NCT05085028: REFINE-Lung

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)

Recruiting now Phase 3 Last updated 7 March 2024

What this trial tests

Phase 3 trial testing Pembrolizumab 25 MG/ML [Keytruda] in Lung Cancer, Nonsmall Cell in 1,750 participants. Currently enrolling.

Timeline

23 June 2022

Primary endpoint
31 May 2027

31 May 2027

Quick facts

Lead sponsor	Imperial College London
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,750
Start date	23 June 2022
Primary completion	31 May 2027
Estimated completion	31 May 2027
Sites	37 locations across United Kingdom

Drugs / interventions tested

• Pembrolizumab 25 MG/ML [Keytruda] — full drug profile →

Conditions studied

• Lung Cancer, Nonsmall Cell — all drugs for Lung Cancer, Nonsmall Cell →

Sponsor

Imperial College London

Who can join

18 and older, any sex, with Lung Cancer, Nonsmall Cell. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. What is the optimal duration, dose and frequency for anti-PD1 therapy of non-small cell lung cancer?
   Kuah CY, Monfries R, Quartagno M, Seckl MJ, et al · · 2023 · cited 12× · PMID 37954230 · DOI 10.1177/17588359231210271
2. REFINE-Lung implements a novel multi-arm randomised trial design to address possible immunotherapy overtreatment.
   Ghorani E, Quartagno M, Blackhall F, Gilbert DC, et al · · 2023 · cited 12× · PMID 37142383 · DOI 10.1016/s1470-2045(23)00095-5
3. Drug resistance mechanism and reversal strategy in lung cancer immunotherapy.
   Xu Y, Liu Y, Ge Y, Li H, et al · · 2023 · cited 8× · PMID 37795038 · DOI 10.3389/fphar.2023.1230824
4. Outcomes of responders to PD-1/PD-L1 inhibitors who discontinue therapy after sustained disease control.
   Sharma H, Moturi KR, Pankratz VS, Yilmaz E, et al · · 2023 · cited 4× · PMID 37115270 · DOI 10.1007/s00432-023-04812-0
5. Survival in patients receiving reduced dose intensity of bevacizumab for unresectable hepatocellular carcinoma.
   Ball D, Nault JC, Vithayathil M, Allaire M, et al · · 2025 · cited 3× · PMID 40328959 · DOI 10.1038/s41698-025-00908-7
6. Immune Checkpoint Inhibitors in Metastatic Bladder and Other Solid Malignancies: How Long is Enough?
   Kumar V, Wei XX. · · 2023 · cited 3× · PMID 38993185 · DOI 10.3233/blc-230039
7. Dose optimization of immune checkpoint inhibitors for gastrointestinal malignancies.
   Alsina M, Beunza-Sola M, Fernández-Montes A, Padrón-Rodriguez B, et al · · 2026 · PMID 42180266 · DOI 10.1016/j.esmogo.2026.100338