Phase IV clinical trials for the treatment of non-small cell lung carcinoma (NSCLC): A systemic review from 2020-2025

Authors

• Yousif A. Kariri, From the Department of Clinical Laboratory Sciences (Kariri, Alqasmi), College of Applied Medical Sciences, Shaqra University, Shaqra, and from the Department of Health Rehabilitation Sciences (Alqhhtani), College of Applied Medical Sciences, Shaqra University, Shaqra, Riyadh, Kingdom of Saudi Arabia.
• Mohammed H. Alqasmi, From the Department of Clinical Laboratory Sciences (Kariri, Alqasmi), College of Applied Medical Sciences, Shaqra University, Shaqra, and from the Department of Health Rehabilitation Sciences (Alqhhtani), College of Applied Medical Sciences, Shaqra University, Shaqra, Riyadh, Kingdom of Saudi Arabia.
• Bijad S. Alqahtani, From the Department of Clinical Laboratory Sciences (Kariri, Alqasmi), College of Applied Medical Sciences, Shaqra University, Shaqra, and from the Department of Health Rehabilitation Sciences (Alqhhtani), College of Applied Medical Sciences, Shaqra University, Shaqra, Riyadh, Kingdom of Saudi Arabia.

Abstract

ABSTRACT Objective: To evaluate and provide evidence on drugs investigated in completed phase IV clinical trials for adult non-small cell lung carcinoma (NSCLC) therapy, primarily focusing on treatment objectives and adverse effects. Methods: Clinical research studies from January 2020 to January 2025 were systematically reviewed using the “ClinicalTrials.gov” database. The inclusion criteria focused on publicly available, relevant, and completed Phase IV studies limited to “Clinicaltrials.gov”, while those not meeting these specifications were excluded. As of 3 January 2025, a total of 7,541 Phase IV clinical trials were available on “ClinicalTrials.gov”, of which 121 were related to NSCLC. Results: Six of these clinical studies met the requirements for inclusion in the current investigation. The pharmacological agents investigated in these Phase IV trials were dacomitinib, lorlatinib, durvalumab, osimertinib, and a combination of rivaroxban and sotorasib. Treatment options for NSCLC remain limited due to its complex nature and frequent co-occurrence with other respiratory infections. Conclusion: The studies reviewed reported high rates of adverse events, alongside reduced subjective outcomes and faster response periods. This warrants for continuous research to develop safer and more efficient therapy methods for NSCLC patients. PROSPERO No.: CRD420251038011

Article Type

Systematic Review

First Page

1119

Last Page

1130

Recommended Citation

Kariri, Yousif A.; Alqasmi, Mohammed H.; and Alqahtani, Bijad S. (2025) "Phase IV clinical trials for the treatment of non-small cell lung carcinoma (NSCLC): A systemic review from 2020-2025," Saudi Medical Journal: Vol. 46: Iss. 10, Article 6.
DOI: https://doi.org/10.15537/smj.2025.46.10.20250385