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A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)

Primary Objective of the Master Protocol (S1400) The overarching goal for this protocol is to establish a National Clinical Trials Network (NCTN) mechanism for genomically screening large but homogeneous cancer populations and subsequently assigning and accruing simultaneously to a multi-sub-study Master Protocol . Biomarker-driven sub-studies in this protocol will evaluate a targeted therapy (TT) or targeted therapy combination (TTC) based on designated therapeutic biomarker-drug combinations, with the ultimate goal being approval of new targeted therapies in this setting. In addition, the protocol includes at least one non-match sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will evaluate a non-match therapy (NMT), also with the goal of approval. For all sub-studies the investigational therapy arm will be referred to as the investigational therapy arm. We hypothesize that this Master Protocol mechanism will yield definable and measurable efficiencies in terms of improving genomic screening of cancer patients for clinical trial entry, and improved time lines for drug-biomarker testing allowing for inclusion of the maximum numbers of otherwise eligible patients in comparison with currently employed single screen-single trial approaches. This Protocol employs a hybrid master protocol in which the design for a given sub-study is chosen from a limited number of clinical trials designs based on the expected biomarker prevalence and background data. The design options for the sub-studies include a Phase II/III design and a Single Arm Phase II followed by a Randomized Phase III (under specified conditions). The objectives for each design are included in this section (Section 1.0) and the statistical considerations for each design are included in S1400 Section 11.0.

Primary Objective of the Master Protocol (S1400) The overarching goal for this protocol is to establish a National Clinical Trials Network (NCTN) mechanism for genomically screening large but homogeneous cancer populations and subsequently assigning and accruing simultaneously to a multi-sub-study Master Protocol . Biomarker-driven sub-studies in this protocol will evaluate a targeted therapy (TT) or targeted therapy combination (TTC) based on designated therapeutic biomarker-drug combinations, with the ultimate goal being approval of new targeted therapies in this setting. In addition, the protocol includes at least one non-match sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will evaluate a non-match therapy (NMT), also with the goal of approval. For all sub-studies the investigational therapy arm will be referred to as the investigational therapy arm. We hypothesize that this Master Protocol mechanism will yield definable and measurable efficiencies in terms of improving genomic screening of cancer patients for clinical trial entry, and improved time lines for drug-biomarker testing allowing for inclusion of the maximum numbers of otherwise eligible patients in comparison with currently employed single screen-single trial approaches. This Protocol employs a hybrid master protocol in which the design for a given sub-study is chosen from a limited number of clinical trials designs based on the expected biomarker prevalence and background data. The design options for the sub-studies include a Phase II/III design and a Single Arm Phase II followed by a Randomized Phase III (under specified conditions). The objectives for each design are included in this section (Section 1.0) and the statistical considerations for each design are included in S1400 Section 11.0.