Clinical trial • Phase II/III • Oncology

LIVMONIPLIMAB for Non-small cell lung cancer (non-squamous), untreated metastatic

Phase II/III trial of LIVMONIPLIMAB for Non-small cell lung cancer (non-squamous), untreated metastatic.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer (non-squamous), untreated metastatic
Trial Stage
Phase II/III
Drug Modality
Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
13-03-2024
First CTIS Authorization Date
25-06-2024

Trial design

Randomised, pembrolizumab (keytruda 25 mg/ml concentrate for solution for infusion) iv plus platinum doublet chemotherapy (agents listed in trial: pemetrexed with carboplatin or cisplatin). specific doses and schedules are not specified in the available data.-controlled, adaptive Phase II/III trial in Spain, Belgium, Netherlands and others.

Randomised
Yes
Comparator
Pembrolizumab (KEYTRUDA 25 mg/mL concentrate for solution for infusion) IV plus platinum doublet chemotherapy (agents listed in trial: pemetrexed with carboplatin or cisplatin). Specific doses and schedules are not specified in the available data.
Adaptive
True, Stage 1 (Phase 2) is used to assess safety and activity and to select a recommended Phase 3 dose (RP3D) for livmoniplimab (dose selection/adaptive element described in the objectives).
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
103

Eligibility

Recruits 103 Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms (ICFs), including pregnancy-specific ICF parts and optional substudy ICFs, are provided in multiple country-specific versions and languages. The available data does not include explicit procedures for assent or minor consent handling..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms (ICFs), including pregnancy-specific ICF parts and optional substudy ICFs, are provided in multiple country-specific versions and languages. The available data does not include explicit procedures for assent or minor consent handling.

Inclusion criteria

  • {"criterion_text":"- Diagnosis of histologically or cytologically confirmed metastatic nonsquamous non-small cell lung cancer (NSCLC) with no known epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) mutation, or other genomic aberration for which a locally approved targeted therapy is available."}
  • {"criterion_text":"- Participant has completed palliative radiotherapy > 7 days from the first dose of study treatment."}
  • {"criterion_text":"- Must have at least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) v1.1 as determined by the local site Investigator/ radiology assessment."}
  • {"criterion_text":"- Life expectancy of at least 3 months and adequate organ function."}
  • {"criterion_text":"- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2."}
  • {"criterion_text":"- Participant has completed palliative radiotherapy > 7 days from the first dose of study treatment."}
  • {"criterion_text":"- Diagnosis of histologically or cytologically confirmed metastatic nonsquamous non-small cell lung cancer (NSCLC) with no known epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) mutation, or other genomic aberration for which a locally approved targeted therapy is available."}
  • {"criterion_text":"- Must have at least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) v1.1 as determined by the local site Investigator/ radiology assessment."}
  • {"criterion_text":"- Life expectancy of at least 3 months and adequate organ function."}
  • {"criterion_text":"- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2."}

Exclusion criteria

  • {"criterion_text":"- Received prior systemic therapy for the treatment of metastatic NSCLC."}
  • {"criterion_text":"- Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia."}
  • {"criterion_text":"- Prior allogeneic stem cell or solid organ transplantation."}
  • {"criterion_text":"- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins."}
  • {"criterion_text":"- History of positive test result(s) for hepatitis B (HBV) surface antigen or for hepatitis C (HCV) antibody."}
  • {"criterion_text":"- Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia."}
  • {"criterion_text":"- Received prior systemic therapy for the treatment of metastatic NSCLC."}
  • {"criterion_text":"- Prior allogeneic stem cell or solid organ transplantation."}
  • {"criterion_text":"- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins."}
  • {"criterion_text":"- History of positive test result(s) for hepatitis B (HBV) surface antigen or for hepatitis C (HCV) antibody."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR)","definition_or_measurement_approach":"Endpoint text provided; measurable lesion requirement per RECIST v1.1 is specified in inclusion criteria (Must have at least 1 measurable lesion per RECIST v1.1). No further endpoint definition provided in the available data."}
  • {"endpoint_text":"- Stage 2: Overall Survival (OS)","definition_or_measurement_approach":"Endpoint text provided; measurement approach (overall survival) not further defined in available data."}
  • {"endpoint_text":"- Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR)","definition_or_measurement_approach":"Duplicate entry of Stage 1 BOR (see above)."}
  • {"endpoint_text":"- Stage 2: Overall Survival (OS)","definition_or_measurement_approach":"Duplicate entry of Stage 2 OS (see above)."}

