Pemetrexed/Cisplatin With or Without Bevacizumab in Brain Metastases From Non Squamous Non-small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT01951482 |
Recruitment Status : Unknown
Verified October 2017 by Li-kun Chen, Sun Yat-sen University.
Recruitment status was: Recruiting
First Posted : September 26, 2013
Last Update Posted : October 26, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non Squamous Non-small Cell Lung Cancer Brain Metastases Bevacizumab | Drug: Pemetrexed/cisplatin Drug: Bevacizumab and Pemetrexed/cisplatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 108 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Multicenter Phase II Study of Pemetrexed/Cisplatin With or Without Bevacizumab in Patients With Brain Metastases From Non Squamous Non-small Cell Lung Cancer Harboring EGFR Wild Type |
Study Start Date : | June 2013 |
Estimated Primary Completion Date : | December 2019 |
Estimated Study Completion Date : | June 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Bevacizumab and Pemetrexed/cisplatin
Bevacizumab 7.5mg/kg d1+Pemetrexed/cisplatin q21d
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Drug: Bevacizumab and Pemetrexed/cisplatin
receive Bevacizumab 7.5mg/kg and Pemetrexed/cisplatin every 21 days |
Active Comparator: Pemetrexed/cisplatin
Pemetrexed/cisplatin q21d
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Drug: Pemetrexed/cisplatin
receive Pemetrexed/cisplatin every 21 days |
- Compare iPFS(intracranial progression free survival) in two arms [ Time Frame: 3 Years ]
- Response rate(CR&PR) [ Time Frame: 3 years ]
- PFS: progress free survival [ Time Frame: 3 years ]
- OS: overall survival [ Time Frame: 3 years ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient who was confirmed stage IV non squamous NSCLC with EGFR wild type and brain metastases by pathologic histology or cytology
- Patients who had never received therapy (including chemotherapy,WBRT,and Bevacizumab) after diagnosed brain metastases
- Appraisable disease, the presence of at least three lesions if longest diameter <10 mm by brain MRI
- Adult patients (≥ 18 years and ≤75 years). ECOG Performance Status 0 or 1 Life expectancy of at least 12 weeks.,Haemoglobin ³ 10.0 g/dl, Absolute neutrophil count (ANC) ³1.5 x 109/L, platelets ³ 100 x 109/L. Total bilirubin £ 1.5 x upper limit of normal (ULN). ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases. Creatinine clearance ³ 60ml/min (calculated according to Cockcroft-gault formula).
- Patients should be contraceptive during the period of the trial
Exclusion Criteria:
- Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component.
- History of haemoptysis
- Evidence of tumour invading major blood vessels on imaging.
- Patient was received irradiation of brain. Patient with meningeal metastases were confirmed by MRI or cytology test of cerebrospinal fluid.
- Previous radiotherapy.
- Serious uncontrolled coagulation disorder or thrombi-embolic complications within 6 months prior to study start or history of serious bleeding complications.
- Major surgical procedures within 4 weeks prior to study entry.
- Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion.
- Non-healing wound, active peptic ulcer or bone fracture.
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrollment

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): NCT01951482
Contact: li-kun hen, Doctor | 13798019964 |
China, Guangdong | |
Sun Yat-sen University of Cancer Center | Recruiting |
Guangzhou, Guangdong, China, 510060 | |
Contact: li-kun Chen, doctor 13798019964 chenlk@sysucc.org.cn |
Study Director: | li-kun Chen, Doctor | Sun Yat-sen University |
Responsible Party: | Li-kun Chen, medical doctor, Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT01951482 |
Other Study ID Numbers: |
NSCLC brain metastasis 02 |
First Posted: | September 26, 2013 Key Record Dates |
Last Update Posted: | October 26, 2017 |
Last Verified: | October 2017 |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Neoplasm Metastasis Brain Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Neoplastic Processes Pathologic Processes Central Nervous System Neoplasms |
Nervous System Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Bevacizumab Cisplatin Pemetrexed Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Enzyme Inhibitors |