Lung Cancer Clinical Trials with a Seamless Phase II/III Design: Systematic Review
Current lung cancer clinical research focuses on biomarkers and personalized treatment strategies. Adaptive clinical trial designs have gained significant ground due to their increased flexibility, compared to the conventional model of drug development from phase I to phase IV trials. One such adapt...
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2022-12-01
|
| Series: | Journal of Clinical Medicine |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2077-0383/11/23/7176 |
| _version_ | 1797462905353928704 |
|---|---|
| author | Dionysios Palermos Theodoros N. Sergentanis Maria Gavriatopoulou Panagiotis Malandrakis Theodora Psaltopoulou Evangelos Terpos Ioannis Ntanasis-Stathopoulos |
| author_facet | Dionysios Palermos Theodoros N. Sergentanis Maria Gavriatopoulou Panagiotis Malandrakis Theodora Psaltopoulou Evangelos Terpos Ioannis Ntanasis-Stathopoulos |
| author_sort | Dionysios Palermos |
| collection | DOAJ |
| description | Current lung cancer clinical research focuses on biomarkers and personalized treatment strategies. Adaptive clinical trial designs have gained significant ground due to their increased flexibility, compared to the conventional model of drug development from phase I to phase IV trials. One such adaptive approach is the seamless phase II/III design, which has been used to reduce the total sample size and drug development time. In this context, an algorithmic systematic search was conducted in MEDLINE (PUBMED), SCOPUS, EMBASE and Cochrane Central Register of Controlled Trials until 31 June 2022 in order to identify lung cancer trials of systematic treatments that have employed the seamless phase II/III methodology and to describe their characteristics. The search strategy yielded a total of 1420 records that were screened through their title and abstract; 28 eligible trials were included in the systematic review. Based on the study endpoints, the most common subtype included phase II/III trials with inefficacy/futility analyses (61%; 17/28), followed by dose escalation phase II/III trials (18%; 5/28), one multi-arm multi stage trial and 5 trials with other design (18%). Most eligible trials were open-label (71%; 20/27), included patients with non-small cell lung cancer (82%; 23/28), evaluated targeted therapies and/or immunotherapies (82%; 23/28) and recruited patients with advanced disease (89.3%; 25/28). In conclusion, the seamless phase II/III design is a feasible and suitable approach in lung cancer research, with distinct design subcategories according to study endpoints. |
| first_indexed | 2024-03-09T17:44:06Z |
| format | Article |
| id | doaj.art-fbc70191c2a04b7b93844f5a4585707f |
| institution | Directory Open Access Journal |
| issn | 2077-0383 |
| language | English |
| last_indexed | 2024-03-09T17:44:06Z |
| publishDate | 2022-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Journal of Clinical Medicine |
| spelling | doaj.art-fbc70191c2a04b7b93844f5a4585707f2023-11-24T11:24:10ZengMDPI AGJournal of Clinical Medicine2077-03832022-12-011123717610.3390/jcm11237176Lung Cancer Clinical Trials with a Seamless Phase II/III Design: Systematic ReviewDionysios Palermos0Theodoros N. Sergentanis1Maria Gavriatopoulou2Panagiotis Malandrakis3Theodora Psaltopoulou4Evangelos Terpos5Ioannis Ntanasis-Stathopoulos6Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, 11528 Athens, GreeceDepartment of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, 11528 Athens, GreeceDepartment of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, 11528 Athens, GreeceDepartment of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, 11528 Athens, GreeceDepartment of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, 11528 Athens, GreeceDepartment of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, 11528 Athens, GreeceDepartment of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, 11528 Athens, GreeceCurrent lung cancer clinical research focuses on biomarkers and personalized treatment strategies. Adaptive clinical trial designs have gained significant ground due to their increased flexibility, compared to the conventional model of drug development from phase I to phase IV trials. One such adaptive approach is the seamless phase II/III design, which has been used to reduce the total sample size and drug development time. In this context, an algorithmic systematic search was conducted in MEDLINE (PUBMED), SCOPUS, EMBASE and Cochrane Central Register of Controlled Trials until 31 June 2022 in order to identify lung cancer trials of systematic treatments that have employed the seamless phase II/III methodology and to describe their characteristics. The search strategy yielded a total of 1420 records that were screened through their title and abstract; 28 eligible trials were included in the systematic review. Based on the study endpoints, the most common subtype included phase II/III trials with inefficacy/futility analyses (61%; 17/28), followed by dose escalation phase II/III trials (18%; 5/28), one multi-arm multi stage trial and 5 trials with other design (18%). Most eligible trials were open-label (71%; 20/27), included patients with non-small cell lung cancer (82%; 23/28), evaluated targeted therapies and/or immunotherapies (82%; 23/28) and recruited patients with advanced disease (89.3%; 25/28). In conclusion, the seamless phase II/III design is a feasible and suitable approach in lung cancer research, with distinct design subcategories according to study endpoints.https://www.mdpi.com/2077-0383/11/23/7176seamless phase II/IIIlung canceradaptive designsclinical trial designs |
| spellingShingle | Dionysios Palermos Theodoros N. Sergentanis Maria Gavriatopoulou Panagiotis Malandrakis Theodora Psaltopoulou Evangelos Terpos Ioannis Ntanasis-Stathopoulos Lung Cancer Clinical Trials with a Seamless Phase II/III Design: Systematic Review Journal of Clinical Medicine seamless phase II/III lung cancer adaptive designs clinical trial designs |
| title | Lung Cancer Clinical Trials with a Seamless Phase II/III Design: Systematic Review |
| title_full | Lung Cancer Clinical Trials with a Seamless Phase II/III Design: Systematic Review |
| title_fullStr | Lung Cancer Clinical Trials with a Seamless Phase II/III Design: Systematic Review |
| title_full_unstemmed | Lung Cancer Clinical Trials with a Seamless Phase II/III Design: Systematic Review |
| title_short | Lung Cancer Clinical Trials with a Seamless Phase II/III Design: Systematic Review |
| title_sort | lung cancer clinical trials with a seamless phase ii iii design systematic review |
| topic | seamless phase II/III lung cancer adaptive designs clinical trial designs |
| url | https://www.mdpi.com/2077-0383/11/23/7176 |
| work_keys_str_mv | AT dionysiospalermos lungcancerclinicaltrialswithaseamlessphaseiiiiidesignsystematicreview AT theodorosnsergentanis lungcancerclinicaltrialswithaseamlessphaseiiiiidesignsystematicreview AT mariagavriatopoulou lungcancerclinicaltrialswithaseamlessphaseiiiiidesignsystematicreview AT panagiotismalandrakis lungcancerclinicaltrialswithaseamlessphaseiiiiidesignsystematicreview AT theodorapsaltopoulou lungcancerclinicaltrialswithaseamlessphaseiiiiidesignsystematicreview AT evangelosterpos lungcancerclinicaltrialswithaseamlessphaseiiiiidesignsystematicreview AT ioannisntanasisstathopoulos lungcancerclinicaltrialswithaseamlessphaseiiiiidesignsystematicreview |