{ "topic": { "stem": "DACOMITINIB_LUNG_AUTO_2", "name": "Dacomitinib in EGFR NSCLC (broader)", "ncts": [ "NCT03810807", "NCT01360554", "NCT03755102", "NCT04946968", "NCT01858389", "NCT06486142", "NCT01918761", "NCT04504071" ], "drug_patterns": [ "dacomitinib" ], "condition_patterns": [ "lung" ] }, "trials": [ { "gates": { "A_aact_exists": true, "B_drug_in_intvs": true, "C_condition_in_aact": true, "D_pmid_topic_match": true, "E_two_arms": false, "F_primary_outcome_known": true }, "extracted": { "nct": "NCT03810807", "aact_title": "Study of Dacomitinib and Osimertinib for Patients With Advanced EGFR Mutant Lung Cancer", "aact_acronym": "", "start_date": "2019-01-17", "primary_completion_date": "2025-12-15", "aact_intvs": [ "dacomitinib", "osimertinib" ], "aact_conditions": [ "metastatic non-small cell lung cancer" ], "pmid": "34140482", "pubmed_year": 2021, "pubmed_doi": "10.1038/s41467-021-23912-4", "aact_per_arm_counts": {}, "aact_primary_outcome_measure": "maximum tolerated dose", "aact_outcome_count_rows": [] } }, { "gates": { "A_aact_exists": true, "B_drug_in_intvs": true, "C_condition_in_aact": true, "D_pmid_topic_match": true, "E_two_arms": true, "F_primary_outcome_known": true }, "extracted": { "nct": "NCT01360554", "aact_title": "ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer", "aact_acronym": "ARCHER 1009", "start_date": "2011-06-16", "primary_completion_date": "2013-09-30", "aact_intvs": [ "dacomitinib (pf-00299804)", "active comparator (erlotinib)", "placebo erlotinib" ], "aact_conditions": [ "non-small cell lung cancer" ], "pmid": "26768165", "pubmed_year": 2016, "pubmed_doi": "10.1093/annonc/mdv593", "aact_per_arm_counts": { "BG000": 436, "BG001": 436 }, "aact_primary_outcome_measure": "Progression-Free Survival (PFS) Per Independent Radiologic Review.", "aact_outcome_count_rows": [ [ "OG001", "8.0" ], [ "OG000", "46.0" ], [ "OG001", "27.0" ], [ "OG000", "163.0" ], [ "OG001", "182.0" ], [ "OG000", "151.0" ], [ "OG001", "146.0" ], [ "OG000", "73.0" ], [ "OG001", "76.0" ], [ "OG000", "2.0" ] ] } }, { "gates": { "A_aact_exists": true, "B_drug_in_intvs": true, "C_condition_in_aact": true, "D_pmid_topic_match": false, "E_two_arms": false, "F_primary_outcome_known": true }, "extracted": { "nct": "NCT03755102", "aact_title": "A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progression on Osimertinib.", "aact_acronym": "", "start_date": "2018-11-21", "primary_completion_date": "2023-07-07", "aact_intvs": [ "dacomitinib", "osimertinib" ], "aact_conditions": [ "egfr gene mutation", "lung cancer", "lung cancer metastatic" ], "pmid": null, "aact_per_arm_counts": {}, "aact_primary_outcome_measure": "Overall Response Rate", "aact_outcome_count_rows": [] } }, { "gates": { "A_aact_exists": true, "B_drug_in_intvs": true, "C_condition_in_aact": true, "D_pmid_topic_match": false, "E_two_arms": false, "F_primary_outcome_known": true }, "extracted": { "nct": "NCT04946968", "aact_title": "Phase-2 Dacomitinib Study on Patients With EGFR-Driven Advanced Solid Tumours With Low EGFR-AS1 IncRNA Expr or Other Novel Emerging Biomarkers", "aact_acronym": "", "start_date": "2021-08-24", "primary_completion_date": "2027-04-30", "aact_intvs": [ "oral dacomitinib" ], "aact_conditions": [ "advanced solid tumours", "head and neck