Tarlatamab for Small Cell Lung Cancer
(DeLLphi-304 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?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either tarlatamab as an IV infusion or standard of care chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Lurbinectedin
- Tarlatamab
- Topotecan
Lurbinectedin is already approved in United States, European Union for the following indications:
- Metastatic small-cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy
- 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
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