All KCLG Medical trials are prospectively registered on ClinicalTrials.gov, conducted under GCP, and fully published — regardless of outcome.
Our active portfolio spans haematological malignancies, precision oncology, immunotherapy, and metabolic medicine — reflecting our commitment to broad evidence generation.
A Phase II randomised controlled trial investigating whether statin co-administration enhances the efficacy of ibrutinib in patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL). The biological rationale draws on the established cholesterol-dependent signalling pathways exploited by CLL cells — statins may potentiate BTK inhibition by disrupting lipid raft formation and downstream pro-survival signalling.
Primary Endpoint
Overall response rate at 6 months
Secondary Endpoints
PFS, OS, safety & tolerability, biomarker correlation
Setting
NHS Haematology centres
Design
Randomised, parallel-group, open-label
A biomarker-stratified Phase II adaptive platform trial matching patients to targeted therapeutic agents based on prospectively validated genomic and proteomic profiles. The platform design allows multiple investigational therapies to be assessed simultaneously within a shared infrastructure, accelerating evidence generation across tumour types.
Primary Endpoint
Biomarker-matched response rate per arm
Design
Adaptive platform, biomarker-stratified
Biomarker Panel
Genomic + proteomic profiling (prospectively validated)
Setting
Multi-site, NHS & academic centres
A Phase I/II dose-escalation and expansion study evaluating the safety, tolerability, and preliminary efficacy of a novel checkpoint inhibitor combination in patients with non-small cell lung cancer (NSCLC) and advanced melanoma. The study incorporates translational sub-studies to characterise tumour microenvironment changes during treatment.
Phase I Endpoint
Maximum tolerated dose / recommended Phase II dose
Phase II Endpoint
Objective response rate at 12 weeks
Indications
NSCLC (stage III/IV) · Advanced melanoma
Design
3+3 dose escalation → expansion cohorts
A large prospective observational cohort study examining the relationship between metabolic risk factors — including insulin resistance, lipid dysregulation, adiposity indices, and inflammatory markers — and cancer incidence and outcomes in a UK primary care population. Data will inform hypothesis-generation for future interventional trials.
Primary Outcome
Cancer incidence by metabolic risk stratum at 5 years
Population
UK primary care patients, age 40–75, metabolic risk factors
Data Sources
GP records · Hospital Episode Statistics · Cancer Registry linkage
Design
Prospective observational cohort · 5-year follow-up
We are committed to full publication of all trial results. The following represent selected outputs from KCLG Medical investigators.
KCLG Medical Haematology Group. Blood Advances, 2024. A translational analysis of statin-mediated cholesterol pathway disruption in ibrutinib-treated CLL cell lines and patient-derived samples, providing the mechanistic basis for KCLG-HAEM-01.
KCLG Medical Genomics Consortium. Nature Medicine, 2024. A methodological paper establishing the biomarker validation framework underlying KCLG-GEN-02, with prospective validation cohort data from 312 patients across eight tumour types.
KCLG Medical Epidemiology Group. The Lancet Oncology, 2023. A retrospective analysis of 48,000 UK primary care patients demonstrating independent associations between insulin resistance indices and risk of incident haematological malignancy, informing the design of KCLG-MET-04.
Every KCLG Medical trial is designed to the highest methodological standards — because the quality of our methods determines the reliability of our findings.
We offer flexible partnership structures to accommodate academic institutions, NHS Trusts, and industry sponsors.
We partner with academic research groups as co-investigators, providing operational, regulatory, and statistical infrastructure while supporting investigator-led study designs and independent academic authorship.
We work with NHS Trusts as a sponsoring or co-sponsoring CRO — providing site initiation, ethics and MHRA liaison, monitoring, data management, and investigator training.
For industry sponsors, we offer a full-service CRO model — from protocol development and regulatory strategy through to data lock, analysis, and publication — with an academic rigour that protects data integrity.
We support investigators who hold charity or grant funding by providing the regulatory, operational, and analytical infrastructure needed to convert a funded proposal into a running trial.
