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Monoclonal Antibodies

Tarlatamab for Small Cell Lung Cancer (DeLLphi-301 Trial)

Phase 2
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed relapsed/refractory SCLC
Participants who progressed or recurred following 1 platinum-based regimen and at least 1 other prior line of therapy.
Must not have
Female participants of childbearing potential with a positive pregnancy test assessed at screening and/or day 1 by a highly sensitive urine or serum pregnancy test.
Untreated or symptomatic brain metastases and leptomeningeal disease.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to a maximum of 24 months
Awards & highlights

Summary

This trial is testing a new cancer drug to see if it is safe and effective. The drug will be given to two different groups of people to see what dose is best. The study will also look at how well the drug works against cancer.

Who is the study for?
This trial is for adults over 18 with relapsed/refractory Small Cell Lung Cancer (SCLC) who have tried at least one platinum-based therapy and another treatment. They must have a life expectancy of at least 12 weeks, measurable cancer lesions, and be in fairly good health (ECOG status of 0 or 1). Participants with treated brain metastases may join if they meet certain criteria. Pregnant women, those planning to become pregnant, or breastfeeding are excluded, as well as anyone unwilling to use contraception.Check my eligibility
What is being tested?
The study tests two dose levels of Tarlatamab for safety and effectiveness against SCLC tumors. It's divided into parts: the first evaluates safety/effectiveness per RECIST 1.1 standards; the second assesses tumor response rate by independent review; the third looks at safety regarding reduced monitoring after initial doses.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones from treatments like Tarlatamab can include immune-related reactions such as inflammation in organs, fatigue, infusion reactions similar to allergic responses during drug administration, digestive issues like nausea or diarrhea, blood disorders affecting cell counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My small cell lung cancer has come back or didn't respond to treatment.
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My cancer returned or worsened after 1 platinum-based treatment and another therapy.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, as confirmed by a sensitive test.
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I have brain metastases or leptomeningeal disease that hasn't been treated or is causing symptoms.
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I have a lung condition not caused by an infection.
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I had severe reactions to previous immune therapy.
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I have not had major surgery in the last 4 weeks.
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I have not taken steroids or immunosuppressants in the last 7 days.
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I haven't had signs of a serious infection in the last week.
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I have had issues with my pituitary gland.
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I am not breastfeeding nor plan to while on the study and for 72 days after the last dose.
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I have previously been treated with tarlatamab.
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I agree not to donate sperm during and for 132 days after my last dose of tarlatamab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to a maximum of 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to a maximum of 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1 Only: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator
Part 1 Only: Serum Concentrations of Tarlatamab
Part 1 and Part 2 Only: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR)
+1 more
Secondary outcome measures
Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR)
Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator
Duration of Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR)
+10 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part 3: Modified Monitoring SubstudyExperimental Treatment1 Intervention
Participants will receive the selected target dose of Tarlatamab based on findings in Part 1 with reduced Cycle 1 monitoring requirements.
Group II: Part 2: Dose ExpansionExperimental Treatment1 Intervention
Participants will receive the selected target dose of Tarlatamab based on findings in Part 1.
Group III: Part 1: Tarlatamab Low DoseExperimental Treatment1 Intervention
Participants will receive the low dose of Tarlatamab.
Group IV: Part 1: Tarlatamab High DoseExperimental Treatment1 Intervention
Participants will receive the high dose of Tarlatamab.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy, immunotherapy, and targeted therapies. Chemotherapy drugs like etoposide and cisplatin work by damaging the DNA of cancer cells, causing them to die. Immunotherapy, such as anti-PD-1 or anti-PD-L1 therapies, boosts the immune system's ability to detect and kill cancer cells. Targeted therapies, like tarlatamab, specifically bind to proteins or antigens on cancer cells, leading to their destruction. These mechanisms are vital for SCLC patients as they help in choosing the most effective treatment, potentially improving survival rates and reducing side effects.

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,392 Previous Clinical Trials
1,380,898 Total Patients Enrolled
MDStudy DirectorAmgen
937 Previous Clinical Trials
927,045 Total Patients Enrolled

Media Library

Tarlatamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05060016 — Phase 2
Small Cell Lung Cancer Research Study Groups: Part 1: Tarlatamab Low Dose, Part 1: Tarlatamab High Dose, Part 2: Dose Expansion, Part 3: Modified Monitoring Substudy
Small Cell Lung Cancer Clinical Trial 2023: Tarlatamab Highlights & Side Effects. Trial Name: NCT05060016 — Phase 2
Tarlatamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05060016 — Phase 2
~20 spots leftby Oct 2024