Clinical trial NCT06236438: 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)
Official title: A Randomized, Phase 2/3 Study to Evaluate the Optimal Dose, Safety, and Efficacy of Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer
Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer
NSCLC
Livmoniplimab
Budigalimab
Pembrolizumab
Chemotherapy
ABBV-181
ABBV-151
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-02-01
Enrollment: 840
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Non-Squamous Non-Small Cell Lung Cancer (NSCLC) remains a leading cause of cancer mortality worldwide, with poor survival prospects for metastatic disease. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab plus chemotherapy versus pembrolizumab plus chemotherapy in participants with untreated metastatic non-squamous non-small cell lung cancer.

Livmoniplimab is an investigational drug being developed for the treatment of NSCLC. There are 2 stages to this study. In Stage 1, there are 4 treatment arms. Participants will either receive livmoniplimab (at different doses) in combination with budigalimab (another investigational drug) + chemotherapy, budigalimab +chemotherapy, or pembrolizumab +chemotherapy. In Stage 2, there are 2 treatments arms. Participants will either receive livmoniplimab (optimized dose) in combination with budigalimab +chemotherapy or placebo in combination with pembrolizumab +chemotherapy. Chemotherapy consists of IV Infused pemetrexed + IV infused cisplatin or IV infused or injected carboplatin. Approximately 840 adult participants will be enrolled in the study across 200 sites worldwide.

Stage 1: In cohort 1, participants will receive intravenously (IV) infused livmoniplimab (dose A)+ IV infused budigalimab, + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + IV Infused pemetrexed. In cohort 2, participants will receive livmoniplimab (dose B) + budigalimab + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed. In cohort 3, participants will receive budigalimab + chemotherapy for 4 cycles followed by budigalimab + pemetrexed . In cohort 4, participants will receive IV Infused pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed. Stage 2: In arm 1, participants will receive livmoniplimab (dose optimized) + budigalimab + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed. In arm 2, participants will receive IV Infused placebo + pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed. The estimated study duration is 55 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.


Eligibility criteria: Inclusion Criteria:

* 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.
* 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.
* Life expectancy of at least 3 months and adequate organ function.

Exclusion Criteria:

- Received prior systemic therapy for the treatment of metastatic NSCLC.

