The National Care Institute (NCI) announced its part in a “pragmatic” Phase III clinical trial investigating a two-drug combination to treat patients with advanced non-small cell lung cancer (NSCLC).

NCI, part of the National Institutes of Health (NIH) in the US, has helped with the launch of the Pragmatica-Lung Study but is yet to recruit patients. Due to the NIH and FDA efforts to modernise clinical trials, the study uses a pragmatic design with the aim to reduce as many burdens as possible that prevent people from joining clinical trials.

A pragmatic clinical trial has fewer and simpler eligibility criteria compared to traditional clinical trials. These trials are designed to evaluate the effectiveness of an intervention in real-life conditions, producing more generalised results, whereas traditional trials test interventions in a controlled setting.

In addition, the Pragmatica-Lung Study will allow the participation of people that have a lower function performance in their daily life, which is often an exclusion criterion in many trials.

NCI director Dr Monica Bertagnolli said: “Pragmatica-Lung, with its critical public and private partnerships, reflects the innovative approaches NCI is taking to achieve the Cancer Moonshot goals, including reducing the cancer death rate by 50% within the next 25 years.”

The Phase III trial (NCT05633602) will enrol 700 patients with stage four or recurrent NSCLC who previously received immunotherapy and chemotherapy. The study will investigate the combination treatment of Eli Lilly’s Cyramza (ramucirumab) and Merck’s Keytruda (pembrolizumab) compared to the standard of treatment.

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Because both Cyramza and Keytruda are approved by the FDA and the side effects are well known, the trial designers removed many of the extra tests, data collections and secondary trial measures that are often included in clinical trials.

As such the study will primarily focus on the side effects related to the two-drug combination – reducing the burden on both investigators and participants.

The primary endpoint of the trial will measure the overall survival from the randomisation to the date of death due to any cause, which will be assessed for up to three years. The study is expected to complete the enrolment by the end of 2025.

The institute hopes that the pragmatic approach towards clinical trials will simplify trials and make them less burdensome to patients and investigators, as well as accrue study participants faster that are more representative of the real-world patient population.

The Pragmatica-Lung study is sponsored by the NCI and led by the SWOG Cancer Research Network in collaboration with the Alliance for Clinical Trials in Oncology.