Tarlatamab + ZL-1310 for Small Cell Lung Cancer

(DeLLphi-313 Trial)

This trial explores a new combination of treatments for small cell lung cancer (SCLC) to assess their safety and effectiveness together. Researchers are testing various doses of two experimental drugs, tarlatamab and ZL-1310, sometimes in combination with another drug called durvalumab. Suitable participants have small cell lung cancer that has recurred or worsened after standard treatment. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment combination.

The trial requires that you stop taking strong CYP3A4 or CPY2D6 inhibitors at least 14 days or 5 half-lives before starting the trial treatment. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Research has shown that ZL-1310, when combined with tarlatamab, is generally safe, as patients in earlier studies usually tolerated the treatment well. ZL-1310 has also demonstrated promising results against small cell lung cancer, indicating both effectiveness and safety.

For tarlatamab, studies have examined its mechanism in the body and helped establish safe doses for patients with small cell lung cancer. Researchers have also studied the safety of combining tarlatamab with durvalumab, a known treatment for some lung cancers, which provides additional reassurance about its safety.

Researchers are excited about the combination of tarlatamab and ZL-1310 for treating small cell lung cancer because these treatments harness the power of cutting-edge immunotherapy. Tarlatamab is a bispecific T-cell engager, which means it helps direct the body's immune system to target and attack cancer cells more effectively. ZL-1310 works alongside tarlatamab, potentially enhancing its effectiveness by optimizing dosing levels for the best patient outcomes. Additionally, the trial explores a triplet combination with durvalumab, an anti-PD-L1 agent, which could offer a synergistic boost to the immune response against cancer. This approach represents a new frontier in cancer treatment, aiming to improve outcomes for patients who have limited options with current therapies.

Research has shown that tarlatamab may assist patients with small cell lung cancer (SCLC) by enabling the immune system's T-cells to locate and attack cancer cells. In this trial, participants will receive different treatment combinations. One arm will explore multiple dose levels of ZL-1310 combined with tarlatamab. Another arm will administer ZL-1310 at the selected maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) with tarlatamab. Additionally, a third arm will study the combination of ZL-1310 and tarlatamab with durvalumab, a therapy that aids the immune system in fighting cancer. Early studies showed promising results for these combinations, which are being studied for their potential to enhance the body's immune response against cancer.¹²³⁶⁷