Micrograph of small cell lung cancer. Credit: Nephron / commons.wikimedia.org.

EpicentRx has dosed the first subject in the Phase III REPLATINUM clinical trial of RRx-001 in third-line and beyond extensive stage small cell lung cancer (SCLC) in China.

The international, multicentre trial is progressing at more than 50 sites in the US and China.

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It will assess the efficacy of RRx-001 plus a first-line platinum doublet compared to a platinum doublet in nearly 300 patients who were priorly treated with a platinum doublet and a checkpoint inhibitor.

The licencing partner of the company, SciClone Pharmaceuticals, is overseeing the trial in China.

Progression-free survival (PFS) and overall survival (OS) in study subjects are the primary endpoints of the trial.

A tumour-activated small molecule, RRx-001 is an investigational NLRP3 inhibitor.

It hinders the NLRP3 inflammasome and repolarises tumour-associated macrophages (TAMs).

The molecule is utilised for restoring sensitivity to chemotherapy. 

In 2020, EpicentRx and SciClone entered a licencing agreement for RRx-001 in Greater China.

RRx-001 has so far not been linked to any dose-limiting toxicities either administered alone or along with chemotherapy.

EpicentRx CEO Dr Tony Reid said: “The deck is stacked against patients with SCLC, a highly aggressive and metastatic cancer. 

“RRx-001 is a chemosensitizer, with the potential to help SCLC patients around the world by restoring sensitivity to first-line platinum-based chemotherapy.”

The REPLATINUM trial comes after the company successfully concluded the Phase II QUADRUPLE THREAT trial of RRx-001 in patients with late-line SCLC.

QUADRUPLE THREAT met the primary endpoint facilitating the commencement of the REPLATINUM trial.

In February this year, the company began the Phase I PIRATE trial of RRx-001 plus irinotecan and temozolomide to treat recurrent or progressive malignant solid and central nervous system tumours in paediatric patients.