Tarlatamab for Small Cell Lung Cancer

(DeLLphi-304 Trial)

Recruiting in Palo Alto (17 mi)

+243 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Amgen

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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.

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.

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.

Participant Groups

The 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.

Group I: Tarlatamab Experimental Treatment 1 Intervention

Participants will receive tarlatamab as an intravenous (IV) infusion.

Group II: Standard of Care Active Control 3 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

Research Locations Nearby Select from list below to view details:

University of South Alabama Mitchell Cancer Institute Mobile, AL

Alaska Oncology and Hematology LLC Anchorage, AK

University of Illinois Chicago Chicago, IL

Indiana University Indianapolis, IN

More Trial Locations

Who Is Running the Clinical Trial?

Amgen Lead Sponsor

References