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Tarlatamab for Small Cell Lung Cancer (DeLLphi-306 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 age within the country if it is older than 18 years).

Histologically or cytologically confirmed small-cell lung cancer (SCLC).

Must not have

Extensive-stage SCLC (ES-SCLC).

History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial will compare a drug to a placebo to see if it helps stop disease progression.

Who is the study for?

Adults diagnosed with limited-stage small-cell lung cancer (LS-SCLC) who have completed chemoradiotherapy without disease progression. Participants must be in good physical condition, not pregnant or planning to become pregnant, and willing to use contraception. Excluded are those with extensive-stage SCLC, recent heart issues, other cancers within 2 years (with exceptions), active infections, HIV/hepatitis, prior immune therapy complications, or organ transplants.

What is being tested?

The trial is testing the effectiveness of Tarlatamab compared to a placebo in preventing cancer progression after initial treatment for LS-SCLC. Patients will either receive Tarlatamab or a placebo and will be monitored for changes in their cancer status over time.

What are the potential side effects?

While specific side effects of Tarlatamab are not listed here, similar treatments may cause immune-related reactions, fatigue, nausea, infusion reactions and increased risk of infection. Side effects can vary from person to person.

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 age in my country.

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My lung cancer is confirmed to be small-cell type.

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I was treated for small cell lung cancer with chemo and radiation at the same time.

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My cancer did not worsen after my chemoradiotherapy, according to RECIST 1.1.

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Side effects from my cancer treatment have mostly gone away, except for hair loss.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My small cell lung cancer is in the extensive stage.

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I have not had a stroke or mini-stroke in the last 6 months.

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I have had severe reactions to immune therapy before.

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I have not had major surgery in the last 28 days.

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I am a woman who can have children and my pregnancy test was positive.

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I agree not to donate sperm during and for 132 days after treatment.

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My lung cancer has changed in type or has mixed features.

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I have a lung condition not caused by an infection.

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I have had a solid organ transplant.

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I am breastfeeding or plan to while on the study and for 72 days after the last dose.

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I have not been treated with drugs targeting the DLL3 pathway.

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I haven't had signs of a serious infection in the last week.

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I have not had a heart attack or severe heart failure in the last 6 months.

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I agree to use contraception or practice abstinence during and after the study.

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I received chemotherapy and chest radiotherapy separately for my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Side effects data

From 2024 Phase 1 trial • 23 Patients • NCT04885998

20%

Constipation

20%

Small cell lung cancer

20%

Anaemia

100%

80%

60%

40%

20%

Study treatment Arm

Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404 (EP)

Part 2 Dose Expansion Cohort: Tarlatamab Dose B + AMG 404 (SFU1)

Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404 (SFU1)

Part 1 Cohort 3: Tarlatamab Dose A/ Dose D + AMG 404 (EP)

Part 2 Dose Expansion Cohort: Tarlatamab Dose B + AMG 404 (EP)

Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404 (SFU1)

Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404 (EP)

Part 1 Cohort 3: Tarlatamab Dose A/ Dose D + AMG 404 (SFU1)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TarlatamabExperimental Treatment1 Intervention

Participants will receive tarlatamab on Cycle 1 Day 1, 8 and 15, and once every 2 weeks (Q2W) thereafter (cycle is 28 days).

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive placebo on Cycle 1 Day 1, 8 and 15, and Q2W thereafter (cycle is 28 days).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tarlatamab

2021

Completed Phase 1

~70

0 / 21Eligibility criteria met

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor

1,433 Previous Clinical Trials

1,394,742 Total Patients Enrolled

MDStudy DirectorAmgen

971 Previous Clinical Trials

938,914 Total Patients Enrolled

~267 spots leftby Oct 2029

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