509 Participants Needed

Tarlatamab for Small Cell Lung Cancer

(DeLLphi-304 Trial)

Recruiting at 243 trial locations
AC
Overseen ByAmgen Call Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment called tarlatamab to see if it helps patients live longer. Tarlatamab works by boosting the immune system to better fight cancer. The goal is to find out if this new treatment can improve overall survival for these patients.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before starting the study. Specifically, you must not use medications that affect certain liver enzymes (CYP3A) or transporters (P-gp, BCRP) within 7 to 28 days before the first dose, depending on the medication. Check with the study team to see if your current medications are affected.

What data supports the effectiveness of the drug Tarlatamab for Small Cell Lung Cancer?

Tarlatamab has shown promising activity in patients with small cell lung cancer whose disease had progressed after receiving another therapy, indicating its potential effectiveness. Additionally, Lurbinectedin, another component of the treatment, was approved by the FDA as a therapy for small cell lung cancer, supporting its use in this context.12345

Is Tarlatamab safe for humans?

Tarlatamab, also known as AMG 757, is being studied for its safety in treating small cell lung cancer. While it shows promise, there are still questions about its administration, and more research is needed to fully understand its safety profile.12678

What makes the drug Tarlatamab for Small Cell Lung Cancer unique?

Tarlatamab for Small Cell Lung Cancer is unique because it combines lurbinectedin, an oncogenic transcription inhibitor approved for SCLC, with topotecan, the only FDA-approved second-line treatment for SCLC, offering a novel combination approach for patients who have progressed after initial chemotherapy.156910

Research Team

M

MD

Principal Investigator

Amgen

Eligibility Criteria

Adults with relapsed/refractory Small Cell Lung Cancer (SCLC) who've had one platinum-based treatment can join. They need a life expectancy of at least 12 weeks, measurable disease, and good organ function. Exclusions include untreated brain metastases, recent serious heart issues or strokes, certain infections or treatments, pregnancy/breastfeeding individuals, and those unwilling to use contraception.

Inclusion Criteria

My small cell lung cancer has worsened or returned after treatment.
Participant has provided informed consent prior to initiation of any study specific activities/procedures.
I am at least 18 years old or considered an adult in my country.
See 5 more

Exclusion Criteria

I am a woman able to have children and agree to use birth control as required.
I've had side effects from immune therapy as outlined in the study.
Presence or history of viral infection based on criteria per protocol.
See 35 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either tarlatamab as an IV infusion or standard of care chemotherapy

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Lurbinectedin
  • Tarlatamab
  • Topotecan
Trial OverviewThe trial is testing Tarlatamab against standard chemotherapy drugs like Lurbinectedin, Topotecan, and Amrubicin in patients with SCLC that has come back after treatment. The goal is to see if Tarlatamab helps patients live longer compared to the usual treatments.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: TarlatamabExperimental Treatment1 Intervention
Participants will receive tarlatamab as an intravenous (IV) infusion.
Group II: Standard of CareActive Control3 Interventions
Participants will receive treatment per local standard of care (SOC).

Lurbinectedin is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Zepzelca for:
  • Metastatic small-cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy
🇪🇺
Approved in European Union as Zepzelca for:
  • Metastatic small-cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy

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

Findings from Research

Lurbinectedin, approved by the FDA in June 2020 as ZEPZELCA, is the first systemic therapy specifically for Small Cell Lung Cancer (SCLC), highlighting its significance in cancer treatment.
The drug works by inhibiting the transcription of genes related to tumor growth, which helps to suppress tumor-associated macrophages and alter the tumor environment, making it a promising option for SCLC patients.
Treatment of Small Cell Lung Cancer with Lurbinectedin: A Review.Rajput, PS., Khan, SR., Singh, P., et al.[2022]
Tarlatamab is a promising investigational treatment for small cell lung cancer, specifically targeting the delta-like ligand 3 protein, and has shown effectiveness in patients whose cancer progressed after previous therapies.
Despite its potential benefits, there are concerns regarding the administration challenges of tarlatamab, which may affect its acceptance by clinicians and patients.
Tarlatamab Shows Promise in SCLC.[2023]
Belotecan showed a higher objective response rate (33%) compared to topotecan (21%) and a significantly longer median overall survival (13.2 months vs. 8.2 months), suggesting it may be a more effective treatment for sensitive-relapsed small-cell lung cancer (SCLC).
Patients receiving belotecan also had a higher completion rate of treatment cycles (53% vs. 35%), indicating better tolerability and potential for improved patient adherence compared to topotecan.
A randomised phase 2b study comparing the efficacy and safety of belotecan vs. topotecan as monotherapy for sensitive-relapsed small-cell lung cancer.Kang, JH., Lee, KH., Kim, DW., et al.[2021]

References

Treatment of Small Cell Lung Cancer with Lurbinectedin: A Review. [2022]
Tarlatamab Shows Promise in SCLC. [2023]
A randomised phase 2b study comparing the efficacy and safety of belotecan vs. topotecan as monotherapy for sensitive-relapsed small-cell lung cancer. [2021]
A multi-center phase II study of weekly topotecan as second-line therapy for small cell lung cancer. [2013]
Paclitaxel/carboplatin/etoposide versus paclitaxel/topotecan for extensive-stage small cell lung cancer: a Minnie Pearl Cancer Research Network randomized, prospective phase II trial. [2015]
Lurbinectedin: First Approval. [2021]
Pooled Safety Analysis of Single-Agent Lurbinectedin in Patients With Advanced Solid Tumours. [2023]
Tarlatamab, a First-in-Class DLL3-Targeted Bispecific T-Cell Engager, in Recurrent Small-Cell Lung Cancer: An Open-Label, Phase I Study. [2023]
A randomised phase II study of the efficacy and safety of intravenous topotecan in combination with either cisplatin or etoposide in patients with untreated extensive disease small-cell lung cancer. [2013]
10.United Statespubmed.ncbi.nlm.nih.gov
Second-line treatment of small-cell lung cancer. [2019]