Tarlatamab + YL201 for Lung Cancer
((DeLLphi-310) Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and tolerability of two drugs, tarlatamab and YL201, for treating extensive-stage small cell lung cancer (ES-SCLC). The goal is to identify the best dose combinations for these drugs, sometimes adding a third drug to boost the immune system's ability to fight cancer. Suitable candidates have ES-SCLC that has returned or worsened after standard treatments and have at least one measurable tumor. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that tarlatamab, when combined with YL201, has been studied to assess its safety and patient tolerance. Early results focus on patient response to the treatment and any side effects.
Interest also exists in how this combination interacts with anti-PD-L1 drugs like atezolizumab or durvalumab, which enhance the immune system's ability to fight cancer. Previous studies found that combining tarlatamab with a PD-L1 inhibitor was generally safe, with patients tolerating the treatment well.
Since the current trial is in an early stage, it primarily aims to determine a safe dose and observe patient reactions. While earlier studies provide some safety information, more data is being collected to ensure the treatment's safety for all participants.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Tarlatamab and YL201 for lung cancer because they offer a novel approach compared to traditional treatments like chemotherapy and targeted therapies. Tarlatamab is designed to target specific proteins on cancer cells, potentially enhancing the immune system's ability to fight tumors, while YL201 is being explored for its effectiveness when combined with this targeted approach. Additionally, the study is investigating how these drugs work with an anti-PD-L1 like atezolizumab or durvalumab, which are already known to boost immune response against cancer. This combination could provide a powerful new option for patients, especially if the drugs prove effective at lower doses with manageable side effects.
What evidence suggests that this trial's treatments could be effective for lung cancer?
Research shows that tarlatamab holds promise for treating lung cancer. Studies have found that tarlatamab can lower the risk of death by 40% and increase the average survival time by over five months compared to other treatments. When combined with chemotherapy or immunotherapy, tarlatamab has successfully shrunk tumors in 71% of patients. This trial studies the combination of tarlatamab with YL201, and early results are encouraging. Additionally, some participants will receive a combination that includes tarlatamab, YL201, and an immune-boosting drug like atezolizumab or durvalumab, which may enhance the treatment's effectiveness.13678
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
This trial is for adults with extensive stage small cell lung cancer (ES-SCLC). Participants must have had the disease progress after at least one platinum-based therapy, except for Part 3 where no prior treatment other than one cycle of specific drugs is allowed. They need at least one measurable lesion and good organ function.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Exploration
Multiple dose levels of YL201 will be explored in combination with tarlatamab administered intravenously (IV) at a fixed dose using one-step dosing
Dose Expansion
YL201 will be administered at the selected maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) in combination with tarlatamab administered IV at a fixed dose
Triplet Combination
YL201 will be administered at MTCD or RP2D in combination with tarlatamab and an anti-PD-L1 (atezolizumab or durvalumab) administered IV at a fixed dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Atezolizumab
- Durvalumab
- Tarlatamab
- YL201
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London
MediLink
Collaborator