Amplia Therapeutics Signs Clinical Trial Collaboration With Eli Lilly To Study New Combination Therapy For Advanced Lung Cancer

Amplia Therapeutics Limited has entered into a Clinical Trial Collaboration and Supply Agreement (CTCSA) with Eli Lilly & Company to evaluate a new targeted treatment approach for patients with advanced non-small cell lung cancer (NSCLC). The collaboration will assess the safety and efficacy of combining Amplia's investigational FAK inhibitor, narmafotinib, with Lilly's investigational KRAS G12C inhibitor, olomorasib, as a second-line treatment for patients whose disease has progressed after earlier therapy. The Phase 1b/2b clinical trial is expected to begin in late 2026 at sites across Australia and the United States.

Under the agreement, Amplia will sponsor and conduct the clinical study, while Lilly will provide olomorasib for the trial. Before signing the collaboration agreement, both companies worked together to develop an advanced draft of the study protocol and will continue working together to finalize the protocol and other clinical documents. Amplia CEO and Managing Director Dr. Chris Burns said the partnership represents an important step in the development of narmafotinib, adding that previous research has shown encouraging potential for combining FAK inhibition with KRAS inhibition to improve treatment outcomes.

The collaboration also supports Amplia's strategy of positioning narmafotinib as a combination therapy that can enhance the effectiveness of existing and investigational cancer treatments. The upcoming study builds on positive findings from the company's ACCENT clinical trial, where narmafotinib demonstrated no significant additional tolerability burden when combined with chemotherapy while also showing encouraging signs of improved treatment response and patient survival.

The trial will expand narmafotinib's clinical development beyond pancreatic cancer into non-small cell lung cancer, significantly increasing its potential market opportunity. The global NSCLC market is currently valued at around US$31 billion and is projected to exceed US$60 billion by 2033. KRAS G12C mutations are present in approximately 13% of NSCLC patients and in about 1% to 3% of patients with other solid tumors, making it an important target for new precision therapies. Lilly's supply of olomorasib will also allow Amplia to advance the program in a cost-efficient manner.

The scientific rationale for the study is based on the limitations of currently approved KRAS G12C inhibitors such as sotorasib and adagrasib. While these medicines have improved treatment options for patients with KRAS G12C-mutant NSCLC after prior therapy, many patients eventually develop resistance, resulting in relatively short progression-free survival. Researchers believe that combining olomorasib with narmafotinib could help overcome these resistance mechanisms and deliver longer-lasting clinical benefits.

Olomorasib is a next-generation, highly selective KRAS G12C inhibitor that has demonstrated encouraging safety and efficacy in earlier studies and is currently being evaluated in two global Phase 3 clinical trials for NSCLC. At the same time, growing research has identified Focal Adhesion Kinase (FAK) as a key driver of resistance to KRAS G12C-targeted therapies. By blocking FAK, narmafotinib may help reduce tumor resistance, improve the durability of treatment responses, and enhance the overall effectiveness of KRAS G12C inhibition. The announcement was approved for release by the Boards of Amplia Therapeutics and Eli Lilly & Company.