Tarlatamab for Small Cell Lung Cancer
(DeLLphi-315 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method of administering tarlatamab, a potential drug, to individuals with small cell lung cancer that has recurred after chemotherapy. The goal is to determine if administering the treatment as a subcutaneous injection is as effective as intravenous delivery. The trial seeks participants whose lung cancer has returned after one round of platinum-based chemotherapy and who can perform everyday activities without major issues. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study showed that tarlatamab, administered as an injection under the skin, had a good safety record. Patients with advanced small cell lung cancer tolerated it well, with only 13% experiencing severe side effects related to the treatment. Dosing interruptions were few, and no deaths occurred.
In contrast, earlier studies found safety concerns with tarlatamab given through an IV. Specifically, 57% of patients experienced cytokine release syndrome (CRS), a condition where the immune system releases too many proteins into the blood too quickly. This can be serious, so monitoring for symptoms is crucial.
Overall, both forms of tarlatamab have undergone study. While the injection under the skin appears to have a safer profile, the IV form carries certain risks that should be discussed with healthcare providers.12345Why do researchers think this study treatment might be promising for small cell lung cancer?
Tarlatamab is unique because it targets small cell lung cancer cells by connecting them with the body's T-cells to help destroy the cancer, a mechanism known as a bispecific antibody approach. Most current treatments for small cell lung cancer, like chemotherapy, attack all rapidly dividing cells, which can also harm healthy cells and cause significant side effects. Tarlatamab is being tested in two forms: a subcutaneous (SC) injection and an intravenous (IV) infusion, offering flexibility in how patients receive the treatment. Researchers are excited because this targeted method could mean fewer side effects and improved effectiveness compared to traditional therapies.
What evidence suggests that tarlatamab might be an effective treatment for small cell lung cancer?
Research has shown that Tarlatamab effectively fights tumors and improves survival rates in patients with small cell lung cancer (SCLC). Studies have found that it increases survival by about 10% at both two and three years. In this trial, participants will receive Tarlatamab either via subcutaneous (SC) injection or intravenous (IV) infusion. Tarlatamab is commonly used as a second option when the first treatment fails. When combined with other treatments, it has a 71% success rate in reducing or eliminating cancer. The FDA has approved Tarlatamab, confirming its effectiveness for certain conditions.26789
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 that has come back after treatment with platinum-based chemotherapy. Participants should be in generally good health aside from their cancer.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Tarlatamab via subcutaneous injection or intravenous infusion
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tarlatamab
Trial Overview
The study compares two ways of giving the drug tarlatamab—by injection under the skin (subcutaneous) versus through a vein (intravenous)—to see if they work similarly and are safe for people whose cancer returned after initial chemo.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive Tarlatamab via SC injection
Participants will receive Tarlatamab via IV infusion
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
Citations
Efficacy outcomes between tarlatamab and real-world ...
Tarlatamab, a … showed durable response with promising survival outcomes in patients with previously treated small cell lung cancer
2.
cancernetwork.com
cancernetwork.com/view/tarlatamab-plus-chemo-io-regimens-are-safe-elicit-responses-in-es-sclcTarlatamab Plus Chemo/IO Regimens Are Safe, Elicit ...
Tarlatamab plus chemo/IO showed a 71% objective response rate and promising safety for patients with ES-SCLC in the DeLLphi-303 study.
Real-world multi-institution analysis of tarlatamab in ...
Tarlatamab has revolutionized the management of small cell lung cancer (SCLC) and is now a standard of care second-line therapy. Adoption of tarlatamab after ...
4.
oncologynewscentral.com
oncologynewscentral.com/drugs/info/fda-approves-tarlatamab-for-small-cell-lung-cancerFDA Approves Tarlatamab for Small Cell Lung Cancer
OS at 2 years and at 3 years was improved by about 10%, with a 3-year OS of 56%. These are numbers that compare favorably to historical outcomes ...
Tarlatamab for Patients with Previously Treated Small-Cell ...
Tarlatamab, administered as a 10-mg dose every 2 weeks, showed antitumor activity with durable objective responses and promising survival ...
Real-World Outcomes of Tarlatamab in Small Cell ...
Tarlatamab showed promising antitumor activity and safety in the phase 2 DeLLphi-301 study in the third-line or later treatment settings for ES-SCLC.
About IMDELLTRA® for SCLC: Clinical Data & Mechanism of ...
IMDELLTRA ® (tarlatamab-dlle) is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on ...
FDA GRANTS FULL APPROVAL TO AMGEN'S ...
Global Confirmatory Phase 3 DeLLphi-304 Trial Showed IMDELLTRA Reduced Risk of Death by 40% Compared to Chemotherapy.
9.
oncologynewscentral.com
oncologynewscentral.com/drugs/monograph/188775-324026/tarlatamab-dlle-intravenousTarlatamab-dlle: uses, dosing, warnings, adverse events, ...
In the pooled safety population, CRS occurred in 57% (268 out of 473) of patients who received tarlatamab-dlle, including 39% last dose.[1]
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