Secondary endpoints

  • {"endpoint_text":"- Stage 1: Progression Free Survival (PFS)","definition_or_measurement_approach":"Not defined in endpoint listing."}
  • {"endpoint_text":"- Stage 1: Duration of Response (DOR)","definition_or_measurement_approach":"Not defined in endpoint listing."}
  • {"endpoint_text":"- Stage 1: Overall Survival (OS)","definition_or_measurement_approach":"Not defined in endpoint listing."}
  • {"endpoint_text":"- Stage 2: Progression Free Survival (PFS)","definition_or_measurement_approach":"Not defined in endpoint listing."}
  • {"endpoint_text":"- Stage 2: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR)","definition_or_measurement_approach":"Not defined in endpoint listing."}
  • {"endpoint_text":"- Stage 2: Change from Baseline in Physical Functioning (PF) as measured by the PF domain of European Organization for Research Treatment of Cancer Quality of Life Questionnaire 17 (EORTC QLQ-F17)","definition_or_measurement_approach":"Measured by PF domain of EORTC QLQ-F17 as specified in endpoint text."}
  • {"endpoint_text":"- Stage 2: Change from Baseline in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)","definition_or_measurement_approach":"Measured by NSCLC-SAQ as specified in endpoint text."}
  • {"endpoint_text":"- Stage 2: Change from Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-F17","definition_or_measurement_approach":"Measured by Global Health Status/QoL domain of EORTC QLQ-F17 as specified in endpoint text."}
  • {"endpoint_text":"- Stage 2: Progression Free Survival per Investigator","definition_or_measurement_approach":"PFS assessed per investigator (as specified)."}
  • {"endpoint_text":"- Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR) per Investigator","definition_or_measurement_approach":"BOR per investigator (as specified)."}
  • {"endpoint_text":"- Stage 2: Duration of Response (DOR)","definition_or_measurement_approach":"Not further specified in available data."}
  • {"endpoint_text":"- Stage 2: DOR per investigator","definition_or_measurement_approach":"DOR assessed per investigator (as specified)."}
  • {"endpoint_text":"- Stage 1: Progression Free Survival (PFS)","definition_or_measurement_approach":"Duplicate entry of Stage 1 PFS (see above)."}
  • {"endpoint_text":"- Stage 1: Duration of Response (DOR)","definition_or_measurement_approach":"Duplicate entry of Stage 1 DOR (see above)."}
  • {"endpoint_text":"- Stage 1: Overall Survival (OS)","definition_or_measurement_approach":"Duplicate entry of Stage 1 OS (see above)."}
  • {"endpoint_text":"- Stage 2: Progression Free Survival (PFS)","definition_or_measurement_approach":"Duplicate entry of Stage 2 PFS (see above)."}
  • {"endpoint_text":"- Stage 2: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR)","definition_or_measurement_approach":"Duplicate entry of Stage 2 BOR (see above)."}
  • {"endpoint_text":"- Stage 2: Change from Baseline in Physical Functioning (PF) as measured by the PF domain of European Organization for Research Treatment of Cancer Quality of Life Questionnaire 17 (EORTC QLQ-F17)","definition_or_measurement_approach":"Duplicate entry (see above)."}
  • {"endpoint_text":"- Stage 2: Change from Baseline in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)","definition_or_measurement_approach":"Duplicate entry (see above)."}
  • {"endpoint_text":"- Stage 2: Change from Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-F17","definition_or_measurement_approach":"Duplicate entry (see above)."}
  • {"endpoint_text":"- Stage 2: Progression Free Survival per Investigator","definition_or_measurement_approach":"Duplicate entry (see above)."}
  • {"endpoint_text":"- Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR) per Investigator","definition_or_measurement_approach":"Duplicate entry (see above)."}
  • {"endpoint_text":"- Stage 2: Duration of Response (DOR)","definition_or_measurement_approach":"Duplicate entry (see above)."}
  • {"endpoint_text":"- Stage 2: DOR per investigator","definition_or_measurement_approach":"Duplicate entry (see above)."}

Recruitment

Planned Sample Size
103
Recruitment Window Months
87
Consent Approach
Informed consent is via country-specific subject information and informed consent forms (ICFs) provided (multiple versions listed: main ICFs, pregnancy parts, optional substudy ICFs). ICFs and recruitment guides available in multiple languages (English, Spanish, French, Dutch) per country documents. Consent is provided by the participant (adult); no explicit assent procedures for minors are described in the available data.

