Lung-MAP: A Master Screening Protocol for Previously-Treated Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT03851445|
Recruitment Status : Recruiting
First Posted : February 22, 2019
Last Update Posted : February 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Previously Treated Non-Small Cell Lung Cancer||Drug: Screening Platform||Phase 2 Phase 3|
Primary Objective of the Master Protocol (LUNGMAP)
The primary objective of this screening study is to test patient specimens to determine eligibility for participation in the biomarker-driven and non-matched sub-studies included within the Lung-MAP umbrella protocol.
Screening Success Rate Objective
To evaluate the screen success rate defined as the percentage of screened patients that register for a therapeutic sub-study. Screen success rates will be evaluated for the total screened population and by the subset of patients screened following progression on previous therapy or pre-screened on current therapy.
Translational Medicine Objectives
- To evaluate circulating tumor DNA (ctDNA) and compare to the FMI Foundation tissue molecular profiling results in patients who submit a new biopsy for screening.
- To establish a tissue/blood repository.
Ancillary Study S1400GEN Objectives
The Lung-MAP Screening Study includes an ancillary study evaluating patient and physician attitudes regarding the return of somatic mutation findings suggestive of a germline mutation. Participation in this study is optional.
To evaluate patient attitudes and preferences about return of somatic mutation findings suggestive of a germline mutation in the Lung-MAP Screening Study.
- To evaluate Lung-MAP study physician attitudes and preferences about return of somatic mutation findings suggestive of a germline mutation in the Lung-MAP Screening Study.
- To evaluate Lung-MAP patients' and study physicians' knowledge of cancer genomics.
- To evaluate Lung-MAP patients' and study physicians' knowledge of the design of the Lung-MAP Screening Study.
- To explore whether physician and patient knowledge of cancer genomics and attitudes and preferences about return of genomic profiling findings are correlated.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5000 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||The Lung-MAP study is an umbrella protocol which contains a screening component and a clinical trial component. Patients are allowed to participate in the screening component either at progression on prior therapy or to be pre-screened while receiving therapy for stage IV or recurrent NSCLC. The clinical trial component consists of biomarker-driven studies evaluating drug-biomarker combination for patients determined to have a matching biomarker and non-match studies evaluating therapies in patients without any of the study biomarkers.|
|Masking:||None (Open Label)|
|Official Title:||LUNGMAP: A Master Protocol To Evaluate Biomarker-Driven Therapies And Immunotherapies In Previously-Treated Non-Small Cell Lung Cancer (Lung-Map Screening Study)|
|Actual Study Start Date :||January 28, 2019|
|Estimated Primary Completion Date :||April 1, 2022|
|Estimated Study Completion Date :||April 1, 2022|
This is a screening study and does not have an intervention. LUNGMAP is an overarching umbrella study to which patients are screened and then assigned to a treatment sub-study. The treatment sub-studies are standalone trials and have their own NCT numbers. The Lung-MAP Study is considered a single study under one IND, consisting of the Screening Protocol and multiple sub-studies. Each sub-study protocol operates independently and has its own version date.
Drug: Screening Platform
The screening study tests patient specimens to determine eligibility for participation in the biomarker-driven and non-matched sub-studies included within the Lung-MAP umbrella protocol.
- Screening Success (Tissue Submission) [ Time Frame: Up to 3 years ]The tissue submission will be measured by the proportion of patients who register to this screening study for whom a tissue sample is submitted.
- Screening Success (Adequate Tissue) [ Time Frame: Up to 3 years ]Adequate tissue will be measured by the proportion of patients who submitted a specimen for whom genomic results were successfully obtained, if multiple platforms are being used (e.g. both FMI and IHC), these rates will be summarized by the individual assays and combined. These rates are summarized for the entire screened population and by screening type (screened at progression versus pre-screened prior to progression). The rates are evaluated for both the initial submission success rates and the overall success rate accounting for new tissue submissions following an unsuccessful result.
- Screening Success (Prescreening-to-sub-study Assignment) [ Time Frame: Up to 3 years ]Pre-screening-to-sub-study assignment will be measured among pre-screened patients and the proportion of patients assigned to a sub-study (which is triggered by the submission of the notice of progression form, see Section 14.0). Note: Patients screened at progression are notified of their sub-study assignment within 1 day of the biomarker results being reported to SWOG.
- Screening Success (Notice of Intention Not to Register Submission) [ Time Frame: Up to 3 years ]Screening success will be measured by the reasons for non-participation collection on the LungMAP Notice of Intention not to Register Form. The proportions of patients with this form submitted are summarized overall and by screening type. The reasons for submission are summarized overall and by screening type.
- Screening Success (Match to Biomarker-Driven Sub-Study) [ Time Frame: Up to 3 years ]Match to Biomarker-Driven Sub-Study will be measured by successful biomarker screening, the proportion assigned to a biomarker-driven substudy.
- Screening Success (Assignment Success) [ Time Frame: Up to 3 years ]Assignment Success will be measured by the proportion of patients assigned to a sub-study who are registered to a sub-study, these rates are summarized overall and among biomarker-driven and non-match sub-study assignments, separately. In addition, these rates are summarized by screening type.
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): NCT03851445
|Contact: Mariah Normanemail@example.com|
|Contact: Sara Ricefirstname.lastname@example.org|
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|Study Chair:||Vassiliki Papadimitrakopoulou||Southwest Oncology Group|