A Randomised Open-label Phase III Trial of REduced Frequency Pembrolizumab immuNothErapy for First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

Launched by IMPERIAL COLLEGE LONDON · Oct 18, 2021

Keywords

ClinConnect Summary

The REFINE-lung clinical trial is studying a new approach to treating advanced non-small cell lung cancer (NSCLC) using a medication called pembrolizumab. This trial aims to find out if giving pembrolizumab less frequently—every 12 weeks instead of every 6 weeks—after the first six months of treatment is safe and still effective for patients who are doing well. If early results show that the 12-week schedule works just as well, other patients may also be placed in groups receiving pembrolizumab every 9, 15, or even 18 weeks. If a patient’s cancer progresses while on a reduced schedule, they will have the option to return to the standard treatment frequency.

To participate, patients need to be at least 18 years old and have already received six months of pembrolizumab treatment, showing continued benefits without experiencing disease progression. They must also be willing to follow the study guidelines. The trial is currently recruiting participants of all genders. If you join the study, you can expect regular check-ups and monitoring to ensure your safety and the effectiveness of the treatment. It’s important to note that patients with new cancers or those who have not tolerated their treatment well cannot participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Written informed consent prior to initiation of any study procedures and willingness and ability to comply with the study schedule
• • Any patient ≥18yrs who has received 6 months of pembrolizumab treatment with or without chemotherapy for advanced Non small cell lung cancer who is planned to continue immunotherapy treatment because of continued benefit.
• Exclusion Criteria:
• • Disease progression or not tolerating treatment at 6 months into therapy
• • Clinician does not intend to continue immunotherapy
• • Any patient with a synchronous primary cancer. This includes any new cancer diagnoses or relapse of previously treated cancer since starting pembrolizumab treatment.
• • Any patient currently receiving an investigational agent and/or using an investigational device or has participated in a study of an investigational agent and/or used an investigational device within 28 days of randomisation.