Trial Outcomes & Findings for Genetic Sequencing-Informed Targeted Therapy in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer (NCT NCT02132884)
NCT ID: NCT02132884
Last Updated: 2019-09-04
Results Overview
A chi-square test (one-sided; alpha = .1) will be used to assess the efficacy of treating patients with targeted agents based in the Cancer-Code-50 in the second line setting. For each patient "success" will be defined as being progression free for at least 3 months following initiation of second line therapy. Progression free survival times will be characterized separately by arm using the method of Kaplan and Meier.
TERMINATED
NA
1 participants
Time from start of second line treatment to time of progression or death, whichever occurs first, assessed at 3 months
2019-09-04
Participant Flow
Participant milestones
| Measure |
Arm A (Standard of Care Treatment)
Patients receive standard of care treatment based on the discretion of the treating physician.
therapeutic procedure: Receive standard of care treatment
laboratory biomarker analysis: Correlative studies
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Arm B (Genetic Sequencing and Targeted Therapy)
Patients undergo collection of tissue and blood samples for analysis via sequencing. Upon disease progression following front-line treatment, patients receive specific targeted therapy based on the mutational status obtained during sequencing.
cytology specimen collection procedure: Undergo collection of tissue and blood samples
targeted therapy: Receive specific targeted therapy
laboratory biomarker analysis: Correlative studies
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Overall Study
STARTED
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Overall Study
COMPLETED
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Genetic Sequencing-Informed Targeted Therapy in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Time from start of second line treatment to time of progression or death, whichever occurs first, assessed at 3 monthsPopulation: There was only one patient enrolled and the study was closed before the patient started treatment.
A chi-square test (one-sided; alpha = .1) will be used to assess the efficacy of treating patients with targeted agents based in the Cancer-Code-50 in the second line setting. For each patient "success" will be defined as being progression free for at least 3 months following initiation of second line therapy. Progression free survival times will be characterized separately by arm using the method of Kaplan and Meier.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: There was only one patient enrolled and the study was closed before the patient started treatment.
The response rate (with 95% two-sided confidence intervals) will be computed separately by arm. One-sided chi-square or Fisher's exact tests (alpha = .1) will be used to evaluate differences in response rates between arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: There was only one patient enrolled and the study was closed before the patient started treatment.
To assess the effect of sequencing on clinical practice and decision making the proportion of Arm B patients whose second line therapy is changed as a result of physician access to CancerCode-50 results will be computed. This comparison will be based on information provided by the treating physician before being exposed to the sequencing results, and information obtained from a from post-treatment chart review.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsThe concordance of variants identified when sequencing will be performed on samples from the same patient collected at baseline and follow-up time points will also be measured.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsThe incidence of non-protocol testing of those patients in Arm A who undergo molecular testing (by any method) at the discretion of the treating physician will be estimated.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsThe response rate of those patients in Arm A who undergo molecular testing (by any method) at the discretion of the treating physician will be estimated.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Time from start of second line treatment to time of progression or death, whichever occurs first, assessed up to 2 yearThe progression free survival of those patients in Arm A who undergo molecular testing (by any method) at the discretion of the treating physician will be estimated.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (Standard of Care Treatment)
Arm B (Genetic Sequencing and Targeted Therapy)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place