{"corpus_id":240541392,"paper_sha":"363bae2c9a8829ca6eec05c21c90a43cb5715577","doi":"10.1200/jco.2020.39.28_suppl.59","arxiv_id":null,"pmid":null,"pmcid":null,"mag_id":3199580546,"dblp_id":null,"acl_id":null,"title":"Improvements in access to cancer clinical trials facilitated by comprehensive genomic profiling in non-small cell lung cancer.","year":2021,"publication_date":"2021-09-21","venue":"Journal of Clinical Oncology","journal":{"name":"Journal of Clinical Oncology","pages":null,"volume":null},"journal_issn":null,"journal_title":null,"publication_types":[],"pubmed_pub_types":null,"s2_fields_of_study":["Medicine"],"reference_count":0,"citation_count":0,"influential_citation_count":0,"is_open_access":false,"arxiv_categories":null,"arxiv_license":null,"arxiv_journal_ref":null,"mesh_headings":null,"chemicals":null,"comments_corrections":null,"source_flags":1,"s2_open_access_pdf_url":null,"s2_open_access_landing_url":null,"s2_open_access_license":null,"s2_open_access_status":null,"pmc_open_access_pdf_url":null,"pmc_open_access_landing_url":null,"pmc_open_access_license":null,"pmc_open_access_status":null,"unpaywall_open_access_pdf_url":null,"unpaywall_open_access_landing_url":null,"unpaywall_open_access_license":null,"unpaywall_open_access_status":null,"abstract":"59 Background: The use of comprehensive genomic profiling (CGP) in cancer patients could lead to additional enrollment in clinical trials that study novel genetic biomarkers, potentially reducing treatment costs for payers and improving health outcomes for patients. Our objective was to estimate the number of additional clinical trials in which patients with non-small cell lung cancer (NSCLC) could potentially enroll due to the use of CGP vs. a comparator panel of 50 genes or less. Methods: Clinical trials in NSCLC that started between 2015 - 2020 were identified from the Aggregate Analysis of ClinicalTrials.gov (AACT) database. Trials with unknown status or study sites outside the United States only were excluded. We abstracted information on required genetic alterations based on the study eligibility criteria. We calculated the incremental number of trials available to patients due to results generated by CGP (FoundationOne CDx, 324 genes) vs. a commercially available comparator panel that was 50 genes or less (Oncomine Dx Target Test, 23 genes) by phase and calendar year. The additional trials were characterized by disease severity, type of therapy, and setting. Results: Enrollment eligibility was dependent on genetic variant status in 35% (250/709) of all identified NSCLC trials. There were 29 (248 vs. 219) additional clinical trials available to patients through the use of CGP, 12% of all gene-specific trials for NSCLC. We identified 45 uses of genetic markers in the 29 additional clinical trials. The most frequent genetic marker in the incremental trials was microsatellite instability, accounting for 44% of all identified markers (20/45). The incremental number of trials available to patients due to the use of CGP did not vary significantly over time but varied by phase – most of the additional clinical trials were in phase 1 or 2 (28/29, 97%). Most of the incremental trials were in metastatic disease (22/29, 76%) and were conducted in academic or advanced community settings (18/29, 62%). The most frequently studied type of intervention in these studies was targeted monotherapy (8/29, 28%), followed by immuno-monotherapy (7/29, 24%). Conclusions: Clinical trials in NSCLC initiated over the past 5 years have consistently included CGP-specific genes or markers in eligibility criteria. Patients with NSCLC have the potential to benefit from the use of CGP as compared to smaller gene panels through improved access to clinical trials.[Table: see text]","claims":[{"public_id":"cl_705980b087f4689267eb6d542a5a4694","status":"active","text":"Clinical trials in non-small cell lung cancer that started between 2015 and 2020 were identified from the Aggregate Analysis of ClinicalTrials.gov database and assessed for required genetic alterations in eligibility criteria.","confidence":0.95,"contributors":[{"id":136,"public_id":"3c2apqe3ut","public_label":"Anonymous (3c2apqe3ut)","roles":["extraction"],"url":"https://sah.borca.ai/u/3c2apqe3ut"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/claims/cl_705980b087f4689267eb6d542a5a4694"},{"public_id":"cl_9f538753131fb027b44de5719055ab53","status":"active","text":"Comprehensive genomic profiling provided 29 additional clinical trials for potential patient enrollment compared with the Oncomine Dx Target Test comparator panel.","confidence":0.97,"contributors":[{"id":136,"public_id":"3c2apqe3ut","public_label":"Anonymous (3c2apqe3ut)","roles":["extraction"],"url":"https://sah.borca.ai/u/3c2apqe3ut"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/claims/cl_9f538753131fb027b44de5719055ab53"},{"public_id":"cl_49cf93490dfe66f3d44354142336e56e","status":"active","text":"Enrollment