Rh-Endostatin (Endostar®) Continuous Intravenous Infusion
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03706703 |
Recruitment Status : Unknown
Verified October 2018 by Affiliated Cancer Hospital & Institute of Guangzhou Medical University.
Recruitment status was: Recruiting
First Posted : October 16, 2018
Last Update Posted : October 17, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lung Cancer | Drug: Endostar Drug: Docetaxel Drug: Carboplatin Drug: Pemetrexed | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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) |
Actual Study Start Date : | October 1, 2018 |
Estimated Primary Completion Date : | April 1, 2020 |
Estimated Study Completion Date : | September 1, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Endostar continuous intravenous infusion
Endostar continuous intravenous infusion in combination with docetaxel/carboplatin or pemetrexed/carboplatin
|
Drug: Endostar
continuous intravenous infusion Endostar,7.5mg/m2, continuous intravenous infusion for 14 days each cycle, 21 days as one cycle, 4 cycles in total. Drug: Docetaxel docetaxel is 75 mg/m2 intravenously over 1 hour on Day 1 of each 21-day cycle Drug: Carboplatin carboplatin is administered on Day 1 of each 21-day,followed by docetaxol or pemetrexed Drug: Pemetrexed pemetrexed is 500 mg/m2 intravenously on Days 1 of each 21-day cycle |
- ORR [ Time Frame: 8 weeks ]objective response rate based on Recist 1.1 edition
- PFS [ Time Frame: 8 weeks ]progress free survival

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706703
China, Guangdong | |
Affiliated Cancer Hospital & Institute of Guangzhou Medical University | Recruiting |
Guangzhou, Guangdong, China, 510000 | |
Contact: Chuan Jin, post-graduate 020-66673666 18302078099@163.com |
Responsible Party: | Affiliated Cancer Hospital & Institute of Guangzhou Medical University |
ClinicalTrials.gov Identifier: | NCT03706703 |
Other Study ID Numbers: |
ENDOSTAR |
First Posted: | October 16, 2018 Key Record Dates |
Last Update Posted: | October 17, 2018 |
Last Verified: | October 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carboplatin Docetaxel Pemetrexed Endostar protein Antineoplastic Agents |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |