TRACON Pharmaceuticals Inc announced that the National Cancer Institute (NCI) has initiated a randomized Phase 2 trial of TRC102 in combination with chemoradiation in patients with stage III non-squamous non-small cell lung cancer.
In a statement, the company said the open-label two-arm trial will enroll 78 patients and assess the benefit of adding TRC102 to the current standard of care treatment of pemetrexed, cisplatin, and radiation therapy followed by consolidative durvalumab.
The primary endpoint of the trial is progression-free survival (PFS) and the trial is designed to detect an improvement in PFS at one year from 56% to 75%. Enrollment is expected to begin in June 2022 and results are expected in 2024.
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“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 randomized trial of TRC102,” said TRACON CEO Dr. Charles Theuer.
"The initiation of a randomized clinical trial of TRC102 marks an important milestone for the program.”
The company noted that the randomized trial builds upon positive data from a Phase 1 trial of TRC102 in combination with chemoradiation presented at ASCO 2020 that demonstrated a 100% response rate in 15 patients with Stage IIIA or Stage IV non-squamous non-small cell lung cancer, including three patients who had a complete response to treatment.
The data compared favorably to historical data of the same combination of chemoradiation without TRC102 in advanced lung cancer from the PROCLAIM and the PACIFIC clinical trials.
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