200 Participants Needed

Tarlatamab + YL201 for Lung Cancer

((DeLLphi-310) Trial)

Recruiting at 22 trial locations
AC
Overseen ByAmgen Call Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

M

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

I am at least 18 years old or considered an adult by law.
My small cell lung cancer has worsened after platinum-based treatment.
I have at least one tumor that can be measured.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Atezolizumab
  • Durvalumab
  • Tarlatamab
  • YL201
Trial Overview The study tests the safety and tolerability of a new combination: Tarlatamab with YL201, with or without an anti-PD-L1 drug like Durvalumab or Atezolizumab. It aims to see how patients handle this mix of treatments.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Triplet Combination (Part 3)Experimental Treatment4 Interventions
Group II: Dose Exploration (Part 1)Experimental Treatment2 Interventions
Group III: Dose Expansion (Part 2)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials
1,508
Recruited
1,433,000+
Founded
1980
Headquarters
Thousand Oaks, USA
Known For
Human Therapeutics
Top Products
Enbrel, Prolia, Neulasta, Otezla
Robert A. Bradway profile image

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton profile image

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

Trials
1
Recruited
200+

Citations

NCT06898957 | Study of Tarlatamab in Combination With ...The primary objective of this study is to evaluate the safety and tolerability of tarlatamab in combination with YL201 with or without anti-PD-L1. Official ...
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40839303/
Efficacy outcomes between tarlatamab and real-world ...The study findings suggest that tarlatamab offers potential clinical benefits relative to comparator treatments.
A comparison of tarlatamab with real-world physicians’ ...For ORR, tarlatamab had an OR of 2.80 (95% CI: 1.44, 5.83) versus comparator therapies. Sensitivity analyses showed similar results, reaffirming the robustness ...
IMDELLTRA® SIGNIFICANTLY REDUCED RISK OF ...IMDELLTRA (tarlatamab-dlle) reduced the risk of death by 40% and significantly extended median overall survival (OS) by more than five months compared to ...
IMDELLTRA® SIGNIFICANTLY REDUCED RISK OF ...IMDELLTRA (tarlatamab-dlle) reduced the risk of death by 40% and significantly extended median overall survival (OS) by more than five months compared to ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40934933/
Safety and activity of tarlatamab in combination with a PD ...Safety and activity of tarlatamab in combination with a PD-L1 inhibitor as first-line maintenance therapy after chemo-immunotherapy in patients with extensive- ...
Study of Tarlatamab in Combination With YL201 With or ...The primary objective of this study is to evaluate the safety and tolerability of tarlatamab in combination with YL201 with or without ...
Study of Tarlatamab in Combination With YL201 With or ...The primary objective of this study is to evaluate the safety and tolerability of tarlatamab in combination with YL201 with or without anti-PD-L1.
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