Tracon Pharmaceuticals has announced the commencement of a Phase II clinical trial of TRC102 (methoxyamine) plus chemoradiation in stage III non-squamous non-small cell lung cancer (NSCLC) patients.
It will have 78 subjects with enrolment anticipated to start in June this year. The trial results are expected in 2024. The trial is sponsored by the National Cancer Institute (NCI) in the US.
TRC102 is a small-molecule deoxyribonucleic acid (DNA) base excision repair pathway inhibitor.
The randomised, open-label, two-arm trial will evaluate the benefit of combining TRC102 with the current standard of care therapy of pemetrexed, cisplatin and radiation therapy followed by consolidative durvalumab.
Progression-free survival (PFS) is the trial’s primary endpoint while it intends to identify PFS improvement from 56% to 75% at one year.
The latest trial is supported by positive results from a Phase I trial of TRC102 plus chemoradiation.
In the trial, the combination treatment showed a 100% response rate in 15 individuals with Stage IIIA or Stage IV non-squamous NSCLC with three subjects demonstrating a complete response.
These results were comparable to historical data from the PROCLAIM and the PACIFIC trials, which analysed the same combination of chemoradiation without TRC102 to treat advanced lung cancer.
Tracon Pharma president and CEO Charles Theuer said: “We are pleased by the continued support of the National Cancer Institute for the development of TRC102 through our Cooperative Research and Development Agreement (CRADA), including sponsorship of the initial randomised trial of TRC102.
“The initiation of a randomised clinical trial of TRC102 marks an important milestone for the programme.”
At present, TRC102 is being analysed in various Phase I and Phase II trials, which are sponsored by the National Cancer Institute under a Cooperative Research and Development Agreement.
In April 2019, the company terminated Phase III TAPPAS trial of TRC105 in combination with Votrient (pazopanib) to treat patients with advanced or metastatic angiosarcoma.