A Study of PC Sequential Pemetrexed Single Drug Maintenance Treatment for NSCLC and Related Predictive Biomarkers
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ClinicalTrials.gov Identifier: NCT01860508 |
Recruitment Status : Unknown
Verified July 2013 by Jialei Wang, Fudan University.
Recruitment status was: Recruiting
First Posted : May 22, 2013
Last Update Posted : July 8, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-small Cell Lung Cancer | Drug: pemetrexed /carboplatin | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 94 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Advanced Metastatic Non-small Cell Lung Cancer Patients Aged or PS Score 2 Points for First Line Application Pemetrexed/Carboplatin Chemotherapy Regimens Sequential Pemetrexed Single Drug Maintenance Treatment of Clinical Research and Related Predictive Biomarkers of Exploratory Research |
Study Start Date : | February 2013 |
Estimated Primary Completion Date : | February 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: pemetrexed |
Drug: pemetrexed /carboplatin |
- PFS [ Time Frame: from the first cycle of treatment (day one) to two month after the last cycle ]

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Ages Eligible for Study: | 70 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
.≥65 years or PS 2
- Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer
- Patients received no chemical therapy or only received targeted therapy,and there is evidence show the patent is PD
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Presence of at least one index lesion measurable by CT scan or MRI
- leucocyte ≥ 3.5×109/L
- neutrophil ≥ 1.5×109/L
- platelet ≥ 80×109/L
- Hemoglobin ≥ 9g/L
- ALT and AST ≤ 2.5×ULN ,Tbil≤ 1.5×ULN
- BUN≤ 1.5×ULN
- Signed written informed consent
Exclusion Criteria:
- squamous carcinoma or small cell lung cancer
- Patients were allergic to pemetrexed
- Patients received chemotherapy before
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Uncontrolled acute infection
.Uncontrolled pleural effusion
- Severe symptomatic heart disease
- Severe infection or metabolic disfunction
- Patients with other malignant tumor
- Uncontrolled brain metastases
- Patients have accepted other clinical trials
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Female patients during their pregnant and lactation period, or patients without contraception
- Mental disorientation of disorder
- Glucocorticoids taboo

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): NCT01860508
Contact: Jia lei Wang, Master | 02164175590 ext 8907 | luwangjialei@hotmail.com |
China, Shanghai | |
Cancer hospital Fudan University | Recruiting |
Shanghai, Shanghai, China, 200032 | |
Contact: Jia lei Wang, Master 02164175590 ext 8907 luwangjialei@hotmail.com |
Responsible Party: | Jialei Wang, Attending doctor of medical oncology, Fudan University |
ClinicalTrials.gov Identifier: | NCT01860508 |
Other Study ID Numbers: |
2013-PEM-WJL |
First Posted: | May 22, 2013 Key Record Dates |
Last Update Posted: | July 8, 2013 |
Last Verified: | July 2013 |
Progression free Survival |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic |
Bronchial Neoplasms Carboplatin Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |