Clinical trial • Phase II • Oncology|Respiratory
TARLATAMAB for Extensive-stage small cell lung cancer|Small cell lung cancer
Phase II trial of TARLATAMAB for Extensive-stage small cell lung cancer|Small cell lung cancer. open-label, none/not specified-controlled. 40 participants.
Overview
- Trial Therapeutic Area
- Oncology|Respiratory
- Trial Disease
- Extensive-stage small cell lung cancer|Small cell lung cancer
- Trial Stage
- Phase II
- Drug Modality
- Other antibody
Key dates
- Initial CTIS Submission Date
- 18-12-2025
- First CTIS Authorization Date
- 08-04-2026
Trial design
open-label, none/not specified-controlled Phase II trial in France, Greece, Italy and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 40
- Trial Duration For Participant
- 365
Eligibility
Recruits 40 Vulnerable population selected (isVulnerablePopulationSelected = true). Written informed consent is required: "Written Informed Consent signed before any trial-related intervention". Subject information and informed consent forms (L1_SIS and ICF Master) are provided in multiple languages (documents present for FR, EL, IT, ES). No specific assent procedures for minors are provided (study includes adults age ≥18)..
- Pregnancy Exclusion
- Negative pregnancy test for female participants of childbearing potential
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). Written informed consent is required: "Written Informed Consent signed before any trial-related intervention". Subject information and informed consent forms (L1_SIS and ICF Master) are provided in multiple languages (documents present for FR, EL, IT, ES). No specific assent procedures for minors are provided (study includes adults age ≥18).
Inclusion criteria
- {"criterion_text":"- Histologically or cytologically confirmed ES-SCLC\n- Previous treatment with only one line of platinum-etoposide doublet chemotherapy with immune-checkpoint inhibition for SCLC\n- Progressive disease on or after the first-line treatment for SCLC\n- ECOG Performance Status 2\n- Age ≥18 years\n- Adequate organ function\n- Negative pregnancy test for female participants of childbearing potential\n- Written Informed Consent signed before any trial-related intervention"}
Exclusion criteria
- {"criterion_text":"- Symptomatic CNS metastases\n- Diagnosis or evidence of leptomeningeal disease or spinal cord compression\n- Prior history of immune-related recurrent pneumonitis (grade ≥2)) or severe immune-mediated adverse events\n- Evidence of interstitial lung disease or active, non-infectious pneumonitis\n- Active autoimmune disease\n- History of solid organ transplantation\n- Presence or history of an uncontrolled viral infection\n- History of other malignancy within the past 2 years"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Overall survival rate at 12 months (12-month OS)","definition_or_measurement_approach":"Assess the clinical efficacy of tarlatamab in terms of 12-month overall survival (OS) rate (i.e. overall survival rate at 12 months)."}
Secondary endpoints
- {"endpoint_text":"- Objective response rate (ORR) according to RECIST v1.1","definition_or_measurement_approach":"Objective response rate measured according to RECIST v1.1 criteria."}
- {"endpoint_text":"- Duration of response (DoR)","definition_or_measurement_approach":"Duration of response as defined in protocol (DoR)."}
- {"endpoint_text":"- Disease control rate (DCR)","definition_or_measurement_approach":"Disease control rate as defined in the protocol (DCR)."}
- {"endpoint_text":"- Progression-free survival (PFS) according to RECIST v1.1","definition_or_measurement_approach":"Progression-free survival measured according to RECIST v1.1 criteria."}
- {"endpoint_text":"- Incidence, nature, and severity of adverse events according to CTCAE v5, except for CRS and ICANS, that are graded according to the ASTCT criteria and TLS that are graded according to the Cairo-Bishop classification","definition_or_measurement_approach":"Safety assessed by incidence, nature and severity of adverse events per CTCAE v5; CRS and ICANS graded per ASTCT criteria; TLS graded per Cairo-Bishop classification."}
Recruitment
- Registry Or Advocacy Recruitment
- True, Fundacion GECP
- Planned Sample Size
- 40
- Recruitment Window Months
- 41
- Consent Approach
- Written informed consent required: "Written Informed Consent signed before any trial-related intervention". Consent materials (Subject Information Sheet and Informed Consent Form) are provided (documents L1_SIS and ICF Master) in multiple languages including French, Greek (EL), Italian and Spanish. Participants are adults (age ≥18) who provide consent themselves.
