Study to Evaluate Adverse Events, Optimal Dose, and Change in Disease Activity, With Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus IV Infused Pembrolizumab Plus Chemotherapy in Adult Participants With Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

2023-505773-32-00 Protocol M23-721 Phase II and Phase III (Integrated) Ongoing, recruiting

Start 25 Mar 2025 · Status Ongoing, recruiting · 4 EU/EEA countries · 21 sites · Protocol M23-721

Overview

Sponsor-declared trial summary

Phase Phase II and Phase III (Integrated)
Status Ongoing, recruiting
Participants planned 160
Countries 4
Sites 21

Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer

- Stage 1 (Phase 2): To assess the safety and activity of livmoniplimab and budigalimab in combination with platinum doublet chemotherapy and to select recommended Phase 3 dose (RP3D) for livmoniplimab. - Stage 2 (Phase 3): To evaluate the activity of the RP3D of livmoniplimab and budigalimab in combination with platin…

Key facts

Sponsor
AbbVie Deutschland GmbH & Co. KG
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
25 Mar 2025 → ongoing
Decision date (initial)
2024-06-25
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
AbbVie Inc.

External identifiers

EU CT number
2023-505773-32-00
ClinicalTrials.gov
NCT06236438

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

- Stage 1 (Phase 2): To assess the safety and activity of livmoniplimab and budigalimab in combination with platinum doublet chemotherapy and to select recommended Phase 3 dose (RP3D) for livmoniplimab.
- Stage 2 (Phase 3): To evaluate the activity of the RP3D of livmoniplimab and budigalimab in combination with platinum doublet chemotherapy versus pembrolizumab in combination with platinum doublet chemotherapy as measured by overall survival (OS).

Secondary objectives 8

  1. Stage 1 (Phase 2): - To assess the tolerability, immunogenicity, pharmacokinetics (PK), and efficacy of livmoniplimab and budigalimab in combination with platinum doublet chemotherapy to assess the contribution of livmoniplimab to the treatment combination.
  2. Stage 2 (Phase 3): - To assess the safety and tolerability of livmoniplimab and budigalimab in combination with platinum doublet chemotherapy versus pembrolizumab in combination with platinum doublet chemotherapy.
  3. Stage 2 (Phase 3):- To evaluate the efficacy of livmoniplimab and budigalimab in combination with platinum doublet chemotherapy versus pembrolizumab in combination with platinum doublet chemotherapy.
  4. Stage 2 (Phase 3): - To assess the impact of livmoniplimab and budigalimab in combination with platinum doublet chemotherapy on patient-reported outcome (PRO) assessments
  5. Stage 1 (Phase 2): - To assess the tolerability, immunogenicity, pharmacokinetics (PK), and activity of livmoniplimab and budigalimab in combination with platinum doublet chemotherapy to assess the contribution of livmoniplimab to the treatment combination.
  6. Stage 2 (Phase 3): - To assess the safety and tolerability of livmoniplimab and budigalimab in combination with platinum doublet chemotherapy versus pembrolizumab in combination with platinum doublet chemotherapy.
  7. Stage 2 (Phase 3):- To evaluate the efficacy of livmoniplimab and budigalimab in combination with platinum doublet chemotherapy versus pembrolizumab in combination with platinum doublet chemotherapy.
  8. Stage 2 (Phase 3): - To assess the impact of livmoniplimab and budigalimab in combination with platinum doublet chemotherapy on patient-reported outcome (PRO) assessments

Conditions and MedDRA coding

Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer

VersionLevelCodeTermSystem organ class
20.0 LLT 10079440 Non-squamous non-small cell lung cancer 10029104

Regulatory references

Scientific advice from competent authorities
European Medicines Agency, Abbvie Bioresearch Center Inc.
Plan to share IPD
Yes
IPD plan description
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

  1. 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.
  2. 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.
  3. Life expectancy of at least 3 months and adequate organ function.
  4. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
  5. Participant has completed palliative radiotherapy > 7 days from the first dose of study treatment.
  6. 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.
  7. 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.
  8. Life expectancy of at least 3 months and adequate organ function.
  9. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
  10. Participant has completed palliative radiotherapy > 7 days from the first dose of study treatment.

