Tarlatamab as first-line treatment in combination with carboplatin, etoposide, and PD-L1 inhibitor in patients with extensive-stage small cell lung cancer (ES-SCLC)
Summary description of the study
This is a phase 1b study to evaluate the safety, tolerability, pharmacokinetics (what the human body does with the investigational drug), pharmacodynamics (what the investigational drug does to the human body), and preliminary efficacy of first-line treatment with Tarlatamab (investigational drug in the study) in combination with standard chemoimmunotherapy in patients with extensive-stage small cell lung cancer (ES-SCLC). This study is an open-label study, meaning that both the participants and the study physician know what treatment they are receiving and at what dosage. The study will last approximately 12 months for each participant. However, the duration of treatment will depend on how your disease responds to Tarlatamab and how your body tolerates it. Your participation duration may be shorter or longer than this timeframe.
(BASEC)
Intervention under investigation
This project aims to provide us the opportunity to evaluate the tolerability (good or bad effects) and safety of Tarlatamab in combination with atezolizumab and chemotherapy for the treatment of extensive-stage small cell lung cancer. The investigational drug contains the active ingredient Tarlatamab. Tarlatamab is a type of protein that binds to target cells and stimulates the body's immune system to kill cancer cells.
This study will also assess which doses of Tarlatamab are safe for humans and how it affects extensive-stage small cell lung cancer.
(BASEC)
Disease under investigation
Extensive-stage small cell lung cancer
(BASEC)
Participants will be included in the study if they meet the following criteria: - Age ≥ 18 years - Participants with histologically or cytologically confirmed ES-SCLC and no prior systemic treatment for ES-SCLC except for the first-line therapy described below. Participants with prior treatment for advanced-stage SCLC are allowed o Parts 1 to 4: The participant must have completed one cycle of platinum-based chemotherapy, etoposide, and PD-L1 inhibitor. Participants who had no access to a PD-L1 inhibitor are allowed o Parts 5 and 6: Participants must have completed 4 cycles of first-line chemotherapy with platinum, etoposide, and PD-L1 inhibitor and must not have experienced disease progression. If there is no access to a PD-L1 inhibitor for first-line treatment, patients who have received 4 to 6 cycles of platinum-based chemotherapy plus etoposide are eligible - Measurable disease according to the modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (only for Parts 1 to 4). - Individuals with treated asymptomatic brain metastases are eligible, provided they meet the following criteria o Only supratentorial and cerebellar metastases allowed o Stereotactic radiosurgery must be completed at least 7 days prior to the first planned dose of study treatment o No need for corticosteroids and no or stable doses of antiepileptics o No signs of radiological progression of the central nervous system (CNS) after definitive therapy at the time of study screening o New or asymptomatic CNS metastases discovered during screening examinations must be irradiated or surgically treated to address CNS metastases. A repeat imaging study is not required if all the above criteria are met. (BASEC)
Exclusion criteria
Participants will be excluded from the study if any of the following criteria are met: - Untreated or symptomatic brain metastases and/or leptomeningeal disease - History or signs of interstitial lung disease or active non-infectious pneumonitis - Diagnosis of immunodeficiency or receipt of systemic steroid therapy or another form of immunosuppressive therapy within 7 days prior to the first dose of study treatment (BASEC)
Trial sites
Basel, Bern
(BASEC)
Sponsor
Amgen Switzerland AG
(BASEC)
Contact
Contact Person Switzerland
Dr. med. Andreas Schmitt
+41 61 265 50 74
andreasmichael.schmitt@clutterusb.chUniversitätsspital Basel Petersgraben 4 CH-4031 Basel
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
10.05.2022
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
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 Cancer (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
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Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
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