Geography
- Total Number Of Sites
- 11
- Total Number Of Participants
- 40
France
- Earliest CTIS Part Ii Submission Date
- 09-03-2026
- Latest Decision Or Authorization Date
- 13-04-2026
- Processing Time Days
- 35
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Centre Leon Berard
- Department Name
- Pulmology
- Principal Investigator Name
- Maurice Perol
- Principal Investigator Email
- maurice.perol@lyon.unicancer.fr
- Contact Person Name
- Maurice Perol
- Contact Person Email
- maurice.perol@lyon.unicancer.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Service Oncologie Multidisciplinaire et Innovations Thérapeutiques
- Principal Investigator Name
- Laurent Greillier
- Principal Investigator Email
- laurent.greillier@ap-hm.fr
- Contact Person Name
- Laurent Greillier
- Contact Person Email
- laurent.greillier@ap-hm.fr
- Site Name
- Institut Bergonie
- Department Name
- Oncology
- Principal Investigator Name
- Sophie Cousin
- Principal Investigator Email
- s.cousin@bordeaux.unicancer.fr
- Contact Person Name
- Sophie Cousin
- Contact Person Email
- s.cousin@bordeaux.unicancer.fr
Greece
- Earliest CTIS Part Ii Submission Date
- 17-02-2026
- Latest Decision Or Authorization Date
- 08-04-2026
- Processing Time Days
- 50
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Henry Dunant Hospital Center
- Department Name
- 4th Oncology Department and Clinical Trials Unit
- Principal Investigator Name
- Ioannis Mountzios
- Principal Investigator Email
- gmountzios@gmail.com
- Contact Person Name
- Ioannis Mountzios
- Contact Person Email
- gmountzios@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 10-04-2026
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 10
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Azienda Ospedaliera Di Perugia
- Department Name
- Medical oncology
- Principal Investigator Name
- Giulio Metro
- Principal Investigator Email
- giulio.metro@ospedale.perugia.it
- Contact Person Name
- Giulio Metro
- Contact Person Email
- giulio.metro@ospedale.perugia.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Thoracic oncology
- Principal Investigator Name
- Angelo Delmonte
- Principal Investigator Email
- angelo.delmonte@irst.emr.it
- Contact Person Name
- Angelo Delmonte
- Contact Person Email
- angelo.delmonte@irst.emr.it
Spain
- Earliest CTIS Part Ii Submission Date
- 10-03-2026
- Latest Decision Or Authorization Date
- 15-04-2026
- Processing Time Days
- 36
- Number Of Sites
- 5
- Number Of Participants
- 10
Sites
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Medical Oncology
- Principal Investigator Name
- Mariano Provencio Pulla
- Principal Investigator Email
- mprovencio.ensayosclinicos@gmail.com
- Contact Person Name
- Mariano Provencio Pulla
- Contact Person Email
- mprovencio.ensayosclinicos@gmail.com
- Site Name
- Hospital General Universitario Dr. Balmis
- Department Name
- Medical Oncology
- Principal Investigator Name
- Juan Luis Marti Ciriquian
- Principal Investigator Email
- juanluismarti@hotmail.com
- Contact Person Name
- Juan Luis Marti Ciriquian
- Contact Person Email
- juanluismarti@hotmail.com
- Site Name
- ICO L'HOSPITALET HOSPITAL DURAN I REYNALS
- Department Name
- Medical Oncology
- Principal Investigator Name
- Miguel Ángel Mosteiro Lamas
- Principal Investigator Email
- miguelamosteiro@iconcologia.net
- Contact Person Name
- Miguel Ángel Mosteiro Lamas
- Contact Person Email
- miguelamosteiro@iconcologia.net
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Medical Oncology
- Principal Investigator Name
- Andrés Barba
- Principal Investigator Email
- abarba@santpau.cat
- Contact Person Name
- Andrés Barba
- Contact Person Email
- abarba@santpau.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical Oncology
- Principal Investigator Name
- Pedro Filipe Simoes
- Principal Investigator Email
- pedrorocha@vhio.net
- Contact Person Name
- Pedro Filipe Simoes
- Contact Person Email
- pedrorocha@vhio.net
Sponsor
Primary sponsor
- Full Name
- ETOP IBCSG Partners Foundation
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Switzerland
Third parties
- {"country":"Switzerland","full_name":"Centre Hospitalier Universitaire Vaudois","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Greece","full_name":"Frontier Science Foundation-Hellas","duties_or_roles":"sponsorDuties codes: [10, 11]","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"Acceler8 Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [1, 12, 5]","organisation_type":"Health care"}
- {"country":"Spain","full_name":"Fundacion GECP","duties_or_roles":"sponsorDuties codes: [1, 12, 2]","organisation_type":"Patient organisation/association"}
Investigational products
- Investigational Product Name
- Tarlatamab
- Active Substance
- TARLATAMAB
- Modality
- Other antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- Intravenous infusion
- Authorisation Status
- Authorised
- Starting Dose
- 1 mg (C1D1)
- Dose Levels
- 1 mg (C1D1); 10 mg (C1D8, C1D15), then 10 mg Q2W
- Frequency
- 1 mg on C1D1; 10 mg on C1D8 and C1D15; then 10 mg every two weeks (Q2W)
- Maximum Dose
- 10 mg
- Investigational Product Name
- Tarlatamab
- Active Substance
- TARLATAMAB
- Modality
- Other antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- Intravenous infusion
- Authorisation Status
- Authorised
- Starting Dose
- 1 mg (C1D1)
- Dose Levels
- 1 mg (C1D1); 10 mg (C1D8, C1D15), then 10 mg Q2W
- Frequency
- 1 mg on C1D1; 10 mg on C1D8 and C1D15; then 10 mg every two weeks (Q2W)
- Maximum Dose
- 10 mg
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