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...
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Gespeichert in:

Autor*in:	Dionysios Palermos [verfasserIn] Theodoros N. Sergentanis [verfasserIn] Maria Gavriatopoulou [verfasserIn] Panagiotis Malandrakis [verfasserIn] Theodora Psaltopoulou [verfasserIn] Evangelos Terpos [verfasserIn] Ioannis Ntanasis-Stathopoulos [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2022

Schlagwörter:	seamless phase II/III lung cancer adaptive designs clinical trial designs

Übergeordnetes Werk:	In: Journal of Clinical Medicine - MDPI AG, 2013, 11(2022), 23, p 7176
Übergeordnetes Werk:	volume:11 ; year:2022 ; number:23, p 7176

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.3390/jcm11237176

Katalog-ID:	DOAJ085739685

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author	Dionysios Palermos
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topic_title	Lung Cancer Clinical Trials with a Seamless Phase II/III Design: Systematic Review seamless phase II/III lung cancer adaptive designs clinical trial designs
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title	Lung Cancer Clinical Trials with a Seamless Phase II/III Design: Systematic Review
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author_browse	Dionysios Palermos Theodoros N. Sergentanis Maria Gavriatopoulou Panagiotis Malandrakis Theodora Psaltopoulou Evangelos Terpos Ioannis Ntanasis-Stathopoulos
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title_sort	lung cancer clinical trials with a seamless phase ii/iii design: systematic review
title_auth	Lung Cancer Clinical Trials with a Seamless Phase II/III Design: Systematic Review
abstract	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.
abstractGer	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.
abstract_unstemmed	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.
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title_short	Lung Cancer Clinical Trials with a Seamless Phase II/III Design: Systematic Review
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Lung Cancer Clinical Trials with a Seamless Phase II/III Design: Systematic Review

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