Sequential Use of Low-dose Sunitinib With Chemotherapy in Advanced NSCLC After Failure of Conventional Regimen
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ClinicalTrials.gov Identifier: NCT01850147 |
Recruitment Status : Unknown
Verified May 2013 by LI Junling, Chinese Academy of Medical Sciences.
Recruitment status was: Recruiting
First Posted : May 9, 2013
Last Update Posted : May 9, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cancer Lung Cancer | Drug: Sunitinib, chemotherapy | 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: | Study of Efficacy and Safety of Sequential Low-dose Sunitinib With Chemotherapy in Advanced Non-small Cell Lung Cancer After Failure of Conventional Regimen |
Study Start Date : | March 2013 |
Estimated Primary Completion Date : | October 2014 |
Estimated Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Sunitinib |
Drug: Sunitinib, chemotherapy
sunitinib, 12.5mg/day, for 7 days before each cycle of chemotherapy; chemotherapy, single agent including docetaxel, albumin-bound paclitaxel, vinorelbine, gemcitabine, pemetrexed, or paclitaxel, as determined by the investigator |
- progression-free survival [ Time Frame: up to 2 years ]The primary objective of this study is to evaluate the median progression-free survival of this sequential regimen.
- overall survival [ Time Frame: up to 2 years ]To evaluate the median over-all survival of this regimen
- disease control rate [ Time Frame: up to 6 months ]To evaluate the disease-control rate of this regimen.
- Safety [ Time Frame: up to 2 years ]To evaluate the safety of this regimen including the rate and grade of adverse effects.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologic or cytologic diagnosis of stage IIIB/IV NSCLC
- ECOG PS: 0,1
- Unidimensional or bi-dimensional measurable disease
- Receive prior treatment including first-line platinum-based chemotherapy, standard second-line chemotherapy and 1 EGF/EGFR inhibitor
- Evidence of disease progression
- Life expectancy >12 weeks
- Neutrophils > 1.5 109/l, Platelets > 100 109/l, Hemoglobin > 9g/dl, Total bilirubin < 1.5 UNL, AST (SGOT) and ALT (SGPT) < 2.5 UNL, Alkaline phosphatases < 5 UNL, Creatinine < 1 UNL
Exclusion Criteria:
- Pre-existing hemoptysis of a severity > grade 3 by NCI CTCAE criteria within 4 weeks prior to study entry
- Uncontrolled hypertension
- CHF, angina or arrhythmias
- LVEF < 1 UNL
- Existing a second malignancy within 5 years
- Infected with HIV

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): NCT01850147
Contact: Junling Li | 86-13801178891 | drlijunling@yahoo.cn |
China | |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting |
Beijing, China, 100021 |
Responsible Party: | LI Junling, Professor and Chief physician, Chinese Academy of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT01850147 |
Other Study ID Numbers: |
SU-2013-041 |
First Posted: | May 9, 2013 Key Record Dates |
Last Update Posted: | May 9, 2013 |
Last Verified: | May 2013 |
sunitinib chemotherapy non-small cell lung cancer NSCLC |
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Sunitinib Antineoplastic Agents |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |