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Monoclonal Antibodies

Tarlatamab Combo 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

Histologically or cytologically confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC) and no prior systemic treatment for ES-SCLC.

Age greater than or equal to 18 years old at the same time of signing the informed consent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective when used with other drugs to treat cancer.

Who is the study for?

Adults with untreated Extensive Stage Small Cell Lung Cancer (ES-SCLC) can join this trial. They should have had no prior systemic treatment for ES-SCLC, may have treated brain metastases if stable, and must be generally healthy with good organ function and performance status (ECOG 0-1). People who've had major surgery recently, other cancers within 2 years, severe immune reactions to cancer immunotherapy, active autoimmune diseases needing treatment or any form of immunosuppression are excluded.Check my eligibility

What is being tested?

The study is testing the safety of a new drug called Tarlatamab combined with Carboplatin and Etoposide chemotherapy drugs plus a PD-L1 inhibitor like Durvalumab or Atezolizumab in patients. It's an early-phase trial to see how well participants tolerate this combination therapy as a first-line treatment for ES-SCLC.See study design

What are the potential side effects?

Possible side effects include immune system reactions that could affect organs like lungs causing pneumonitis, infusion-related reactions during drug administration, potential worsening of autoimmune diseases due to immune stimulation by the drugs being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My lung cancer is in the extensive stage and I haven't had any systemic treatment for it.

Select...

I am 18 years or older and can sign the consent form.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months 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 Clinical Laboratory Tests

Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements

Number of Participants with Clinically Significant Changes in Vital Signs

+3 more

Secondary outcome measures

6-month Progression-free Survival (PFS)

Disease Control Rate(DCR)

Duration of Response (DOR)

+3 more

Trial Design

9Treatment groups

Experimental Treatment

Group I: Part 9: Dose Expansion MaintenanceExperimental Treatment2 Interventions

Expansion with Tarlatamab+Durvalumab

Group II: Part 8: Dose Expansion MaintenanceExperimental Treatment2 Interventions

Expansion of Part 5 with Durvalumab

Group III: Part 7: Dose ExpansionExperimental Treatment4 Interventions

Expansion of Part 1, 2, or 3 with Durvalumab

Group IV: Part 6: Dose Expansion MaintenanceExperimental Treatment4 Interventions

Expansion of Part 5 with Atezolizumab

Group V: Part 5: Dose Exploration MaintenanceExperimental Treatment4 Interventions

Tarlatamab+Atezolizumab

Group VI: Part 4: Dose ExpansionExperimental Treatment4 Interventions

Expansion of Part 1, Part 2, or Part 3 with Atezolizumab

Group VII: Part 3: Dose Exploration Combination Regimen 3Experimental Treatment4 Interventions

Tarlatamab+Atezolizumab+Carboplatin+Etoposide

Group VIII: Part 2: Dose Exploration Combination Regimen 2Experimental Treatment4 Interventions

Tarlatamab+Atezolizumab+Carboplatin+Etoposide

Group IX: Part 1: Dose Exploration Combination Regimen 1Experimental Treatment4 Interventions

Tarlatamab+Atezolizumab+Carboplatin+Etoposide

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6670

Durvalumab

2017

Completed Phase 2

~3870

Etoposide

2010

Completed Phase 3

~2440

Atezolizumab

2017

Completed Phase 3

~5860

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor

1,371 Previous Clinical Trials

1,377,766 Total Patients Enrolled

MDStudy DirectorAmgen

914 Previous Clinical Trials

924,239 Total Patients Enrolled

Media Library

Small Cell Lung Cancer Research Study Groups: Part 1: Dose Exploration Combination Regimen 1, Part 5: Dose Exploration Maintenance, Part 7: Dose Expansion, Part 4: Dose Expansion, Part 3: Dose Exploration Combination Regimen 3, Part 8: Dose Expansion Maintenance, Part 9: Dose Expansion Maintenance, Part 2: Dose Exploration Combination Regimen 2, Part 6: Dose Expansion Maintenance

Small Cell Lung Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT05361395 — Phase 1

Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05361395 — Phase 1

Frequently Asked Questions

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

Are numerous locations in the US administering this trial?

"At this moment, there are 7 sites searching for participants to join the study. Chapel Hill, Newark and Sioux Falls are among them as well as a few other locations. If you decide to enlist in this trial it is recommended that you pick the closest medical centre to minimize travel requirements."

Answered by AI

How many participants are being analyzed in this clinical experiment?

"The trial necessitates that 340 individuals, who satisfy the prerequisites for partaking in this research project, enroll. Potential participants can take part from multiple locations including The University of North carolina at Chapel Hill (Chapel Hill, NC) and Christiana Care Health Services (Newark, Delaware)."

Answered by AI

Are there still opportunities to take part in this research initiative?

"Affirmative, the information accessible on clinicaltrials.gov indicates that this clinical trial is actively enrolling patients. Initially published on August 24th 2022 and recently updated November 30th 2022, it seeks to recruit 340 subjects from 7 sites."

Answered by AI

To what extent does Tarlatamab pose a risk to patients?

"Our team at Power gave Tarlatamab a score of 1 because this is an initial phase trial and there is only preliminary evidence supporting its safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

2022. "First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05361395.

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