eligibility depended on genetic variant status in 35% of the identified non-small cell lung cancer trials.","confidence":0.98,"contributors":[{"id":136,"public_id":"3c2apqe3ut","public_label":"Anonymous (3c2apqe3ut)","roles":["extraction"],"url":"https://sah.borca.ai/u/3c2apqe3ut"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/claims/cl_49cf93490dfe66f3d44354142336e56e"},{"public_id":"cl_74d2209f35a3aff1dac44ce4e5ad6f26","status":"active","text":"Microsatellite instability was the most frequent genetic marker in the additional clinical trials, accounting for 20 of 45 identified marker uses.","confidence":0.96,"contributors":[{"id":136,"public_id":"3c2apqe3ut","public_label":"Anonymous (3c2apqe3ut)","roles":["extraction"],"url":"https://sah.borca.ai/u/3c2apqe3ut"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/claims/cl_74d2209f35a3aff1dac44ce4e5ad6f26"},{"public_id":"cl_c04b5039f7f9a7950a0463d00ffc6ca1","status":"active","text":"Most additional trials enabled by comprehensive genomic profiling were phase 1 or phase 2 trials and involved metastatic disease.","confidence":0.94,"contributors":[{"id":136,"public_id":"3c2apqe3ut","public_label":"Anonymous (3c2apqe3ut)","roles":["extraction"],"url":"https://sah.borca.ai/u/3c2apqe3ut"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/claims/cl_c04b5039f7f9a7950a0463d00ffc6ca1"}],"concepts":[{"public_id":"co_068bf4004c9aed0b1dc0095f1d55f7c7","status":"active","name":"enrollment eligibility","description":"The criteria determining whether patients could enroll in the identified clinical trials.","types":["trial criterion"],"aliases":[],"contributors":[{"id":136,"public_id":"3c2apqe3ut","public_label":"Anonymous (3c2apqe3ut)","roles":["extraction"],"url":"https://sah.borca.ai/u/3c2apqe3ut"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_068bf4004c9aed0b1dc0095f1d55f7c7"},{"public_id":"co_3367263c10070497dbc59376265be794","status":"active","name":"comprehensive genomic profiling","description":"A cancer genomic testing approach represented in the abstract by FoundationOne CDx with 324 genes.","types":["testing approach"],"aliases":["CGP"],"contributors":[{"id":136,"public_id":"3c2apqe3ut","public_label":"Anonymous (3c2apqe3ut)","roles":["extraction"],"url":"https://sah.borca.ai/u/3c2apqe3ut"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_3367263c10070497dbc59376265be794"},{"public_id":"co_36d04913aa60f7ba94b23a505163bc88","status":"active","name":"Aggregate Analysis of ClinicalTrials.gov database","description":"The ClinicalTrials.gov-derived database used to identify relevant non-small cell lung cancer trials.","types":["database"],"aliases":["AACT database"],"contributors":[{"id":136,"public_id":"3c2apqe3ut","public_label":"Anonymous (3c2apqe3ut)","roles":["extraction"],"url":"https://sah.borca.ai/u/3c2apqe3ut"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_36d04913aa60f7ba94b23a505163bc88"},{"public_id":"co_39f06fc0959e42677d2bc5ed240d390c","status":"active","name":"genetic variant status","description":"A patient's genetic alteration status used to determine enrollment eligibility in some trials.","types":["biomarker status"],"aliases":[],"contributors":[{"id":136,"public_id":"3c2apqe3ut","public_label":"Anonymous (3c2apqe3ut)","roles":["extraction"],"url":"https://sah.borca.ai/u/3c2apqe3ut"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_39f06fc0959e42677d2bc5ed240d390c"},{"public_id":"co_43e95fd14d6fa98b0288713fa3c27985","status":"active","name":"FoundationOne CDx","description":"The 324-gene comprehensive genomic profiling test used as the larger panel in the comparison.","types":["genomic test"],"aliases":[],"contributors":[{"id":136,"public_id":"3c2apqe3ut","public_label":"Anonymous (3c2apqe3ut)","roles":["extraction"],"url":"https://sah.borca.ai/u/3c2apqe3ut"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_43e95fd14d6fa98b0288713fa3c27985"},{"public_id":"co_4622081c7da4e49f19fa9bd57214c892","status":"active","name":"Oncomine Dx Target Test","description":"The commercially available 23-gene comparator panel used against comprehensive genomic profiling.","types":["genomic test","comparator"],"aliases":[],"contributors":[{"id":136,"public_id":"3c2apqe3ut","public_label":"Anonymous (3c2apqe3ut)","roles":["extraction"],"url":"https://sah.borca.ai/u/3c2apqe3ut"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_4622081c7da4e49f19fa9bd57214c892"},{"public_id":"co_5d26096aa2d44f77c5b2ddab32be56b3","status":"active","name":"required genetic alterations","description":"Genetic changes listed in trial eligibility criteria as requirements for enrollment.","types":["eligibility criterion"],"aliases":[],"contributors":[{"id":136,"public_id":"3c2apqe3ut","public_label":"Anonymous (3c2apqe3ut)","roles":["extraction"],"url":"https://sah.borca.ai/u/3c2apqe3ut"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_5d26096aa2d44f77c5b2ddab32be56b3"},{"public_id":"co_74dbd012487ad3fd1f0058e37cf1cb3b","status":"active","name":"metastatic