Lung Cancer Clinical Trial

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

Summary

This is a phase 1b study to assess the safety and tolerability of tarlatamab in combination with programmed death ligand (PD-L1) inhibition with and without chemotherapy.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participant has provided informed consent prior to initiation of any study specific activities/procedures.
Age greater than or equal to 18 years old at the same time of signing the informed consent.
Histologically or cytologically confirmed Extended Stage Small Cell Lung Cancer (ES-SCLC) and no prior systemic treatment for ES-SCLC.
Participants with prior treatment for limited-stage SCLC (LS-SCLC) are permitted.
Eastern Cooperative Oncology Group (ECOG) 0 to 1.
Participants with treated asymptomatic brain metastases are eligible provided they meet defined criteria.
Adequate organ function as defined in protocol.

Exclusion Criteria:

History of other malignancy within the past 2 years with exceptions.
Major surgery within 28 days of study day 1.
Untreated or symptomatic brain metastases and leptomeningeal disease.
Participants who experienced recurrent grade 2 pneumonitis or severe or life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
History of immune-related colitis.
History or evidence of interstitial lung disease or active, non-infectious pneumonitis.
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
History of solid organ transplantation.
History of hypophysitis or pituitary dysfunction.
History of solid organ transplantation or allogeneic hematopoietic stem cell transplantation.
Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. Participants with Type I diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted.

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

340

Study ID:

NCT05361395

Recruitment Status:

Recruiting

Sponsor:

Amgen

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 26 Locations for this study

See Locations Near You

University of Southern California, Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Christiana Care Health Services
Newark Delaware, 19713, United States
New York University Langone Medical Center
New York New York, 10016, United States
The University of North Carolina at Chapel Hill
Chapel Hill North Carolina, 27599, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
West Virginia University Health Sciences Center
Morgantown West Virginia, 26506, United States
Chris OBrien Lifehouse
Camperdown New South Wales, 2050, Australia
Universitair Ziekenhuis Antwerpen
Edegem , 2650, Belgium
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt , 3500, Belgium
AZ Delta Campus Rumbeke
Roeselare , 8800, Belgium
CHU de Quebec Hopital de l Enfant Jesus
Quebec , G1R 2, Canada
Centre Hospitalier Universitaire de Nantes, Hôpital Nord Laënnec
Saint Herblain , 44800, France
Gustave Roussy
Villejuif , 94805, France
Universitaetsklinikum Carl Gustav Carus
Dresden , 01307, Germany
Universitätsklinikum Essen
Essen , 45147, Germany
Universitätsklinikum Freiburg
Freiburg , 79106, Germany
National Cancer Center Hospital East
Kashiwa-shi Chiba, 277-8, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku Tokyo, 135-8, Japan
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Hospital Universitari Vall d Hebron
Barcelona Cataluña, 08035, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Universitaetsspital Basel
Basel , 4031, Switzerland
Inselspital Bern
Bern , 3010, Switzerland
National Taiwan University Hospital
Taipei , 10002, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

340

Study ID:

NCT05361395

Recruitment Status:

Recruiting

Sponsor:


Amgen

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.