Publication:

An analysis of studies on non-small cell lung cancer registered on clinical trials registry of India

Background Lung cancer is the most common cancer in males, of which non-small cell type is more prevalent. It is an active area of research owing to the limited available treatment modalities with several studies registered on CTRI. Objectives of current study was to analyse randomized control trials for non-small cell lung cancer registered on clinical trial registry India.

Methods Studies registered on CTRI were reviewed in this registry-based audit using the keywords lung cancer and non-small cell lung cancer. Parameters such as type of study, nature of intervention, phase of study, primary and secondary endpoints used, etc, were analysed and summarised using descriptive statistics in Microsoft Excel 365.

Results Out of 230 trials for lung cancer, 121 studied non-small cell lung cancer, of which 103 studies (85.1%) were interventional studies. Most common intervention under study was drug 97 studies (94.2%) followed by radiation 4 studies (3.3%). Majority of trials were phase 3, 48 trials (39.7%) and only 4 (3.3%) studies were phase 1. Five most common primary and secondary endpoints observed were survival, response rate, safety, pharmacokinetic data & quality of life. Maximum patients were in the advanced stage of cancer(52.1%) and pemetrexed (9.9%) was the most common drug used.

Conclusions We observed an increasing trend in studies registered on CTRI, with maximum studies in phase 3 with patients in the advanced stage of cancer having overall survival as the endpoint.