disease","description":"Disease severity category used to characterize additional clinical trials in the abstract.","types":["disease setting"],"aliases":[],"contributors":[{"id":136,"public_id":"3c2apqe3ut","public_label":"Anonymous (3c2apqe3ut)","roles":["extraction"],"url":"https://sah.borca.ai/u/3c2apqe3ut"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_74dbd012487ad3fd1f0058e37cf1cb3b"},{"public_id":"co_74f4105ce60cb9f01f721473df85befe","status":"active","name":"non-small cell lung cancer trials","description":"Clinical trials involving non-small cell lung cancer that were evaluated in the analysis.","types":["clinical trial set"],"aliases":["NSCLC trials"],"contributors":[{"id":136,"public_id":"3c2apqe3ut","public_label":"Anonymous (3c2apqe3ut)","roles":["extraction"],"url":"https://sah.borca.ai/u/3c2apqe3ut"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_74f4105ce60cb9f01f721473df85befe"},{"public_id":"co_99cd3c487141127d1a76a166f7061b44","status":"active","name":"phase 1 or 2","description":"Early clinical trial phases used to characterize most of the additional trials.","types":["trial phase"],"aliases":[],"contributors":[{"id":136,"public_id":"3c2apqe3ut","public_label":"Anonymous (3c2apqe3ut)","roles":["extraction"],"url":"https://sah.borca.ai/u/3c2apqe3ut"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_99cd3c487141127d1a76a166f7061b44"},{"public_id":"co_a6e9297969fc994fb9b772ffa1c31a3a","status":"active","name":"non-small cell lung cancer","description":"The cancer type for which clinical trial eligibility and access were analyzed.","types":["disease"],"aliases":["NSCLC"],"contributors":[{"id":136,"public_id":"3c2apqe3ut","public_label":"Anonymous (3c2apqe3ut)","roles":["extraction"],"url":"https://sah.borca.ai/u/3c2apqe3ut"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_a6e9297969fc994fb9b772ffa1c31a3a"},{"public_id":"co_aff9dc00a402bba663c172989a05dcfa","status":"active","name":"genetic markers","description":"Biomarkers used in eligibility criteria for the additional clinical trials.","types":["biomarker"],"aliases":[],"contributors":[{"id":136,"public_id":"3c2apqe3ut","public_label":"Anonymous (3c2apqe3ut)","roles":["extraction"],"url":"https://sah.borca.ai/u/3c2apqe3ut"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_aff9dc00a402bba663c172989a05dcfa"},{"public_id":"co_cf0b921caedaf212e71c671bc100a083","status":"active","name":"microsatellite instability","description":"A genetic marker reported as frequent among markers in the additional trials.","types":["genetic marker"],"aliases":[],"contributors":[{"id":136,"public_id":"3c2apqe3ut","public_label":"Anonymous (3c2apqe3ut)","roles":["extraction"],"url":"https://sah.borca.ai/u/3c2apqe3ut"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_cf0b921caedaf212e71c671bc100a083"},{"public_id":"co_f80408534c2a09fa76f93907b24ab6f1","status":"active","name":"additional clinical trials","description":"Trials potentially available to patients because comprehensive genomic profiling detects markers beyond the comparator panel.","types":["trial outcome"],"aliases":["incremental trials"],"contributors":[{"id":136,"public_id":"3c2apqe3ut","public_label":"Anonymous (3c2apqe3ut)","roles":["extraction"],"url":"https://sah.borca.ai/u/3c2apqe3ut"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_f80408534c2a09fa76f93907b24ab6f1"}],"external_ids":{"DOI":"10.1200/jco.2020.39.28_suppl.59","ArXiv":null,"PubMed":null,"PubMedCentral":null,"MAG":3199580546,"DBLP":null,"ACL":null},"open_access":{"is_open_access":false,"pdf_url":null,"landing_url":"https://sah.borca.ai/papers/240541392","source":null,"pdf_url_source":null,"license":null,"reason":"pdf_url_not_indexed"},"reference_availability":{"status":"unknown","references_indexed":false,"full_text_available":false,"full_text_source":null,"count_basis":"semantic_scholar_metadata","extraction_status":"not_applicable","reason":null},"source":{"provider":"episteme2","base_corpus":"semantic_scholar_dump","freshness_mode":"unknown","basis":["semantic_scholar_metadata","postgres_metadata"],"limits":["paper metadata is based on indexed upstream scholarly datasets","claims and concepts are available only for extracted papers","absence of claims or concepts means no extracted graph data is available in this response"],"status":"available","degraded":false,"degraded_reasons":[],"diagnostics":{"status":"available","degraded":false,"degraded_reasons":[],"metadata_status":"available","graph_status":"available","abstract_status":"available"},"source_flags":1},"paper_id":632250,"paper_uid":"62b22274-f88e-428c-a624-50ac4d7440e6","canonical_identity":{"paper_id":632250,"paper_uid":"62b22274-f88e-428c-a624-50ac4d7440e6","identity_status":"available","lookup_basis":"semantic_scholar_external_id","compatibility_path":"corpus_id"},"url":"https://sah.borca.ai/papers/240541392"}