A Study of Continuous Endostar Intravenous Infusion Combined With Pemetrexed and Carboplatin in Advanced Non Small Cell Lung Cancer Patients

A Phase I Study of Continuous Endostar Intravenous Infusion Combined With Pemetrexed and Carboplatin in Advanced NSCLC Patients

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01531790

Enrollment

Registered

2012-02-13

Start date

2011-09-30

Completion date

2012-12-31

Last updated

2013-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Keywords

Endostar, Carboplatin, Pemetrexed, NSCLC, Phase I

Brief summary

This study is to evaluate the safety, tolerability, clinical efficacy and pharmacokinetics of continuous Endostar intravenous infusion combined with pemetrexed and carboplatin in advanced non small cell lung cancer (NSCLC) patients.

Interventions

DRUGCarboplatin

d1, AUC 5, i.v.

DRUGPemetrexed

d1, 500 mg/m2, i.v.

DRUGEndostar

d2-d21, continuous Endostar intravenous infusion, 7.5 mg/m2/d, 15 mg/m2/d or 30 mg/m2/d, etc.

DRUGCentrum

1 tablet/day

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Histological or cytological diagnosis of inoperable stage IIIB/IV non-squamous NSCLC * At least one measurable lesion (RECIST criteria) * Life expectancy \> 3 months * ECOG performance status 0-2 * Adequate hematologic function: WBC ≥ 3.0×109 /L，ANC ≥ 1.5×109 /L，Hb ≥ 90 g/L，PLT ≥ 100×109 /L * Adequate renal, hepatic and coagulation function * Written informed consent

Exclusion criteria

* With uncontrollable malignant pleural effusion or ascites * Thoracic or abdominal surgery within 28 days prior to study entry * History of cerebral stroke or TIA within 6 months prior to study entry * With uncontrollable hypertension, hypertensive emergency or hypertensive encephalopathy * Arrhythmia in need of antiarrhythmic treatment, history of angina pectoris, myocardial infarction, myocardial ischemia or congestive heart failure (\> NYHA class II) * With serious infection (\> NCI CTC grade 2) * Gastrointestinal perforation, fistula formation, and/or intra-abdominal abscess within 6 months prior to study entry * Symptomatic brain metastases * Patient who has epilepsy * History of HIV infection or chronic hepatitis B or C * Allergic to any of the study drugs * Pregnant or lactating women

Design outcomes

Primary

Measure	Time frame
Dose Limiting Toxicity	up to 21 days

Secondary

Measure	Time frame
Objective Response Rate	up to 6 cycles
Disease Control Rate	up to 6 cycles
Progression-free Survival	up to 2 years
Overall Survival	up to 2 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026