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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Livmoniplimab, Budigalimab, Pembrolizumab, Pemetrexed.
- Who it may be relevant to
- Registry conditions: Non-Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Belgium, Chile, France +7
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
Overview
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.
Interventions
- Drug Livmoniplimab
Intravenously (IV) Infusion - Drug Budigalimab
IV Infusion - Drug Pembrolizumab
IV Infusion - Drug Pemetrexed
IV Infusion - Drug Cisplatin
IV Infusion - Drug Carboplatin
IV Injection - Drug Carboplatin
IV Infusion
Primary outcome measures
- Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR) [Time frame: Up to 21 Months]
- Stage 2: Overall Survival (OS) [Time frame: Up to 55 Months]
Secondary outcome measures (12)
- Stage 1: Progression Free Survival (PFS) [Time frame: Up to 21 Months]
- Stage 1: Duration of Response (DOR) [Time frame: Up to 21 Months]
- Stage 1: OS [Time frame: Up to 21 Months]
- Stage 2: PFS [Time frame: Up to 55 Months]
- Stage 2: BOR of CR/PR [Time frame: Up to 55 Months]
- 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) [Time frame: Up to 55 Months]
- Stage 2: Change from Baseline in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) [Time frame: Up to 55 Months]
- 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 [Time frame: Up to 55 Months]
- Stage 2: PFS per Investigator [Time frame: Up to 55 Months]
- Stage 1: BOR of CR/PR per Investigator [Time frame: Up to 21 Months]
- Stage 2: DOR [Time frame: Up to 55 Months]
- Stage 2: DOR per investigator [Time frame: Up to 55 Months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 19 centers
- Moores Cancer Center /ID# 267782 — La Jolla
- Memorial Hospital West /ID# 262221 — Pembroke Pines
- Bond Clinic /ID# 262611 — Winter Haven
- University Cancer & Blood Cent /ID# 261824 — Athens
- The University of Chicago Medical Center /ID# 262259 — Chicago
- University of Kansas Medical Center /ID# 263196 — Westwood
- Baptist Health Lexington /ID# 261823 — Lexington
- Cancer & Hematology Centers of Western Michigan - East /ID# 261826 — Grand Rapids
- … and 11 more centers
Spain · 7 centers
- Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 262723 — Santiago de Compostela
- Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 262118 — L'Hospitalet de Llobregat
- UOMi Cancer Center - Clinica Tres Torres /ID# 262116 — Barcelona
- Hospital Universitario Vall de Hebron /ID# 262113 — Barcelona
- Hospital General Universitario Gregorio Maranon /ID# 262114 — Madrid
- Hospital Universitario 12 de Octubre /ID# 262112 — Madrid
- Hospital Clinico Universitario de Valencia /ID# 262115 — Valencia
Belgium · 6 centers
- Universitair Ziekenhuis Antwerpen /ID# 261270 — Edegem
- Cliniques Universitaires UCL Saint-Luc /ID# 261267 — Brussels
- Hospital La Louviere Site Jolimont - Helora /ID# 261269 — La Louvière
- Groupe Sante CHC - Clinique du MontLegia /ID# 262338 — Liège
- AZ Maria Middelares /ID# 262313 — Ghent
- UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 262557 — Namur
Chile · 5 centers
- Centro de Investigacion y Desarrollo Oncologico /ID# 261800 — Temuco
- Oncored /Id# 261801 — Vitacura
- Fundacion Arturo Lopez Perez /ID# 261700 — Providencia
- Sociedad Cem-Cancer Spa /Id# 262316 — Viña del Mar
- Hospital Clinico Universidad De Los Andes /ID# 262665 — Santiago
France · 5 centers
- APHM - Hopital Nord /ID# 261129 — Marseille
- CHU Grenoble - Hopital Michallon /ID# 261131 — La Tronche
- Institut Curie /ID# 261127 — Paris
- Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 261644 — Bron
- Centre Hosp Intercommunal de Creteil /ID# 261130 — Créteil
Taiwan · 4 centers
- National Cheng Kung University Hospital /ID# 262016 — Tainan
- Mackay Memorial Hospital /ID# 262534 — Taipei
- Taipei Medical University Hospital /ID# 262020 — Taipei
- Linkou Chang Gung Memorial Hospital /ID# 262535 — Taoyuan City
Australia · 3 centers
- Canberra Hospital /ID# 261891 — Garran
- Nepean Hospital /ID# 262157 — Kingswood
- Westmead Hospital /ID# 261894 — Westmead
Japan · 3 centers
- National Cancer Center Hospital East /ID# 261923 — Kashiwa-shi
- Saitama Prefectural Cancer Center /ID# 262703 — Kitaadachi-gun
- National Cancer Center Hospital /ID# 261925 — Chuo-ku
Netherlands · 3 centers
- Ziekenhuis St. Jansdal /ID# 261193 — Harderwijk
- Zuyderland Medisch Centrum /ID# 261190 — Heerlen
- Isala /ID# 262458 — Zwolle
Turkey (Türkiye) · 3 centers
- Gazi University Medical Faculty /ID# 261786 — Ankara
- Ankara City Hospital /ID# 261785 — Ankara
- Dr. Suat Seren Gogus Has /ID# 261789 — Izmir
Israel · 2 centers
- Shaare Zedek Medical Center /ID# 262432 — Jerusalem
- Rambam Health Care Campus /ID# 262431 — Haifa
Puerto Rico · 1 center
- Pan American Center for Oncology Trials /ID# 269666 — Rio Piedras
Identifiers
NCT: NCT06236438 · M23-721 · 2023-505773-32-00