Exclusion criteria 10

  1. Received prior systemic therapy for the treatment of metastatic NSCLC.
  2. Prior allogeneic stem cell or solid organ transplantation.
  3. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
  4. History of positive test result(s) for hepatitis B (HBV) surface antigen or for hepatitis C (HCV) antibody.
  5. 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.
  6. Received prior systemic therapy for the treatment of metastatic NSCLC.
  7. Prior allogeneic stem cell or solid organ transplantation.
  8. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
  9. History of positive test result(s) for hepatitis B (HBV) surface antigen or for hepatitis C (HCV) antibody.
  10. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

  1. Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR)
  2. Stage 2: Overall Survival (OS)
  3. Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR)
  4. Stage 2: Overall Survival (OS)

Secondary endpoints 24

  1. Stage 1: Progression Free Survival (PFS)
  2. Stage 1: Duration of Response (DOR)
  3. Stage 1: Overall Survival (OS)
  4. Stage 2: Progression Free Survival (PFS)
  5. Stage 2: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR)
  6. 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)
  7. Stage 2: Change from Baseline in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
  8. 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
  9. Stage 2: Progression Free Survival per Investigator
  10. Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR) per Investigator
  11. Stage 2: Duration of Response (DOR)
  12. Stage 2: DOR per investigator
  13. Stage 1: Progression Free Survival (PFS)
  14. Stage 1: Duration of Response (DOR)
  15. Stage 1: Overall Survival (OS)
  16. Stage 2: Progression Free Survival (PFS)
  17. Stage 2: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR)
  18. 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)
  19. Stage 2: Change from Baseline in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
  20. 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
  21. Stage 2: Progression Free Survival per Investigator
  22. Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR) per Investigator
  23. Stage 2: Duration of Response (DOR)
  24. Stage 2: DOR per investigator

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Budigalimab

PRD10277708 · Product

Active substance
Budigalimab
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS
Max daily dose
375 mg milligram(s)
Max total dose
13 g gram(s)
Max treatment duration
105 Week(s)
Authorisation status
Not Authorised
MA holder
ABBVIE DEUTSCHLAND GMBH & CO. KG
Paediatric formulation
No
Orphan designation
No

Livmoniplimab

PRD10284221 · Product

Active substance
Livmoniplimab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
1200 mg milligram(s)
Max total dose
42 g gram(s)
Max treatment duration
105 Week(s)
Authorisation status
Not Authorised
MA holder
ABBVIE DEUTSCHLAND GMBH & CO. KG
Paediatric formulation
No
Orphan designation
No

Comparator 1

KEYTRUDA 25 mg/mL concentrate for solution for infusion

PRD4323105 · Product

Active substance
Pembrolizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
200 mg milligram(s)
Max total dose
7 g gram(s)
Max treatment duration
105 Week(s)
Authorisation status
Authorised
ATC code
L01FF02 — -
Marketing authorisation
EU/1/15/1024/002
MA holder
MERCK SHARP & DOHME B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Auxiliary 3

Pemetrexed medac 500 mg powder for concentrate for solution for infusion

PRD3465923 · Product

Active substance
Pemetrexed
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
500 mg/m2 milligram(s)/square meter
Max total dose
18 gm/m2 gram(s)/square meter
Max treatment duration
105 Week(s)
Authorisation status
Authorised
ATC code
L01BA04 — -
Marketing authorisation
EU/1/15/1038/002
MA holder
MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Carboplatin 10 mg/ml Intravenous Infusion

PRD1161259 · Product

Active substance
Carboplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
750 mg milligram(s)
Max total dose
3 g gram(s)
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
L01XA02 — CARBOPLATIN
Marketing authorisation
PL 04515/0050
MA holder
HOSPIRA UK LIMITED
MA country
XI
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cisplatin 1mg/ml Injection BP

PRD8127897 · Product

Active substance
Cisplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
75 mg/m2 milligram(s)/sq. meter
Max total dose
300 mg/m2 milligram(s)/sq. meter
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
L01XA01 — CISPLATIN
Marketing authorisation
PL 04416/1597
MA holder
SANDOZ LTD
MA country
XI
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

138 Total trials 54 Recruiting 80 Ended
Commercial
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Address
Knollstrasse
City
Ludwigshafen Am Rhein
Postcode
67061
Country
Germany

Scientific contact point

Organisation
AbbVie Deutschland GmbH & Co. KG
Contact name
Bernhard Dodell

Public contact point

Organisation
AbbVie Deutschland GmbH & Co. KG
Contact name
Bernhard Dodell

Third parties 6

OrganisationCity, countryDuties
Veeva Systems Inc.
ORG-100006053
 Pleasanton, United States E-data capture
Labcorp Central Laboratory Services SARL
ORG-100011524
 Meyrin, Switzerland Laboratory analysis
Cytel Inc.
ORG-100042560
 Waltham, United States Other
Medidata Solutions Inc.
ORG-100016256
 New York, United States E-data capture
Greenphire LLC
ORG-100041621
 King Of Prussia, United States Other
Iqvia Biotech LLC
ORG-100008704
 Durham, United States Interactive response technologies (IRT)

