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Monoclonal Antibodies

Tarlatamab + Durvalumab for Lung Cancer (DeLLphi-305 Trial)

Phase 3
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 18 years (or >= legal adult age within the country if it is older than 18 years).
Histologically or cytologically documented extensive-stage disease (American Joint Committee on Cancer, 2017, IV small-cell lung cancer (SCLC) [T any, N any, M1 a/b]), or T3 to T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial aims to see if adding tarlatamab to durvalumab improves overall survival compared to using durvalumab alone.

Who is the study for?
This trial is for adults with extensive-stage small-cell lung cancer who've had 3-4 cycles of specific chemo and a drug called durvalumab without their disease getting worse. They should be expected to live at least 12 more weeks, have resolved treatment side effects (except hair loss or tiredness), and good organ function. People with active brain metastases or poor physical status can't join.
What is being tested?
The study aims to see if adding tarlatamab to durvalumab improves overall survival compared to using durvalumab alone in patients who have already received initial treatments for extensive-stage small-cell lung cancer.
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, fatigue, skin issues, infusion reactions from the drugs being tested. The exact side effects will depend on how individuals react to tarlatamab and durvalumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at least 18 years old or the legal adult age in my country.
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My lung cancer is at an advanced stage and cannot be treated with just radiation.
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I've completed 3-4 cycles of specific chemotherapy for extensive-stage small cell lung cancer without the cancer getting worse.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Tarlatamab in Combination With DurvalumabExperimental Treatment2 Interventions
Participants will receive tarlatamab once every 2 weeks (Q2W) and durvalumab once every 4 weeks (Q4W).
Group II: Durvalumab AloneActive Control1 Intervention
Participants will receive durvalumab Q4W alone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3840

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,418 Previous Clinical Trials
1,382,322 Total Patients Enrolled
MDStudy DirectorAmgen
959 Previous Clinical Trials
928,237 Total Patients Enrolled
~367 spots leftby Sep 2027
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