CAMBRIDGE, Mass. — Zai Lab Limited has entered into a global clinical trial collaboration with Amgen Inc. to evaluate a new combination therapy for patients with extensive-stage small cell lung cancer, one of the most aggressive forms of the disease.
The partnership will study Zai Lab’s investigational antibody-drug conjugate, zocilurtatug pelitecan, alongside Amgen’s IMDELLTRA, a bispecific T-cell engager therapy. Amgen will sponsor and lead a global Phase 1b trial to assess the safety and effectiveness of the combination, while Zai Lab will retain ownership of its drug and supply it for the study.
“In combination, this dual-targeting strategy has the potential to increase the rate and deepen responses both systemically and, in the brain, address resistance pathways, and unlock new treatment paradigms for patients with small cell lung cancer,” said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. “These two approaches leverage complementary mechanisms — our ADC delivers a potent cytotoxic payload directly to DLL3-expressing tumor cells, while the T-cell engager is designed to activate T-cells by binding the same antigen and eliciting an immune response against the tumor.”
Zocilurtatug pelitecan targets DLL3, a protein commonly found in small cell lung cancer and other neuroendocrine tumors. The therapy combines a monoclonal antibody with a cancer-killing drug payload designed to selectively attack tumor cells while limiting damage to healthy tissue. The drug is being evaluated across multiple clinical studies, including trials in relapsed lung cancer and other solid tumors.
Zai Lab has reported encouraging early data from Phase 1 and 2 studies, showing strong response rates in heavily pretreated patients, including activity in brain metastases, along with a manageable safety profile.
Amgen’s IMDELLTRA, which targets the same DLL3 protein, is already approved in the U.S. for adults with extensive-stage small cell lung cancer whose disease has progressed after chemotherapy. The therapy works by engaging the immune system to attack cancer cells.
Small cell lung cancer accounts for about 15% of all lung cancer cases worldwide and is often diagnosed at an advanced stage. Patients typically face poor outcomes, with median survival around one year after initial treatment and limited options once the disease progresses.
Researchers believe combining the two therapies could enhance effectiveness by directly killing tumor cells while also activating the immune system, potentially improving outcomes for patients with few treatment options.