Methods

  • Site-based recruitment at participating trial sites using provided recruitment materials (patient brochures, posters, patient study guides) and recruitment/ICF guides.
  • Country-specific recruitment materials available (examples in document list: BE patient brochures/posters and ICF guides in Dutch/French/English; ES patient brochure and ICFs in Spanish; FR and NL recruitment/ICF procedures and patient materials).

Geography

Total Number Of Sites
21
Total Number Of Participants
57

Spain

Earliest CTIS Part Ii Submission Date
10-06-2024
Latest Decision Or Authorization Date
07-10-2025
Processing Time Days
484
Number Of Sites
7
Number Of Participants
18

Sites

Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncología
Principal Investigator Name
Jon Zugazagoitia Fraile
Principal Investigator Email
acortijo.imas12@h12o.es
Contact Person Name
Jon Zugazagoitia Fraile
Contact Person Email
acortijo.imas12@h12o.es
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncología Médica
Principal Investigator Name
Paloma Martin Martorell
Principal Investigator Email
paloma_martin@comv.es
Contact Person Name
Paloma Martin Martorell
Contact Person Email
paloma_martin@comv.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncología Médica
Principal Investigator Name
Antonio Calles Blanco
Principal Investigator Email
luis.puente@salud.madrid.org
Contact Person Name
Antonio Calles Blanco
Contact Person Email
luis.puente@salud.madrid.org
Site Name
Institut Catala D'oncologia
Department Name
Oncología Médica
Principal Investigator Name
Ernest Nadal Alforja
Principal Investigator Email
contactfortrialsICOLH@iconcologia.net
Contact Person Name
Ernest Nadal Alforja
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncología
Principal Investigator Name
Enriqueta Felip Font
Principal Investigator Email
efelip@vhio.net
Contact Person Name
Enriqueta Felip Font
Contact Person Email
efelip@vhio.net
Site Name
Micancer Center S.L.P.
Department Name
Oncología
Principal Investigator Name
Santiago Viteri Ramirez
Principal Investigator Email
ensayos@uomi.es
Contact Person Name
Santiago Viteri Ramirez
Contact Person Email
ensayos@uomi.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Oncología
Principal Investigator Name
Jorge Garcia Gonzalez
Principal Investigator Email
estiban.mendez.barrio@sergas.es
Contact Person Name
Jorge Garcia Gonzalez

Belgium

Earliest CTIS Part Ii Submission Date
31-05-2024
Latest Decision Or Authorization Date
30-09-2025
Processing Time Days
487
Number Of Sites
6
Number Of Participants
18

Sites

Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Oncology
Principal Investigator Name
Vincent Vanhaudenarde
Principal Investigator Email
vincent.vanhaudenarde@cmsenamur.be
Contact Person Name
Vincent Vanhaudenarde
Site Name
Antwerp University Hospital
Department Name
Pneumology
Principal Investigator Name
Reinier Wener
Principal Investigator Email
reinier.wener@uza.be
Contact Person Name
Reinier Wener
Contact Person Email
reinier.wener@uza.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Pneumology
Principal Investigator Name
Rachel Galot
Principal Investigator Email
rachel.galot@uclouvain.be
Contact Person Name
Rachel Galot
Contact Person Email
rachel.galot@uclouvain.be
Site Name
Az Maria Middelares Gent
Department Name
Pneumology
Principal Investigator Name
Paul Germonpré
Principal Investigator Email
paul.germonpre@azmmsj.be
Contact Person Name
Paul Germonpré
Contact Person Email
paul.germonpre@azmmsj.be
Site Name
Pole Hospitalier Jolimont
Department Name
Oncology
Principal Investigator Name
Gaetan Catala
Principal Investigator Email
gaetan.catala@helora.be
Contact Person Name
Gaetan Catala
Contact Person Email
gaetan.catala@helora.be
Site Name
CHC MontLegia
Department Name
Hemato-Oncology
Principal Investigator Name
Maryam Bourhaba
Principal Investigator Email
maryam.bourhaba@chc.be
Contact Person Name
Maryam Bourhaba
Contact Person Email
maryam.bourhaba@chc.be

