. doi: 10.7314/apjcp.2015.16.15.6765. PMID 26434908