A Phase 2 Study of CRLX101(NLG207) in Patients With Advanced Non-Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT01380769 |
Recruitment Status :
Completed
First Posted : June 27, 2011
Results First Posted : May 24, 2017
Last Update Posted : May 28, 2020
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Sponsor:
NewLink Genetics Corporation
Information provided by (Responsible Party):
Lumos Pharma ( NewLink Genetics Corporation )
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Tracking Information | ||||
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First Submitted Date ICMJE | June 22, 2011 | |||
First Posted Date ICMJE | June 27, 2011 | |||
Results First Submitted Date ICMJE | October 26, 2015 | |||
Results First Posted Date ICMJE | May 24, 2017 | |||
Last Update Posted Date | May 28, 2020 | |||
Study Start Date ICMJE | June 2011 | |||
Actual Primary Completion Date | February 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
To Compare Overall Survival of Patients Treated With CRLX101 + BSC to Those Patients Treated With BSC Only [ Time Frame: Up to 18 months ] Comparison of survival among patients treated with CRLX101 + best supportive care vs patients treated wiht best supportive care only.
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Original Primary Outcome Measures ICMJE |
To compare overall survival of patients treated with CRLX101 to those patients treated with best supportive care. [ Time Frame: Up to 18 months ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Assess Objective Response Rate (ORR) of CRLX101+ BSC Compared to BSC Only [ Time Frame: 12 months ] Comparison of objective response rate in subjects treated with CRLX101+BSC versus subjects treated with BSC alone.
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Phase 2 Study of CRLX101(NLG207) in Patients With Advanced Non-Small Cell Lung Cancer | |||
Official Title ICMJE | A Randomized, Phase 2, Study to Assess the Safety and Activity of CRLX101, a Nanoparticle Formulation of Camptothecin, in Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed One or Two Previous Regimens of Chemotherapy | |||
Brief Summary | The purpose of this study is to compare median overall survival of patients with advanced non-small cell lung cancer (NSCLC) treated with CRLX101 to patients treated with best supportive care (BSC). | |||
Detailed Description | Lung cancer remains the leading cause of cancer-related mortality in men and women worldwide. Non-small cell lung cancer (NSCLC) accounts for approximately 80% of all lung cancer. The development of targeted therapies has changed the approach to treating NSCLC significantly over the past decade with targeted therapies generally possessing safety advantages over traditional cytotoxic regimens. However, combination paradigms and resistance patterns complicate the use of these agents. CRLX101 is a nanoparticle comprised of camptothecin (CPT) conjugated to a cyclodextrin-based polymer. CRLX101 is designed to increase the exposure of tumor cells to CPT while minimizing side effects. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Non-Small Cell Lung Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
157 | |||
Original Estimated Enrollment ICMJE |
148 | |||
Actual Study Completion Date ICMJE | October 2014 | |||
Actual Primary Completion Date | February 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Russian Federation, Ukraine | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01380769 | |||
Other Study ID Numbers ICMJE | CRLX-002 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Lumos Pharma ( NewLink Genetics Corporation ) | |||
Study Sponsor ICMJE | NewLink Genetics Corporation | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Lumos Pharma | |||
Verification Date | May 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |