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Tarlatamab for Small Cell Lung Cancer (DeLLphi-306 Trial)

Yangzhou, China
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.

See full description
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.

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.
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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.
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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

Side effects data

From 2024 Phase 1 trial • 23 Patients • NCT04885998
57%
Decreased appetite
43%
Fatigue
43%
Dysgeusia
29%
Pyrexia
29%
Weight decreased
29%
Dizziness
29%
Insomnia
14%
Abdominal pain
14%
Dysphagia
14%
Nausea
14%
Gait disturbance
14%
Pain
14%
Cytokine release syndrome
14%
Alanine aminotransferase increased
14%
Hypokalaemia
14%
Dysarthria
14%
Prostatic obstruction
14%
Rash maculo-papular
14%
Confusional state
14%
Anaemia
14%
Sudden death
14%
Iron deficiency
14%
Pneumonia
14%
Encephalopathy
14%
Neurological decompensation
14%
Neurotoxicity
14%
Atrial fibrillation
14%
Constipation
14%
Gastric disorder
14%
Gastrooesophageal reflux disease
14%
Pancreatitis acute
14%
Upper respiratory tract infection
14%
Urinary tract infection
14%
Aspartate aminotransferase increased
14%
Weight loss poor
14%
Muscle mass
14%
Ataxia
14%
Headache
14%
Leukoencephalopathy
14%
Restless legs syndrome
14%
Tremor
14%
Agitation
14%
Urinary tract discomfort
14%
Cough
14%
Nasal congestion
14%
Deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404 (SFU1)
Part 1 Cohort 1: Tarlatamab Dose A/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)
Part 1 Cohort 3: Tarlatamab Dose A/ Dose D + AMG 404 (EP)
Part 2 Dose Expansion Cohort: Tarlatamab Dose B + AMG 404 (SFU1)
Part 2 Dose Expansion Cohort: Tarlatamab Dose B + AMG 404 (EP)

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

Find a Location

Closest Location:West Virginia University Health Sciences Center· Morgantown, WV· 164 miles

Who is running the clinical trial?

AmgenLead Sponsor
1,506 Previous Clinical Trials
1,432,588 Total Patients Enrolled
MDStudy DirectorAmgen
1,025 Previous Clinical Trials
951,884 Total Patients Enrolled
~267 spots leftby Oct 2029
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