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OncoMatch/Clinical Trials/NCT05085028

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)

Is NCT05085028 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Pembrolizumab 25 MG/ML [Keytruda] for lung cancer, nonsmall cell.

Phase 3RecruitingImperial College LondonNCT05085028Data as of May 2026

Treatment: Pembrolizumab 25 MG/ML [Keytruda]REFINE-lung will test whether reduced pembrolizumab dose frequency after 6 months of standard treatment is safe and effective. Patients treated with 1st line pembrolizumab who are progression free and otherwise planning to continue therapy at 6 months will be initially randomised to control 6 weekly versus interventional 12 weekly therapy. If an interim analysis shows that the 12 weekly treatment is no less effective, subsequent patients will also be randomised to 9, 15 and 18 weekly treatment frequency arms. Patients who progress on a reduced frequency arm will be offered re-escalation to standard 6 weekly therapy.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Disease stage

Metastatic disease required

advanced Non small cell lung cancer

Prior therapy

Must have received: anti-PD-1 therapy (pembrolizumab) — first-line

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

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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