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Tarlatamab for Small Cell Lung Cancer (DeLLphi-304 Trial)
DeLLphi-304 Trial Summary
This trial will compare a new drug to current treatments to see if it helps people live longer.
DeLLphi-304 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.DeLLphi-304 Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Standard of Care
- Group 2: Tarlatamab
- 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.
- 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.
Frequently Asked Questions
Has the FDA approved Tarlatamab for clinical use?
"Our assessment of the safety profile for Tarlatamab was a 3 due to prior data collected during Phase 3 clinical trials, which supports its efficacy and safety."
Are there available slots to join this trial?
"Yes, this trial is actively recruiting according to the information provided on clinicaltrials.gov. The original posting was made in May 31st of 2023 and it has since been updated in June 6th of the same year."
How many healthcare facilities are administering this experiment?
"Right now, this trial is being administered at 9 medical facilities. Participants may choose the location that best suits their needs; these sites are located in Cheongju, Chungbuk, Incheon and Jinju-si among other cities."
What is the maximum amount of participants allowed in this clinical research?
"Affirmative. The clinicaltrials.gov database suggests that this trial is actively recruiting, having first been posted on May 31st 2023 and last updated June 6th 2023. There are a total of 700 individuals sought from 9 different medical sites for the study."
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