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Tarlatamab for Small Cell Lung Cancer (DeLLphi-304 Trial)
Phase 3
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing a new treatment called tarlatamab to see if it helps patients live longer. Tarlatamab works by boosting the immune system to better fight cancer. The goal is to find out if this new treatment can improve overall survival for these patients.
Who is the study for?
Adults with relapsed/refractory Small Cell Lung Cancer (SCLC) who've had one platinum-based treatment can join. They need a life expectancy of at least 12 weeks, measurable disease, and good organ function. Exclusions include untreated brain metastases, recent serious heart issues or strokes, certain infections or treatments, pregnancy/breastfeeding individuals, and those unwilling to use contraception.
What is being tested?
The trial is testing Tarlatamab against standard chemotherapy drugs like Lurbinectedin, Topotecan, and Amrubicin in patients with SCLC that has come back after treatment. The goal is to see if Tarlatamab helps patients live longer compared to the usual treatments.
What are the potential side effects?
Possible side effects from Tarlatamab may include immune-related reactions affecting organs or infusion responses similar to allergies. Standard chemo could cause fatigue, nausea, hair loss and increased risk of infection due to low blood cell counts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2024 Phase 1 trial • 23 Patients • NCT0488599871%
Cytokine release syndrome
43%
Anaemia
29%
Vomiting
29%
Fatigue
29%
Neutropenia
29%
Upper respiratory tract infection
29%
Nausea
29%
Thrombocytopenia
14%
Oral fungal infection
14%
Atrioventricular block first degree
14%
Constipation
14%
Dry mouth
14%
Hypokalaemia
14%
Diarrhoea
14%
Infusion related reaction
14%
Mouth ulceration
14%
Hypomagnesaemia
14%
Acute respiratory distress syndrome
14%
Decreased appetite
14%
Pyrexia
14%
COVID-19
14%
Hypoalbuminaemia
14%
Hyponatraemia
14%
Flank pain
14%
Myalgia
14%
Dry skin
14%
Hypertension
14%
Oropharyngeal pain
14%
Dysgeusia
14%
Abdominal distension
14%
Sinus arrhythmia
14%
Cough
14%
Dizziness
14%
Hyperglycaemia
14%
Vitamin D deficiency
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 2 Dose Expansion Cohort: Tarlatamab Dose B + AMG 404 (SFU1)
Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404 (EP)
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 1: Tarlatamab Dose A/Dose B + AMG 404 (SFU1)
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
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TarlatamabExperimental Treatment1 Intervention
Participants will receive tarlatamab as an intravenous (IV) infusion.
Group II: Standard of CareActive Control3 Interventions
Participants will receive treatment per local standard of care (SOC).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tarlatamab
2021
Completed Phase 1
~70
Find a Location
Who is running the clinical trial?
AmgenLead Sponsor
1,433 Previous Clinical Trials
1,394,633 Total Patients Enrolled
MDStudy DirectorAmgen
971 Previous Clinical Trials
938,805 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman able to have children and agree to use birth control as required.I've had side effects from immune therapy as outlined in the study.I have not had a heart attack or severe heart failure in the last year.I haven't needed antibiotics for an infection in the last week.I am currently on a cancer treatment like chemotherapy.I have had a stroke or mini-stroke in the last year.I am a man who will use birth control or abstain from sex while on tarlatamab and for 132 days after.I haven't had cancer treatment in the last 3 weeks, except as allowed.I haven't taken steroids or immunosuppressants in the last 7 days.I have brain metastases but meet the specific exceptions.I haven't had any other cancer in the last 2 years, except for types allowed in the study.I have a lung condition not caused by an infection.I have reached the maximum safe dose of heart-affecting drugs from previous treatments.My small cell lung cancer has worsened or returned after treatment.My cancer has spread to the lining of my brain and spinal cord.I have been treated with a drug targeting the DLL3 pathway before.I haven't taken any strong medication that affects liver enzymes in the last 28 days.I am not breastfeeding nor plan to while on the study and for 72 days after the last dose.I have not received any live vaccines in the last 14 days.I agree not to donate sperm during and for 132 days after my last dose of tarlatamab.I am at least 18 years old or considered an adult in my country.I am not planning to become pregnant or donate eggs during the study and for 72 days after the last dose.I am fully active or can carry out light work.My organs are working well.I haven't taken any strong medication that affects liver enzymes in the last week.I have not received any vaccines within 3 days before starting the study treatment.I don't have any health conditions that could make this study unsafe for me.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I am a woman who can have children and my pregnancy test was positive.I have had a solid organ transplant.I have not been treated with tarlatamab or taken part in any clinical trials for drugs targeting DLL3.I have not had major surgery in the last 28 days.My lung cancer changed from non-small cell to small cell type, but fits the study exceptions.My cancer returned or worsened after one platinum-based treatment.I have had more than one treatment for small cell lung cancer.I agree to use contraception or abstain from sex if my partner is pregnant while I'm on tarlatamab and for 132 days after.I haven't taken any herbal or prescription drugs that affect P-gp or BCRP in the last 7 days.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: Tarlatamab
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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