Nintedanib in Molecularly Selected Patients With Advanced Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT02299141|
Recruitment Status : Active, not recruiting
First Posted : November 24, 2014
Last Update Posted : January 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung Non-Small Cell Lung Cancer Nonsmall Cell Lung Cancer||Drug: Nintedanib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Nintedanib in Molecularly Selected Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)|
|Actual Study Start Date :||May 7, 2015|
|Actual Primary Completion Date :||January 9, 2020|
|Estimated Study Completion Date :||August 31, 2020|
-Nintedanib will be administered orally at a dose of 200 mg twice daily during each 28 day cycle
- Response rate (RR) [ Time Frame: After 2 cycles of therapy (approximately Day 56) ]
- RR = Partial response plus complete response using RECIST 1.1
- Complete response (CR) = disappearance of all target lesions, non-target lesions, and normalization of tumor marker level
- Partial response (PR) = at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline of sum diameters
- Progression-free survival (PFS) [ Time Frame: At the time of progression (estimated to be 8 months) ]
- PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
- Progressive disease (PD) = at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, appearance of one or more non-target lesion(s) and/or unequivocal progression of existing non-target lesions
- Response rate of specific genetic mutation statuses [ Time Frame: At the time of progression (estimated to be 8 months) ]The association between response and specific mutation status will be assessed by permutation analysis. Taking the relationship between FGFR1 expression and RR as an example, for instance, we first compute the observed test statistics, e.g., the sample mean difference between responders versus non-responders. Then to simulate the null distribution of the test statistics, or the distribution of the observed mean differences if there were truly no difference, we repeat the following 10,000 times: we randomly shuffle the response status, and then calculate the sample difference between the newly designated groups. The permutation p-value equals the proportion of simulations from the null distribution that exceed the observed test statistics.
- Unique genetic variations associated with extreme responses (both non-responders and responders) [ Time Frame: At the time of progression (estimated to be 8 months) ]Unbiased exome and transcriptome sequencing performed on tumor samples at time of diagnosis in responders and non-responders will help us identify unique variations that confer susceptibility to nintedanib.
- Genetic mechanisms of secondary resistance [ Time Frame: At the time of progression (estimated to be 8 months) ]Genomic analysis at time of progression after treatment with nintedanib (after response (complete response/partial response/stable disease) lasting for 6 months or longer) will provide some unique insights into mechanisms underlying acquired resistance.
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): NCT02299141
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Ramaswamy Govindan, M.D.||Washington University School of Medicine|