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CAR T-cell Therapy

Tarlatamab for Small Cell Lung Cancer

Phase 1
Recruiting
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 time of signing the informed consent
Participants with treated brain metastases are eligible provided they meet defined criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing a new drug to treat small cell lung cancer to see if it is safe and effective.

Who is the study for?
Adults over 18 with small cell lung cancer that's come back or didn't respond after chemo can join. They must have stable brain metastases, good organ function, and an ECOG status of 0-2. No recent immunosuppressants, untreated brain issues, severe immune reactions to cancer drugs, active infections or major surgery within the last month.Check my eligibility
What is being tested?
The trial is testing Tarlatamab's safety and how the body processes it in adults with SCLC. It includes strategies to manage side effects (CRS Mitigation) and compares Tarlatamab with Pembrolizumab—a known treatment.See study design
What are the potential side effects?
Possible side effects include immune system reactions like inflammation in various organs, infusion-related symptoms such as fever or chills, fatigue, potential worsening of existing conditions like pneumonitis or autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have had treatment for brain metastases and meet specific criteria.
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My organs are functioning well.
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My small cell lung cancer has returned or worsened after platinum-based treatment.
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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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
Number of participants with clinically significant changes in vital signs for all indications
Number of participants with dose limiting toxicities (DLT) for all indications
Number of participants with significant changes in clinical laboratory tests for all indications
+4 more
Secondary outcome measures
9-month Overall Survival (OS) for all indications
9-month Progression-Free Survival (PFS) for all indications
Accumulation following multiple dosing for all indications
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Experimental Treatment
Group I: Part GExperimental Treatment1 Intervention
Tarlatamab additional dosing schedule Optional wearable digital device substudy (US sites only)
Group II: Part FExperimental Treatment1 Intervention
Tarlatamab administered in outpatient infusion centers with 8-hour monitoring Optional wearable digital device substudy (US sites only)
Group III: Part EExperimental Treatment1 Intervention
Tarlatamab administration with 24-hour monitoring
Group IV: Part DExperimental Treatment2 Interventions
Tarlatamab with additional CRS mitigation strategies
Group V: Part CExperimental Treatment2 Interventions
Tarlatamab with Pembrolizumab
Group VI: Part AExperimental Treatment1 Intervention
Tarlatamab monotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2070

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,351 Previous Clinical Trials
1,375,730 Total Patients Enrolled
MDStudy DirectorAmgen
893 Previous Clinical Trials
913,362 Total Patients Enrolled

Media Library

AMG 757 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03319940 — Phase 1
Small Cell Lung Cancer Research Study Groups: Part A, Part C, Part D, Part E, Part F, Part G
Small Cell Lung Cancer Clinical Trial 2023: AMG 757 Highlights & Side Effects. Trial Name: NCT03319940 — Phase 1
AMG 757 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03319940 — Phase 1

Frequently Asked Questions

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

Is participation in this medical experiment open at present?

"Affirmative. Clinicaltrials.gov conveys that this study is presently recruiting for 382 participants from 12 different medical sites, and was first announced on December 26th 2017 with its last update taking place on October 19th 2022."

Answered by AI

How many healthcare centers are overseeing this clinical trial?

"This medical research is being conducted in 12 clinical settings, including the Ohio State University Wexner Medical Center, Washington University of Saint Louis and John Hopkins Sidney Kimmel Comprehensive Cancer Centre. The other locations are likewise specified on the study site."

Answered by AI

What is the scope of recruitment for this investigation?

"Yes, as confirmed by the clinicaltrials.gov registry, this clinical research study is open to enrollment at 12 different sites and seeking 382 participants. The trial was initially posted on December 26th 2017 with its most recent update being October 19th 2022."

Answered by AI

To what degree have CRS Mitigation Strategies been explored in prior research?

"Presently, 961 medical trials related to CRS Mitigation Strategies are in progress. Of those studies, 122 have progressed to Phase 3 of the trial process. While most of these trials are based out of Houston, TX, a total of 35 731 locations worldwide are involved with researching this potential treatment option."

Answered by AI

Has the FDA approved CRS Mitigation Strategies for use in medical treatments?

"Since this is a Phase 1 trial, with limited data affirming its safety and efficacy, CRS Mitigation Strategies was given a rating of 1."

Answered by AI

What sorts of medical conditions are CRS Mitigation Strategies usually employed to address?

"CRS Mitigation Strategies are routinely deployed to treat malignant neoplasms, in addition to unresectable melanoma, diseases with high microsatellite instability, and chemotherapy-resistant progression."

Answered by AI
~39 spots leftby Oct 2024