Locations

4 EU/EEA countries · 21 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ongoing, recruiting 18 6
France Ongoing, recruiting 13 5
Netherlands Ongoing, recruiting 8 3
Spain Ongoing, recruiting 18 7
Rest of world
Chile, Australia, Korea, Democratic People's Republic of, Taiwan, United States, Japan, Israel, Turkey
 — 103 —

Investigational sites

Belgium

6 sites · Ongoing, recruiting
Cliniques Universitaires Saint-Luc
Pneumology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Antwerp University Hospital
Pneumology, Drie Eikenstraat 655, 2650, Edegem
Az Maria Middelares Gent
Pneumology, Buitenring-Sint-Denijs 30, 9000, Gent
CHC MontLegia
Hemato-Oncology, Boulev. De Patience Et Beajonc 2, 4000, Liege
Pole Hospitalier Jolimont
Oncology, Rue Ferrer 159, 7100, La Louviere
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Oncology, Place Louise Godin 15, 5000, Namur

France

5 sites · Ongoing, recruiting
Centre Hospitalier Universitaire Grenoble Alpes
Service de Pneumologie, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Regional De Marseille
Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques, 265 Chemin Des Bourrely, 13015, Marseille
Institut Curie
Département de Pneumologie, 26 Rue D Ulm, 75005, Paris
Hospices Civils De Lyon
Département de pneumologie, 28 Avenue Du Doyen Jean Lepine, 69500, Bron
Centre Hospitalier Intercommunal Creteil
Département de pneumologie, 40 Avenue De Verdun, 94000, Creteil

Netherlands

3 sites · Ongoing, recruiting
Zuyderland Medisch Centrum Stichting
N/A, Henri Dunantstraat 5, 6419 PC, Heerlen
Ziekenhuis St Jansdal
N/A, Wethouder Jansenlaan 90, 3844 DG, Harderwijk
Isala Klinieken Stichting
N/A, Dokter Van Heesweg 2, 8025 AB, Zwolle

Spain

7 sites · Ongoing, recruiting
Micancer Center S.L.P.
Oncología, Calle Del Doctor Roux 76 Planta 5, 08017, Barcelona
Hospital Clinico Universitario De Valencia
Oncología Médica, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital General Universitario Gregorio Maranon
Oncología Médica, Calle Del Doctor Esquerdo 46, 28007, Madrid
Complexo Hospitalario Universitario De Santiago
Oncología, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario 12 De Octubre
Oncología, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitari Vall D Hebron
Oncología, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Institut Catala D'oncologia
Oncología Médica, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Belgium 2025-03-25 2025-04-22
France 2025-04-09 2025-04-11
Netherlands 2025-04-15 2025-10-15
Spain 2025-03-25 2025-04-09

