Amplia and Lilly Partner on Lung Cancer Combination Trial

Amplia Therapeutics has entered into a clinical trial collaboration with Eli Lilly and Company to evaluate a new targeted treatment combination for patients with advanced non-small cell lung cancer (NSCLC). The partnership will assess the safety and effectiveness of combining Amplia’s investigational focal adhesion kinase (FAK) inhibitor, narmafotinib, with Lilly’s investigational KRAS G12C inhibitor, olomorasib, in patients whose disease has progressed after initial treatment.

The companies announced that they have signed a Clinical Trial Collaboration and Supply Agreement (CTCSA) under which Amplia will lead a Phase 1b/2b clinical trial expected to begin in late 2026. The study will be conducted at multiple clinical sites across Australia and the United States.

Before finalizing the agreement, the two companies had already worked together to prepare an advanced draft of the clinical trial protocol. They will continue collaborating to complete the study design and associated clinical documentation before patient enrollment begins.

The planned study will evaluate the combination therapy as a second-line treatment for patients with advanced NSCLC carrying KRAS G12C mutations, a genetic alteration found in approximately 13% of non-small cell lung cancer cases. KRAS G12C mutations are also present in a smaller proportion of other solid tumors.

The collaboration represents an important strategic milestone for Amplia Therapeutics, expanding the clinical development of narmafotinib beyond pancreatic cancer and into one of the largest oncology markets worldwide.

According to the company, the global NSCLC market is currently valued at approximately US$31 billion and is projected to exceed US$60 billion by 2033, making it one of the fastest-growing segments in cancer therapeutics.

Amplia Chief Executive Officer and Managing Director Dr. Chris Burns said the partnership marks an exciting step in the development of narmafotinib.

He noted that both Amplia and other researchers have generated evidence suggesting that combining FAK inhibition with KRAS inhibition could improve treatment outcomes compared with KRAS-targeted therapy alone. Burns said the company is eager to explore the potential of pairing narmafotinib with olomorasib, which is currently being evaluated by Lilly in two global Phase III clinical trials for non-small cell lung cancer.

The collaboration also supports Amplia’s broader strategy of positioning narmafotinib as a combination therapy capable of enhancing the effectiveness of existing and emerging cancer treatments across multiple tumor types.

The company said the study builds on encouraging findings from its ACCENT clinical trial, where narmafotinib demonstrated a favorable tolerability profile when combined with chemotherapy. Researchers also observed promising early signs of efficacy, including encouraging response rates and survival outcomes.

One advantage of the agreement is its cost-efficient structure. Under the collaboration, Lilly will provide olomorasib for the study, allowing Amplia to advance the clinical program without bearing the full cost of supplying both investigational medicines.

Scientifically, the combination addresses one of the major challenges associated with KRAS-targeted therapies. While approved KRAS G12C inhibitors such as sotorasib and adagrasib have improved treatment options for patients with KRAS-mutated lung cancer, their clinical benefits are often limited by the development of drug resistance. Many patients experience disease progression within several months despite an initial response.

Researchers believe FAK plays a central role in the biological mechanisms that enable tumors to become resistant to KRAS G12C inhibitors. Activation of FAK supports cancer cell survival through multiple signaling pathways and contributes to changes in the tumor microenvironment that reduce the effectiveness of treatment.

By inhibiting FAK, narmafotinib is designed to suppress these resistance mechanisms, potentially allowing KRAS-targeted therapies to produce deeper and longer-lasting responses.

Olomorasib, Lilly’s next-generation KRAS G12C inhibitor, has demonstrated encouraging efficacy and safety results in earlier clinical studies and is currently advancing through two global Phase III registration trials for NSCLC.

If successful, the Phase 1b/2b study could establish a new targeted combination strategy for patients with advanced KRAS G12C-mutated lung cancer, a group that continues to face limited long-term treatment options despite recent advances in precision oncology.

For Amplia, the collaboration also strengthens its position in the oncology field by expanding narmafotinib into a significantly larger commercial opportunity while validating its potential as a versatile combination therapy capable of enhancing multiple targeted cancer treatments.