Primary outcomes:
measure: Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR)
timeFrame: Up to 21 Months
measure: Stage 2: Overall Survival (OS)
timeFrame: Up to 55 Months
Secondary outcomes:
measure: Stage 1: Progression Free Survival (PFS)
timeFrame: Up to 21 Months
measure: Stage 1: Duration of Response (DOR)
timeFrame: Up to 21 Months
measure: Stage 1: OS
timeFrame: Up to 21 Months
measure: Stage 2: PFS
timeFrame: Up to 55 Months
measure: Stage 2: BOR of CR/PR
timeFrame: Up to 55 Months
measure: 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)
timeFrame: Up to 55 Months
measure: Stage 2: Change from Baseline in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
timeFrame: Up to 55 Months
measure: 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
timeFrame: Up to 55 Months
measure: Stage 2: PFS per Investigator
timeFrame: Up to 55 Months
measure: Stage 1: BOR of CR/PR per Investigator
timeFrame: Up to 21 Months
measure: Stage 2: DOR
timeFrame: Up to 55 Months
measure: Stage 2: DOR per investigator
timeFrame: Up to 55 Months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Moores Cancer Center /ID# 267782
state: California
city: Pembroke Pines
country: United States
facility: Memorial Hospital West /ID# 262221
state: Florida
city: Winter Haven
country: United States
facility: Bond Clinic /ID# 262611
state: Florida
city: Athens
country: United States
facility: University Cancer & Blood Cent /ID# 261824
state: Georgia
city: Chicago
country: United States
facility: The University of Chicago Medical Center /ID# 262259
state: Illinois
city: Westwood
country: United States
facility: University of Kansas Medical Center /ID# 263196
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington /ID# 261823
state: Kentucky
city: Grand Rapids
country: United States
facility: Cancer & Hematology Centers of Western Michigan - East /ID# 261826
state: Michigan
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 262759
state: Missouri
city: Stony Brook
country: United States
facility: Stony Brook Cancer Center /ID# 261954
state: New York
city: Greensboro
country: United States
facility: Cone Health Cancer Center /ID# 262583
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc - Blue Ash /ID# 262733
state: Ohio
city: Sayre
country: United States
facility: Guthrie Robert Packer Hospital /ID# 262758
state: Pennsylvania
city: El Paso
country: United States
facility: Renovatio clinical /ID# 262000
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital /ID# 262722
state: Texas
city: Plano
country: United States
facility: Texas Oncology - Plano East /ID# 264356
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology, P. A. /ID# 264311
state: Texas
city: The Woodlands
country: United States
facility: Renovatio Clinical /ID# 261999
state: Texas
city: Olympia
country: United States
facility: Vista Oncology - East Olympia /ID# 262303
state: Washington
city: Garran
country: Australia
facility: The Canberra Hospital /ID# 261891
state: Australian Capital Territory
city: Kingswood
country: Australia
facility: Nepean Hospital /ID# 262157
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital /ID# 261894
state: New South Wales
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires UCL Saint-Luc /ID# 261267
state: Bruxelles-Capitale
city: La Louvière
country: Belgium
facility: Hospital La Louviere Site Jolimont - Helora /ID# 261269
state: Hainaut
city: Gent
country: Belgium
facility: AZ Maria Middelares /ID# 262313
city: Liege
country: Belgium
facility: Groupe Sante CHC - Clinique du MontLegia /ID# 262338
city: Namur
country: Belgium
facility: UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 262557
city: Temuco
country: Chile
facility: Centro de Investigacion y Desarrollo Oncologico /ID# 261800
state: Araucania
city: Providencia
country: Chile
facility: Fundacion Arturo Lopez Perez /ID# 261700
state: Region Metropolitana De Santiago
city: Vitacura
country: Chile
facility: Oncored /Id# 261801
state: Region Metropolitana Santiago
city: Viña del Mar
country: Chile
facility: Sociedad Cem-Cancer Spa /Id# 262316
state: Valparaíso
city: Santiago
country: Chile
facility: Hospital Clinico Universidad De Los Andes /ID# 262665
city: Marseille
country: France
facility: APHM - Hopital Nord /ID# 261129
state: Bouches-du-Rhone
city: La Tronche
country: France
facility: CHU Grenoble - Hopital Michallon /ID# 261131
state: Isere
city: Bron
country: France
facility: Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 261644
state: Rhone
city: Creteil
country: France
facility: Centre Hosp Intercommunal de Creteil /ID# 261130
state: Val-de-Marne
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 262431
state: H_efa
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 262432
state: Yerushalayim
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East /ID# 261923
state: Chiba
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center /ID# 262703
state: Saitama
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital /ID# 261925
state: Tokyo
city: Harderwijk
country: Netherlands
facility: Ziekenhuis St. Jansdal /ID# 261193
state: Gelderland
city: Zwolle
country: Netherlands
facility: Isala /ID# 262458
state: Overijssel
city: Rio Piedras
country: Puerto Rico
facility: Pan American Center for Oncology Trials /ID# 269666
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 262723
state: A Coruna
city: L'Hospitalet de Llobregat
country: Spain
facility: Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 262118
state: Barcelona
city: Barcelona
country: Spain
facility: UOMi Cancer Center - Clinica Tres Torres /ID# 262116
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 262113
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon /ID# 262114
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 262112
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia /ID# 262115
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital /ID# 262016
city: Taipei City
country: Taiwan
facility: Mackay Memorial Hospital /ID# 262534
city: Taipei City
country: Taiwan
facility: Taipei Medical University Hospital /ID# 262020
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital /ID# 262535
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty /ID# 261786
city: Ankara
country: Turkey
facility: Ankara City Hospital /ID# 261785
city: Izmir
country: Turkey
facility: Dr. Suat Seren Gogus Has /ID# 261789
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: