← Back to Search

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).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 6 years

Awards & highlights

DeLLphi-306 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.Check my eligibility

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.See study design

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.

DeLLphi-306 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am at least 18 years old or the legal age in my country.

Select...

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

Select...

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

Select...

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

Select...

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

Select...

I am fully active or can carry out light work.

DeLLphi-306 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PFS as Determined by Blinded Independent Central Review (BICR)

Secondary outcome measures

Disease Control (DC) Rate

Duration of Response (DOR)

Incidence of Anti-tarlatamab Antibody Formation

+8 more

DeLLphi-306 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).

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor

1,372 Previous Clinical Trials

1,377,898 Total Patients Enrolled

MDStudy DirectorAmgen

917 Previous Clinical Trials

924,920 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process open for this trial?

"This clinical trial, which has been listed on the clinicaltrials.gov website since 1/27/2024 and was last updated on 10/31/2023 is not currently recruiting participants. 1599 other active studies are available for potential patients in lieu of this one."

Answered by AI

How many healthcare institutions are currently administering this test in the state?

"This clinical trial is open at 125 different sites. These locations span from Lebanon to Morristown and Bronx, as well as additional points of entry. To minimize the burden on patients, it is advised that they choose a clinic in close proximity to them for enrolment."

Answered by AI

What risks have been associated with Tarlatamab usage?

"Tarlatamab has been evaluated for safety by our team and is estimated to be a 3 on a scale of 1-3 due to the efficacy data gathered during Phase 3 trials as well as multiple rounds of supporting evidence."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)

2024. "Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06117774.

All > Lung Cancer Raleigh