New combination therapy trial for lung cancer open to recruitment

UCLH has recruited the first participant to a new study testing an investigational combination of therapies in patients with advanced lung cancer.

The global study, known as BNT324-01 and sponsored by BioNTech SE, is testing the investigational drugs BNT324 and BNT327 in patients with advanced lung cancer.

UCLH medical oncologist Martin Forster, who is the UK Chief Investigator on the trial, said: “Lung cancer remains one of the most common cancers and sadly many patients have incurable disease when they are diagnosed.

“Despite recent improvements in treatment, the proportion of patients with advanced disease living beyond two years in still far too low and we are in desperate need of new drugs to improve outcomes for our patients.”

One of the study drugs, BNT324, is a ‘targeted chemotherapy’ designed to target a protein called B7-H3, which is found in large amounts in many cancer cells and deliver the chemotherapy directly to the cancer. BNT324 may help stop the growth of these cancer cells.

The other study drug, BNT327, is a form of immunotherapy, designed to block proteins called PD-L1 and VEGF-A, which play a role in immune control and the formation of blood vessels that can feed cancer cells. BNT327 may help reduce tumour growth and improve the effectiveness of cancer treatment.

This is the first time that these two drugs are being given together, and it is hoped that both drugs given at the same time may further reduce the growth of cancer cells.

Part 1 of the study will attempt to identify the best combination dose, while the second part will look at the safety and efficacy of the two drugs in more depth by assessing how they move into, through, and out of the body and how they affect participants’ quality of life.

“Both of these drugs are very innovative, and we hope they can be safely given together. As they work against the cancer in different ways, we hope they will complement each other and have a much bigger anti-cancer effect when combined, Professor Forster said.

Sam Barnett, Clinical Studies Manager from the NIHR UCLH Clinical Research Facility, said: “It’s a real credit to the whole NIHR UCLH CRF team that we have been able to achieve this milestone.

“Most importantly, we are grateful to the participants who give up so much of their precious time to help further our understanding of new investigational treatments.”

For more information view the study entry in the UCLH clinical trials database. If you wish to enquire about participation, please speak to your GP in the first instance.