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

Extensive Stage Small Cell Lung Cancer Clinical Trial

Official title:

A Phase 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung (DeLLphi-303)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05361395
• Other study ID #: 20200469
• Secondary ID: 2021-005462-17
• Status: Recruiting
• Phase: Phase 1
• Start date: August 24, 2022
• Est. completion date: January 1, 2027

Study information

• Verified date: June 2024
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Extensive 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.
• Participants with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment
• Participant has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint
• NOTE: Simple urinary tract infections and uncomplicated bacterial pharyngitis are permitted if responding to an active treatment and after consultation with Medical Monitor. Participants requiring oral antibiotics who have been afebrile for >24 hours, have no leukocytosis, nor clinical signs of infection are eligible. Screening for chronic infectious conditions is not required.
• 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.

Related Conditions & MeSH terms

• Extensive Stage Small Cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
• Carboplatin
Carboplatin will be administered as an intravenous (IV) infusion.
• Etoposide
Etoposide will be administered as an intravenous (IV) infusion.
• Atezolizumab
Atezolizumab will be administered as an intravenous (IV) infusion.
• Durvalumab
Durvalumab will be administered as an intravenous (IV) infusion.

Locations

Country	Name	City	State
Australia	Chris OBrien Lifehouse	Camperdown	New South Wales
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	Algemeen Ziekenhuis Maria Middelares	Gent
Belgium	Jessa Ziekenhuis - Campus Virga Jesse	Hasselt
Belgium	AZ Delta Campus Rumbeke	Roeselare
Canada	CHU de Quebec Hopital de l Enfant Jesus	Quebec
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Denmark	Rigshospitalet	Kobenhavn
France	Centre Leon Berard	Lyon cedex 8
France	Centre Hospitalier Universitaire de Nantes, Hôpital Nord Laënnec	Saint Herblain
France	Gustave Roussy	Villejuif
Germany	Universitaetsklinikum Dresden	Dresden
Germany	Universitaetsklinikum Essen	Essen
Germany	Universitaetsklinikum Freiburg	Freiburg
Israel	Rambam Medical Center	Haifa
Israel	Hadassah Ein-Kerem Medical Center	Jerusalem
Israel	Rabin Medical Center	Petah Tikva
Israel	Sheba Medical Center	Ramat Gan
Italy	Azienda Ospedaliera Universitaria Renato Dulbecco	Catanzaro
Italy	Fondazione IRCCS San Gerardo dei Tintori	Monza (MB)
Italy	Istituto Nazionale Tumori Regina Elena	Rome
Japan	National Cancer Center Hospital East	Kashiwa-shi	Chiba
Japan	The Cancer Institute Hospital of Japanese Foundation for Cancer Research	Koto-ku	Tokyo
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Spain	Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol	Badalona	Cataluña
Spain	Hospital Universitari Vall d Hebron	Barcelona	Cataluña
Spain	Hospital Universitario 12 de Octubre	Madrid
Switzerland	Universitaetsspital Basel	Basel
Switzerland	Inselspital Bern	Bern
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Henry Ford Health System	Detroit	Michigan
United States	University of Southern California, Norris Comprehensive Cancer Center	Los Angeles	California
United States	West Virginia University Health Sciences Center	Morgantown	West Virginia
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	New York University Langone Medical Center	New York	New York
United States	Christiana Care Health Services	Newark	Delaware
United States	Swedish Cancer Institute Medical Oncology	Seattle	Washington
United States	Avera Cancer Institute	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Denmark,  France,  Germany,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Spain,  Switzerland,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with a Dose Limiting Toxicity (DLT)		24 months
Primary	Number of Participants with Treatment-emergent Adverse Events (TEAE)		24 months
Primary	Number of Participants with Treatment-related Adverse Events		24 months
Primary	Number of Participants with Clinically Significant Changes in Vital Signs		24 months
Primary	Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements		24 months
Primary	Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests		24 months
Secondary	6-month Progression-free Survival (PFS)		24 months
Secondary	Objective Response (OR)	Per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1	24 months
Secondary	Duration of Response (DOR)		24 months
Secondary	Disease Control Rate(DCR)		24 months
Secondary	Overall Survival (OS)		24 months
Secondary	Serum Concentration of Tarlatamab		24 months

External Links

•   AmgenTrials clinical trials website