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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05361395
Registration number
NCT05361395
Ethics application status
Date submitted
29/04/2022
Date registered
4/05/2022
Date last updated
13/06/2024
Titles & IDs
Public title
First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)
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Scientific 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)
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Secondary ID [1]
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2021-005462-17
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Secondary ID [2]
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20200469
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Extensive Stage Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Tarlatamab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Etoposide
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Durvalumab
Experimental: Part 1: Dose Exploration Combination Regimen 1 - Tarlatamab+Atezolizumab+Carboplatin+Etoposide
Experimental: Part 2: Dose Exploration Combination Regimen 2 - Tarlatamab+Atezolizumab+Carboplatin+Etoposide
Experimental: Part 3: Dose Exploration Combination Regimen 3 - Tarlatamab+Atezolizumab+Carboplatin+Etoposide
Experimental: Part 4: Dose Expansion - Expansion of Part 1, Part 2, or Part 3 with Atezolizumab
Experimental: Part 5: Dose Exploration Maintenance - Tarlatamab+Atezolizumab
Experimental: Part 6: Dose Expansion Maintenance - Expansion of Part 5 with Atezolizumab
Experimental: Part 7: Dose Expansion - Expansion of Part 1, 2, or 3 with Durvalumab
Experimental: Part 8: Dose Expansion Maintenance - Expansion of Part 5 with Durvalumab
Experimental: Part 9: Dose Expansion Maintenance - Expansion with Tarlatamab+Durvalumab
Treatment: Drugs: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Treatment: Drugs: Carboplatin
Carboplatin will be administered as an intravenous (IV) infusion.
Treatment: Drugs: Etoposide
Etoposide will be administered as an intravenous (IV) infusion.
Treatment: Drugs: Atezolizumab
Atezolizumab will be administered as an intravenous (IV) infusion.
Treatment: Drugs: Durvalumab
Durvalumab will be administered as an intravenous (IV) infusion.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants with a Dose Limiting Toxicity (DLT)
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Assessment method [1]
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Timepoint [1]
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24 months
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Primary outcome [2]
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Number of Participants with Treatment-emergent Adverse Events (TEAE)
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Assessment method [2]
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Timepoint [2]
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24 months
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Primary outcome [3]
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Number of Participants with Treatment-related Adverse Events
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Assessment method [3]
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Timepoint [3]
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24 months
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Primary outcome [4]
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Number of Participants with Clinically Significant Changes in Vital Signs
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Assessment method [4]
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Timepoint [4]
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24 months
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Primary outcome [5]
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Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements
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Assessment method [5]
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Timepoint [5]
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24 months
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Primary outcome [6]
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Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
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Assessment method [6]
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Timepoint [6]
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24 months
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Secondary outcome [1]
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6-month Progression-free Survival (PFS)
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Assessment method [1]
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Timepoint [1]
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24 months
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Secondary outcome [2]
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Objective Response (OR)
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Assessment method [2]
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Per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
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Timepoint [2]
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24 months
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Secondary outcome [3]
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Duration of Response (DOR)
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Assessment method [3]
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Timepoint [3]
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24 months
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Secondary outcome [4]
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Disease Control Rate(DCR)
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Assessment method [4]
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Timepoint [4]
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24 months
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Secondary outcome [5]
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Overall Survival (OS)
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Assessment method [5]
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Timepoint [5]
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24 months
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Secondary outcome [6]
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Serum Concentration of Tarlatamab
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Assessment method [6]
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Timepoint [6]
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24 months
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/08/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2027
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Actual
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Sample size
Target
340
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Chris OBrien Lifehouse - Camperdown
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment outside Australia
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United States of America
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California
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Delaware
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Michigan
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New Jersey
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New York
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North Carolina
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West Virginia
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Hasselt
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Belgium
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Roeselare
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Lyon cedex 8
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France
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Saint Herblain
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France
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Villejuif
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Germany
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Dresden
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Germany
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Essen
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Germany
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Freiburg
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petah Tikva
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Israel
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Ramat Gan
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Italy
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Catanzaro
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Italy
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Rome
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Chiba
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Japan
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Tokyo
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Groningen
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Cataluña
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Bern
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Tainan
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Taiwan
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Amgen
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Address
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT05361395
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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MD
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Address
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Amgen
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Contact person for public queries
Name
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Amgen Call Center
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Address
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Phone
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866-572-6436
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT05361395
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