Lantern Pharma Inc. (NASDAQ: LTRN) announced it has scheduled a Type C meeting with the FDA for mid-May 2026 to discuss proposed protocol amendments to its Phase 2 HARMONIC clinical trial evaluating LP-300 for lung cancer treatment.

The company reported preliminary data showing LP-300 demonstrated 8.3 months median progression-free survival in patients with EGFR L858R-mutant non-small cell lung cancer who had progressed after targeted therapy treatment. The data included 16 patients with this specific mutation, representing about 40% of all EGFR-mutant lung cancer cases globally.

Among the L858R patients who completed six treatment cycles of LP-300, the median progression-free survival reached 8.9 months. The company reported that LP-300 added no new toxicity to the standard carboplatin and pemetrexed chemotherapy combination.

Lantern plans to propose three protocol amendments to the FDA: focusing enrollment on EGFR L858R patients, converting to a single-arm study design, and increasing treatment cycles from six to eight. The amendments are based on emerging clinical data and the evolving treatment landscape for patients who have failed targeted therapy.

The L858R mutation is more common in never-smokers, who account for 35-40% of lung cancer cases in Asia compared to 15-17% in the United States and Europe. The company operates clinical sites in the United States, Japan and Taiwan.

LP-300 has not received FDA marketing approval and remains investigational. The clinical data referenced are preliminary with a data cutoff of April 13, 2026, according to the company's press release.