Trial Title:
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)
NCT ID:
NCT06236438
Condition:
Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carboplatin
Pembrolizumab
Pemetrexed
Conditions: Keywords:
Non-Small Cell Lung Cancer
Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer
NSCLC
Livmoniplimab
Budigalimab
Pembrolizumab
Chemotherapy
ABBV-181
ABBV-151
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Livmoniplimab
Description:
Intravenously (IV) Infusion
Arm group label:
Stage 1 (Cohort 1): Livmoniplimab Dose A
Arm group label:
Stage 1 (Cohort 2): Livmoniplimab Dose B
Arm group label:
Stage 2 (Arm 1): Livmoniplimab (Dose Optimized)
Other name:
ABBV-151
Intervention type:
Drug
Intervention name:
Budigalimab
Description:
IV Infusion
Arm group label:
Stage 1 (Cohort 1): Livmoniplimab Dose A
Arm group label:
Stage 1 (Cohort 2): Livmoniplimab Dose B
Arm group label:
Stage 1 (Cohort 3): Budigalimab
Arm group label:
Stage 2 (Arm 1): Livmoniplimab (Dose Optimized)
Other name:
ABBV-181
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
IV Infusion
Arm group label:
Stage 1 (Cohort 4): Pembrolizumab
Arm group label:
Stage 2 (Arm 2): Placebo
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
IV Infusion
Arm group label:
Stage 1 (Cohort 1): Livmoniplimab Dose A
Arm group label:
Stage 1 (Cohort 2): Livmoniplimab Dose B
Arm group label:
Stage 1 (Cohort 3): Budigalimab
Arm group label:
Stage 1 (Cohort 4): Pembrolizumab
Arm group label:
Stage 2 (Arm 1): Livmoniplimab (Dose Optimized)
Arm group label:
Stage 2 (Arm 2): Placebo
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
IV Infusion
Arm group label:
Stage 1 (Cohort 1): Livmoniplimab Dose A
Arm group label:
Stage 1 (Cohort 2): Livmoniplimab Dose B
Arm group label:
Stage 1 (Cohort 3): Budigalimab
Arm group label:
Stage 1 (Cohort 4): Pembrolizumab
Arm group label:
Stage 2 (Arm 1): Livmoniplimab (Dose Optimized)
Arm group label:
Stage 2 (Arm 2): Placebo
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
IV Injection
Arm group label:
Stage 1 (Cohort 1): Livmoniplimab Dose A
Arm group label:
Stage 1 (Cohort 2): Livmoniplimab Dose B
Arm group label:
Stage 1 (Cohort 3): Budigalimab
Arm group label:
Stage 1 (Cohort 4): Pembrolizumab
Arm group label:
Stage 2 (Arm 1): Livmoniplimab (Dose Optimized)
Arm group label:
Stage 2 (Arm 2): Placebo
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
IV Infusion
Arm group label:
Stage 1 (Cohort 1): Livmoniplimab Dose A
Arm group label:
Stage 1 (Cohort 2): Livmoniplimab Dose B
Arm group label:
Stage 1 (Cohort 3): Budigalimab
Arm group label:
Stage 1 (Cohort 4): Pembrolizumab
Arm group label:
Stage 2 (Arm 1): Livmoniplimab (Dose Optimized)
Arm group label:
Stage 2 (Arm 2): Placebo
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Hospital West /ID# 262221
Address:
City:
Pembroke Pines
Zip:
33028
Country:
United States
Status:
Recruiting
Facility:
Name:
Bond Clinic /ID# 262611
Address:
City:
Winter Haven
Zip:
33880
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Coordinator
Phone:
863-293-1191 ex 3790
Facility:
Name:
University Cancer & Blood Cent /ID# 261824
Address:
City:
Athens
Zip:
30607
Country:
United States
Status:
Recruiting
Facility:
Name:
Baptist Health Lexington /ID# 261823
Address:
City:
Lexington
Zip:
40503
Country:
United States
Status:
Recruiting
Facility:
Name:
Cancer & Hematology Centers of Western Michigan - East /ID# 261826
Address:
City:
Grand Rapids
Zip:
49546-7062
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Coordinator
Phone:
616-975-3065
Facility:
Name:
Washington University-School of Medicine /ID# 262759
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Oncology Hematology Care, Inc - Blue Ash /ID# 262733
Address:
City:
Cincinnati
Zip:
45252
Country:
United States
Status:
Recruiting
Facility:
Name:
Guthrie Robert Packer Hospital /ID# 262758
Address:
City:
Sayre
Zip:
18840
Country:
United States
Status:
Recruiting
Facility:
Name:
Renovatio clinical /ID# 262000
Address:
City:
El Paso
Zip:
79915-1803
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology - Plano East /ID# 264356
Address:
City:
Plano
Zip:
75075
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology, P. A. /ID# 264311
Address:
City:
San Antonio
Zip:
78240-5251
Country:
United States
Status:
Recruiting
Facility:
Name:
Renovatio Clinical /ID# 261999
Address:
City:
The Woodlands
Zip:
77380-3181
Country:
United States
Status:
Recruiting
Facility:
Name:
Vista Oncology - East Olympia /ID# 262303
Address:
City:
Olympia
Zip:
98506-5028
Country:
United States
Status:
Recruiting
Facility:
Name:
The Canberra Hospital /ID# 261891
Address:
City:
Garran
Zip:
2605
Country:
Australia
Status:
Recruiting
Facility:
Name:
Nepean Hospital /ID# 262157
Address:
City:
Kingswood
Zip:
2747
Country:
Australia
Status:
Recruiting
Facility:
Name:
Westmead Hospital /ID# 261894
Address:
City:
Westmead
Zip:
2145
Country:
Australia
Status:
Recruiting
Facility:
Name:
Rambam Health Care Campus /ID# 262431
Address:
City:
Haifa
Zip:
3109601
Country:
Israel
Status:
Recruiting
Facility:
Name:
Shaare Zedek Medical Center /ID# 262432
Address:
City:
Jerusalem
Zip:
91031
Country:
Israel
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital East /ID# 261923
Address:
City:
Kashiwa-shi
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
Saitama Cancer Center /ID# 262703
Address:
City:
Kitaadachi-gun
Zip:
362-0806
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital /ID# 261925
Address:
City:
Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Facility:
Name:
Pan American Center for Oncology Trials /ID# 269666
Address:
City:
Rio Piedras
Zip:
00935
Country:
Puerto Rico
Status:
Recruiting
Facility:
Name:
National Cheng Kung University Hospital /ID# 262016
Address:
City:
Tainan
Zip:
704
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Mackay Memorial Hospital /ID# 262534
Address:
City:
Taipei City
Zip:
104
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taipei Medical University Hospital /ID# 262020
Address:
City:
Taipei City
Zip:
11031
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Linkou Chang Gung Memorial Hospital /ID# 262535
Address:
City:
Taoyuan City
Zip:
333
Country:
Taiwan
Status:
Recruiting
Start date:
April 10, 2024
Completion date:
October 8, 2031
Lead sponsor:
Agency:
AbbVie
Agency class:
Industry
Source:
AbbVie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06236438
https://www.abbvieclinicaltrials.com/study/?id=M23-721
