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Tarlatamab + AMG 404 for Small Cell Lung Cancer
Phase 1
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age greater than or equal to 18 years old at the same time of signing the informed consent
Participants with histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) who progressed or recurred following at least 1 platinum-based regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is testing a new cancer drug combo to see if it's safe and works well.
Who is the study for?
Adults over 18 with Small Cell Lung Cancer (SCLC) that's worsened after platinum-based therapy can join. They must be fairly active (ECOG 0-1), have treated brain metastases meeting certain conditions, proper organ function, and no recent other cancers or major surgeries. Immune system issues, untreated brain problems, or prior similar treatments disqualify them.Check my eligibility
What is being tested?
The trial is testing the safety and best dose of tarlatamab combined with AMG 404 in treating SCLC. It aims to find out how well patients tolerate this combination and establish a recommended dosage for further studies.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system affecting various organs, potential lung issues like pneumonitis, infusion-related reactions which could range from mild discomfort to severe responses requiring treatment discontinuation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years or older and can sign the consent form.
Select...
My small cell lung cancer returned after platinum-based treatment.
Select...
I can carry out all my daily activities without help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with a Clinically Significant Change from Baseline in Clinical Laboratory Tests
Number of Participants with a Clinically Significant Change from Baseline in Electrocardiogram (ECG) Measurements
Number of Participants with a Clinically Significant Change from Baseline in Vital Signs
+3 moreSecondary outcome measures
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Tarlatamab in Combination with AMG 404
Disease Control Rate (DCR)
Duration of Response (DOR)
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Phase 2: Dose ExpansionExperimental Treatment2 Interventions
Participants will receive the RP2D of tarlatamab in combination with AMG 404 identified in Phase 1 (dose exploration) of the study.
Group II: Phase 1: Dose ExplorationExperimental Treatment2 Interventions
The recommended phase 2 target dose (RP2D) of tarlatamab in combination with AMG 404 will be estimated using a modified toxicity probability interval (mTPI-2) design. A combination RP2D may be identified based on emerging safety, efficacy, and pharmacodynamic data prior to reaching an maximum tolerated dose (MTD).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AMG 404
2020
Completed Phase 1
~230
Find a Location
Who is running the clinical trial?
AmgenLead Sponsor
1,370 Previous Clinical Trials
1,377,665 Total Patients Enrolled
MDStudy DirectorAmgen
913 Previous Clinical Trials
924,108 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had an organ transplant.I finished any palliative radiotherapy at least a week before starting tarlatamab.I had severe side effects from immune therapy that stopped my treatment.I haven't needed systemic treatment for an autoimmune disease in the last 2 years, except for hormone replacement.I have had treatment for brain metastases and meet specific criteria.I am 18 years or older and can sign the consent form.I have had issues with my pituitary gland.My small cell lung cancer returned after platinum-based treatment.I have not received tarlatamab or DLL3 x CD3 bispecific therapy before.I have not taken steroids or immunosuppressants in the last 7 days.I have not had any other cancer in the last 2 years.I finished chemotherapy over 2 weeks ago and have no major side effects.I have lung scarring or inflammation not caused by an infection.I can carry out all my daily activities without help.I had an immune-related colitis but have recovered and it's been 3 months since.I have not had major surgery within the last 4 weeks.I have brain metastases or leptomeningeal disease that hasn't been treated or is causing symptoms.It's been over 28 days since my last cancer treatment before starting tarlatamab.My organs are functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1: Dose Exploration
- Group 2: Phase 2: Dose Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum capacity for participants in this clinical research project?
"This clinical trial calls for the recruitment of 50 suitable participants. Interested individuals can access this study at either Tennessee Oncology, PLLC in Nashville or University of Kentucky located in Lexington."
Answered by AI
Has AMG 757 been granted the endorsement of the FDA?
"Limited clinical data exists that supports the safety and efficacy of AMG 757, so it is rated a 1 on our scale."
Answered by AI
Is enrollment for this experiment still open to new participants?
"The trial is currently enrolling participants, per the latest update on clinicaltrials.gov which dates back to September 28th 2022; initially posted a full year prior."
Answered by AI
How many sites are hosting this clinical trial?
"Seven sites are currently recruiting participants for this trial, including Tennessee Oncology in Nashville, University of Kentucky at Lexington, and Northwestern University's Robert H Lurie Comprehensive Cancer Centre. Additionally, four other locations exist throughout the country."
Answered by AI
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