Paclitaxel-Carboplatin Alone or With M2ES for Non-Small-Cell Lung Cancer

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy of Paclitaxel-Carboplatin Alone or With Pegylated Endostatin for Advanced Non-small Cell Lung Cancer

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01527864

Enrollment

300

Registered

2012-02-07

Start date

2011-05-31

Completion date

2013-04-30

Last updated

2012-02-07

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

NSCLC

Brief summary

A phase II, multicenter, randomized, double-blind, placebo-controlled study was carried out. Patients were randomly assigned to the treatment (PC + pegylated endostatin) or the control group (PC+ placebo). The efficacy was evaluated every six weeks.Follow-up continued until disease progression or death.

Detailed description

A randomized phase 2 study, involving patients with advanced non-small-cell lung cancer who had not previously received chemotherapy, compared paclitaxel and carboplatin Plus placebo with paclitaxel and carboplatin plus PEGylated endostatin, with PEGylated endostatin at a dose of 10 mg/m2 intravenously every weeks.

Interventions

DRUGpegylated endostatin and Paclitaxel-Carboplatin

Dosage：10mg/m2

DRUGPlacebo and Paclitaxel-Carboplatin

Dosage：10mg/m2

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Histologically or cytologically confirmed, newly diagnosed stage IIIB or stage IV cancer or recurrent non-small-cell lung cancer for which they had not received chemotherapy, targeted therapy. 2. Prior radiation therapy was allowed provided that the only sites disease were not located in lung. 3. Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST). 4. ≥18 years of age. 5. ECOG performance status of 0 or 1. 6. Life expectancy of at least 12 weeks. 7. Adequate hematologic, hepatic, and renal function. 8. Patients are voluntary to participate and sigh the informed contents.

Exclusion criteria

1. Major surgery within the prior 4 weeks. 2. Participating any clinical trial within the prior 4 weeks. 3. Patients had clinically apparent CNS disease ( primary brain tumors, tumor related apoplexy, CNS metastases, carcinomatous meningitis.) 4. Another active malignancy, or any history of other malignancy within the past 3 years except for nonmelanoma skin cancer and carcinoma in situ of the cervix. 5. Pregnant or lactating women. 6. Radiation therapy have not been completed 4 weeks before enrollment. 7. Pulmonary embolus, deep venous thrombosis or bleeding diathesis. 8. Uncontrolled intercurrent illness as following: prior or ongoing uncontrolled hypertension;angina pectoris; congestive cardiac failure; myocardial ischemia, infarction, uncompensated coronary artery disease within the past 12 months; Uncontrolled arrhythmia; Uncontrolled diabetes mellitus; Uncontrolled infection. 9. Grade 2 hemoptysis within the past 6 months. 10. Acute or chronic renal disease. 11. Active hepatitis or HIV. 12. ECG: QTC ≥ 480 ms. 13. Patients on therapeutic doses of heparin. 14. Other conditions that are regarded for exclusion by the investigator.

Design outcomes

Primary

Measure	Time frame
Progression free survival	6 weeks

Countries

China

Contacts

Primary ContactYan Sun, MD

cancergcp@163.com8610-87788495

Outcome results

None listed

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