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 58 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_ m23721-protocol-redacted 1.1.1.1
Recruitment arrangements (for publication) K1_M23-721 BE ICF Guide Dutch_Public 1
Recruitment arrangements (for publication) K1_M23-721 BE ICF Guide English_Public 1
Recruitment arrangements (for publication) K1_M23-721 BE ICF Guide French_Public 1
Recruitment arrangements (for publication) K1_M23-721 BE Patient Brochure Dutch_Public 1
Recruitment arrangements (for publication) K1_M23-721 BE Patient Brochure English_Public 1
Recruitment arrangements (for publication) K1_M23-721 BE Patient Brochure French_Public 1
Recruitment arrangements (for publication) K1_M23-721 BE Patient Poster Dutch_Public 1
Recruitment arrangements (for publication) K1_M23-721 BE Patient Poster English_Public 1
Recruitment arrangements (for publication) K1_M23-721 BE Patient Poster French_Public 1
Recruitment arrangements (for publication) K2 M23-721 ES Patient Brochure 1
Recruitment arrangements (for publication) K2 M23-721 ES Patient Poster 1
Recruitment arrangements (for publication) K2 M23-721 ES Patient Study Guide 1
Recruitment arrangements (for publication) K2 M23-721 FR Informed Consent Guide French_Public 1
Recruitment arrangements (for publication) K2 M23-721 FR Patient Brochure French_Public 1
Recruitment arrangements (for publication) K2_M23-721_NL_Patient Brochure 1
Recruitment arrangements (for publication) K2_M23-721_NL_Patient Study Guide 1
Recruitment arrangements (for publication) M23-721 BE Recruitment and ICF Procedures_Public 1
Recruitment arrangements (for publication) M23-721 ES Informed consent and recruitment procedures form 1
Recruitment arrangements (for publication) M23-721 FR Recruitment and ICF Procedures_Public 1
Recruitment arrangements (for publication) M23-721 NL Recruitment and ICF Procedures_Public 1
Subject information and informed consent form (for publication) L1 M23-721 ES ICF Main_Public 1.2
Subject information and informed consent form (for publication) L1 M23-721 ES ICF Optional Substudy_Public 1.1
Subject information and informed consent form (for publication) L1 M23-721 FR Addendum ICF_Public 1
Subject information and informed consent form (for publication) L1_M23-721 BE ICF Main Dutch_Public 4.0
Subject information and informed consent form (for publication) L1_M23-721 BE ICF Main English_Public 4.0
Subject information and informed consent form (for publication) L1_M23-721 BE ICF Main French_Public 4.0
Subject information and informed consent form (for publication) L1_M23-721 FR ICF Cont Treatment _Public 1.1
Subject information and informed consent form (for publication) L1_M23-721 FR ICF Main_Public 1.3
Subject information and informed consent form (for publication) M23-721 BE ICF Other Dutch_Public 2.0
Subject information and informed consent form (for publication) M23-721 BE ICF Other English_Public 2.0
Subject information and informed consent form (for publication) M23-721 BE ICF Other French_Public 2.0
Subject information and informed consent form (for publication) M23-721 BE ICF Preg Part Dutch_Public 2.0
Subject information and informed consent form (for publication) M23-721 BE ICF Preg Part English_Public 2.0
Subject information and informed consent form (for publication) M23-721 BE ICF Preg Part French_Public 2.0
Subject information and informed consent form (for publication) M23-721 BE Non use of pharma be template letter 1
Subject information and informed consent form (for publication) M23-721 ES ICF Disease Progression 1.0
Subject information and informed consent form (for publication) M23-721 ES ICF Pregnant Partner 1.0
Subject information and informed consent form (for publication) M23-721 FR ICF Preg Part French_Public 1.1
Subject information and informed consent form (for publication) M23-721 FR ICF Pregnant Data Release French_Public 1
Subject information and informed consent form (for publication) M23-721 NL FACT G GP5 only questionnaire Dutch_Public 1
Subject information and informed consent form (for publication) M23-721 NL ICF Main Dutch_Public 2.0
Subject information and informed consent form (for publication) M23-721 NL ICF Other Dutch_Public 1.1
Subject information and informed consent form (for publication) M23-721 NL ICF Preg Part Dutch_Public 1.1
Subject information and informed consent form (for publication) M23-721 NL PRO-CTCAE questionnaire Dutch_Public 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC-Keytruda-25mg-mL-sol for inf 1
Synopsis of the protocol (for publication) D1_ m23721-protocol synopsis-redacted 1.1.1.1
Synopsis of the protocol (for publication) D1_ m23721-protocol synopsis-redacted-DE-BE 1.1.1.1
Synopsis of the protocol (for publication) D1_ m23721-protocol synopsis-redacted-FR-BE 1.1.1.1
Synopsis of the protocol (for publication) D1_ m23721-protocol synopsis-redacted-NL 1.1.1.1
Synopsis of the protocol (for publication) D1_ m23721-protocol synopsis-redacted-NL-BE 1.1.1.1
Synopsis of the protocol (for publication) D1_m23721-protocol synopsis-lay summary-FR-FR v1
Synopsis of the protocol (for publication) D1_m23721-protocol synopsis-redacted-ES 1.1.1.1
Synopsis of the protocol (for publication) D1_m23721-protocol synopsis-redacted-FR 1.1.1.1
Synopsis of the protocol (for publication) M23-721-protocol synopsis-lay summary be-french 1
Synopsis of the protocol (for publication) M23-721-protocol synopsis-lay summary be-german 1
Synopsis of the protocol (for publication) M23-721-protocol synopsis-lay summary-dutch 1
Synopsis of the protocol (for publication) M23-721-protocol synopsis-lay summary-english 1

Application history

5 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-03-13 France Acceptable
2024-06-24
 2024-06-25
2 SUBSTANTIAL MODIFICATION SM-1 2024-07-09 Acceptable 2024-08-19
3 SUBSTANTIAL MODIFICATION SM-2 2025-01-06 France Acceptable
2025-03-19
 2025-03-20
4 SUBSTANTIAL MODIFICATION SM-4 2025-08-21 France Acceptable
2025-09-29
 2025-09-30
5 NON SUBSTANTIAL MODIFICATION NSM-3 2025-11-21 France Acceptable
2025-09-29
 2025-11-21

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