Netherlands

Earliest CTIS Part Ii Submission Date
17-06-2024
Latest Decision Or Authorization Date
10-10-2025
Processing Time Days
480
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Zuyderland Medisch Centrum Stichting
Principal Investigator Name
Frank Custers
Principal Investigator Email
RenDLongziekten@zuyderland.nl
Contact Person Name
Frank Custers
Contact Person Email
RenDLongziekten@zuyderland.nl
Site Name
Isala Klinieken Stichting
Principal Investigator Name
Peter Plomp
Principal Investigator Email
p.m.j.plomp@isala.nl
Contact Person Name
Peter Plomp
Contact Person Email
p.m.j.plomp@isala.nl
Site Name
Ziekenhuis St Jansdal
Principal Investigator Name
Lisenka Boom
Principal Investigator Email
ln.boom@stjansdal.nl
Contact Person Name
Lisenka Boom
Contact Person Email
ln.boom@stjansdal.nl

France

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
21-11-2025
Processing Time Days
536
Number Of Sites
5
Number Of Participants
13

Sites

Site Name
Centre Hospitalier Regional De Marseille
Department Name
Service d'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
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Service de Pneumologie
Principal Investigator Name
Denis Moro-Sibilot
Principal Investigator Email
dmoro-sibilot@chu-grenoble.fr
Contact Person Name
Denis Moro-Sibilot
Contact Person Email
dmoro-sibilot@chu-grenoble.fr
Site Name
Centre Hospitalier Intercommunal Creteil
Department Name
Département de pneumologie
Principal Investigator Name
Christos Chouaid
Principal Investigator Email
christos.chouaid@chicreteil.fr
Contact Person Name
Christos Chouaid
Contact Person Email
christos.chouaid@chicreteil.fr
Site Name
Hospices Civils De Lyon
Department Name
Département de pneumologie
Principal Investigator Name
Michael Duruisseaux
Principal Investigator Email
michael.duruisseaux@chu-lyon.fr
Contact Person Name
Michael Duruisseaux
Site Name
Institut Curie
Department Name
Département de Pneumologie
Principal Investigator Name
Nicolas Girard
Principal Investigator Email
nicolas.girard2@curie.fr
Contact Person Name
Nicolas Girard
Contact Person Email
nicolas.girard2@curie.fr

Sponsor

Primary sponsor

Full Name
AbbVie Deutschland GmbH & Co. KG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
Iqvia Biotech LLC
Responsibilities
sponsorDuties code: 3
Name
Labcorp Central Laboratory Services SARL
Responsibilities
sponsorDuties code: 4
Name
Cytel Inc.
Responsibilities
Data Monitoring Committee - Independent Statistical Center
Name
Medidata Solutions Inc.
Responsibilities
sponsorDuties code: 7
Name
Veeva Systems Inc.
Responsibilities
sponsorDuties code: 7

Third parties

  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"Data Monitoring Committee - Independent Statistical Center (sponsorDuties code: 15)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Reimbursement and Travel Support (sponsorDuties code: 15)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Livmoniplimab
Active Substance
LIVMONIPLIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Not authorised (investigational; prodAuthStatus = 1)
Dose Levels
maxDailyDoseAmount: 1200 mg; maxTotalDoseAmount: 42 g
Maximum Dose
1200 mg
Investigational Product Name
Budigalimab
Active Substance
BUDIGALIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Not authorised (investigational; prodAuthStatus = 1)
Dose Levels
maxDailyDoseAmount: 375 mg; maxTotalDoseAmount: 13 g
Maximum Dose
375 mg
Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (marketing authorisation present; prodAuthStatus = 2)
Dose Levels
maxDailyDoseAmount: 200 mg; maxTotalDoseAmount: 7 g
Maximum Dose
200 mg
Investigational Product Name
Carboplatin 10 mg/ml Intravenous Infusion
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (prodAuthStatus = 2)
Dose Levels
maxDailyDoseAmount: 750 mg; maxTotalDoseAmount: 3 g
Maximum Dose
750 mg
Investigational Product Name
Pemetrexed medac 500 mg powder for concentrate for solution for infusion
Active Substance
PEMETREXED
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (marketing authorisation present; prodAuthStatus = 2)
Dose Levels
maxDailyDoseAmount: 500 mg/m2; maxTotalDoseAmount: 18 gm/m2
Maximum Dose
500 mg/m2
Investigational Product Name
Cisplatin 1mg/ml Injection BP
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (prodAuthStatus = 2)
Dose Levels
maxDailyDoseAmount: 75 mg/m2; maxTotalDoseAmount: 300 mg/m2
Maximum Dose
75 mg/m2
Combination Treatment
Yes

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