US-based biopharmaceutical company Lantern Pharma has received regulatory approval for expanding its Phase II Harmonic clinical trial of an investigational new drug, LP-300, for treating non-small cell lung cancer (NSCLC).

The multicentre, open-label trial aims to assess the impact of LP-300 when combined with the standard-of-care chemotherapy regimen of pemetrexed and carboplatin.

It will enrol 90 patients in Japan and Taiwan who have never smoked. Of these, around 60 patients will be given LP-300 with chemotherapy, while the remaining 30 will receive only the standard of care chemotherapy.

Analysing progression-free survival (PFS) and overall survival (OS) in the patient population when administered LP-300 plus chemotherapy versus chemotherapy alone are the trial’s primary objectives.

The expansion into Japan and Taiwan is expected to hasten the accumulation of critical patient and response data for LP-300’s subsequent evaluation and development stages.

In Japan, the trial will be led by Dr Yashushi Goto, a physician and researcher of lung cancer at the National Cancer Center of Japan.

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Dr Goto said: “LP-300 represents a promising new treatment option for never-smokers with advanced NSCLC harboring driver mutations like EGFR, ALK, ROS1 and MET, who have limited choices after progressing on targeted therapies.

“The Harmonic trial brings renewed hope to those facing this devastating disease, especially in East Asia, where EGFR mutations are highly prevalent.”

LP-300 is being developed as a treatment for relapsed and inoperable primary adenocarcinoma of the lung.

The drug has been administered to more than 1,000 people across various clinical trials and has generally shown good tolerance.

It could also offer a significant therapeutic option for lung cancer patients in Japan and Taiwan, where many lung cancer diagnoses occur among never-smokers.

In September last year, Lantern Pharma dosed the first patient in a Phase I trial of its drug LP-184 to treat advanced solid tumours.