squamous cell carcinoma", "non-small cell lung cancer" ], "pmid": null, "aact_per_arm_counts": {}, "aact_primary_outcome_measure": "Objective Response Rate", "aact_outcome_count_rows": [] } }, { "gates": { "A_aact_exists": true, "B_drug_in_intvs": true, "C_condition_in_aact": true, "D_pmid_topic_match": true, "E_two_arms": true, "F_primary_outcome_known": true }, "extracted": { "nct": "NCT01858389", "aact_title": "A Study Of Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer", "aact_acronym": "", "start_date": "2013-07-31", "primary_completion_date": "2015-09-30", "aact_intvs": [ "dacomitinib", "dacomitinib" ], "aact_conditions": [ "non-small cell lung cancer" ], "pmid": "31858327", "pubmed_year": 2020, "pubmed_doi": "10.1007/s10637-019-00887-0", "aact_per_arm_counts": { "BG000": 16, "BG001": 22 }, "aact_primary_outcome_measure": "Best Overall Response (BOR) in Participants With T790M Mutation", "aact_outcome_count_rows": [ [ "OG000", "0.0" ], [ "OG000", "1.0" ], [ "OG000", "7.0" ], [ "OG000", "6.0" ], [ "OG000", "2.0" ], [ "OG000", "50.0" ], [ "OG000", "2.83" ], [ "OG000", "37.5" ], [ "OG001", "25.3" ], [ "OG000", "6.3" ] ] } }, { "gates": { "A_aact_exists": true, "B_drug_in_intvs": true, "C_condition_in_aact": true, "D_pmid_topic_match": false, "E_two_arms": false, "F_primary_outcome_known": true }, "extracted": { "nct": "NCT06486142", "aact_title": "EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study", "aact_acronym": "ERIS", "start_date": "2022-09-21", "primary_completion_date": "2028-09-30", "aact_intvs": [ "afatinib/dacomitinib", "osimertinib" ], "aact_conditions": [ "non-small cell lung cancer" ], "pmid": null, "aact_per_arm_counts": {}, "aact_primary_outcome_measure": "Progression-free survival (PFS)", "aact_outcome_count_rows": [] } }, { "gates": { "A_aact_exists": true, "B_drug_in_intvs": true, "C_condition_in_aact": true, "D_pmid_topic_match": false, "E_two_arms": false, "F_primary_outcome_known": true }, "extracted": { "nct": "NCT01918761", "aact_title": "Dacomitinib + Pemetrexed for Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)", "aact_acronym": "", "start_date": "2013-07-30", "primary_completion_date": "2016-09-15", "aact_intvs": [ "dacomitinib, pemetrexed" ], "aact_conditions": [ "non small cell lung cancer" ], "pmid": null, "aact_per_arm_counts": { "BG000": 5 }, "aact_primary_outcome_measure": "Dose Limiting Toxicities (DLTs)", "aact_outcome_count_rows": [ [ "OG000", "40.0" ], [ "OG000", "0.0" ] ] } }, { "gates": { "A_aact_exists": true, "B_drug_in_intvs": true, "C_condition_in_aact": true, "D_pmid_topic_match": true, "E_two_arms": false, "F_primary_outcome_known": true }, "extracted": { "nct": "NCT04504071", "aact_title": "Dacomitinib in Lung Cancer With Uncommon EGFR Mutations", "aact_acronym": "", "start_date": "2020-12-08", "primary_completion_date": "2022-12-15", "aact_intvs": [ "dacomitinib" ], "aact_conditions": [ "egf-r positive non-small cell lung cancer", "non-small cell lung cancer metastatic" ], "pmid": "35305596", "pubmed_year": 2022, "pubmed_doi": "10.1186/s12885-022-09409-3", "aact_per_arm_counts": {}, "aact_primary_outcome_measure": "Objective response rate （ORR）", "aact_outcome_count_rows": [] } } ], "n_total": 8, "n_pass_all": 2, "verdict": "VIABLE", "pass_rate": 0.25 }