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Predictors of exposure, therapeutic and adverse effects of targeted therapeutics used in the treatment of lung cancer.








Predictors of exposure, therapeutic and adverse effects of targeted therapeutics used in the treatment of lung cancer.


Ashley Hopkins


Flinders University






28 December 2018


Advanced cancers are difficult to treat. Afatinib, erlotinib, gefitinib, necitumumab and ramicurimab are important therapies for the treatment of advanced cancers. However, response and toxicity to these therapies is still highly unpredictable, with up to 70% of the patients who initiate them not responding and 95% experiencing some toxicity. Using the diverse range of data collected from clinical trials, it is possible to develop clinical tools that enable improved prediction of therapeutic and adverse outcomes of patients using afatinib, erlotinib, gefitinib, necitumumab or ramicurimab in the treatment of advanced cancers. Being able to identify the expected response and adverse effect profile may enable patients and clinicians to make better decisions regarding whether to commence, continue, discontinue or change dosing of these therapies.



[{ "PostingID": 1964, "Title": "BI-1200.23", "Description": "BIBW 2992 and BSC Versus Placebo and BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-LUNG 1)" },{ "PostingID": 2381, "Title": "BI-1200.22", "Description": "LUX Lung 2 Phase II Single Arm BIBW 2992 \"Afatinib\" in NSCLC With EGFR Activating Mutations" },{ "PostingID": 2382, "Title": "BI-1200.32", "Description": "BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation" },{ "PostingID": 2916, "Title": "BI-1200.34", "Description": "BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC)" },{ "PostingID": 3692, "Title": "BI-1200.43", "Description": "LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy" },{ "PostingID": 4533, "Title": "LILLY-14X-IE-JFCC", "Description": "A Randomized, Multicenter, Open-Label Phase 3 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Gemcitabine-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) (SQUIRE)" },{ "PostingID": 4540, "Title": "LILLY-I4T-MC-JVBA", "Description": "A Randomized, Double-Blind, Phase 3 Study of Docetaxel and Ramucirumab versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression after One Prior Platinum-Based Therapy (REVEL)" },{ "PostingID": 4949, "Title": "LILLY-I4X-MC-JFCL", "Description": "A Randomized, Multicenter, Open-Label, Phase 2 Study of Paclitaxel-Carboplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Paclitaxel-Carboplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)" },{ "PostingID": 4950, "Title": "LILLY-I4T-IE-JVBL", "Description": "An Open-label, Multicenter, Randomized, Phase 2 Study of a Recombinant Human Anti-VEGFR-2 Monoclonal Antibody, IMC-1121B in Combination With Platinum-based Chemotherapy Versus Platinum-based Chemotherapy Alone as First-line Treatment of Patients With Recurrent or Advanced Non-small Cell Lung Cancer (NSCLC)" },{ "PostingID": 4982, "Title": "BI-1200.123", "Description": "LUX-Lung 7: A Phase IIb Trial of Afatinib(BIBW2992) Versus Gefitinib for the Treatment of 1st Line EGFR Mutation Positive Adenocarcinoma of the Lung" },{ "PostingID": 5062, "Title": "LILLY-H3E-CR-JMIT", "Description": "A Randomised Phase 2 Trial of Pemetrexed and Gefitinib Versus Gefitinib as First Line Treatment for Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations" },{ "PostingID": 5063, "Title": "LILLY-I4T-JE-JVCG", "Description": "A Randomized, Double-Blind, Phase 2 Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression After One Prior Platinum-Based Therapy" },{ "PostingID": 14472, "Title": "ROCHE-YO25121", "Description": "A multicenter, open-label, randomized Phase III study to evaluate the efficacy and safety of Erlotinib (Tarceva®) versus gemcitabine/cisplatin as the first-line treatment for stage IIIB/IV non-small cell lung cancer (NSCLC) patients with mutations in the tyrosine kinase domain of epidermal growth factor receptor (EGFR) in their tumors." }]

Statistical Analysis Plan