Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505773-32-00 | Other Identifier | EU CT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1 (Cohort 1): Livmoniplimab Dose A | Experimental | Participants will receive livmoniplimab (dose A)+ budigalimab, + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed. |
|
| Stage 1 (Cohort 2): Livmoniplimab Dose B | Experimental | Participants will receive livmoniplimab (dose B) + budigalimab, + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed. |
|
| Stage 1 (Cohort 3): Budigalimab | Experimental | Participants will receive budigalimab + chemotherapy for 4 cycles followed by budigalimab + pemetrexed. |
|
| Stage 1 (Cohort 4): Pembrolizumab | Experimental | Participants will receive pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed. |
|
| Stage 2 (Arm 1): Livmoniplimab (Dose Optimized) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Livmoniplimab | Drug | Intravenously (IV) Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR) | BOR of CR/PR is defined as achieving CR or PR according to response evaluation criteria in solid tumors (RECIST) v1.1 as determined by investigators at any time prior to subsequent anticancer therapy. Objective response rate (ORR), defined as the percentage of participants with a BOR of CR/PR, will be summarized. | Up to 21 Months |
| Stage 2: Overall Survival (OS) | OS is defined as the time measured from randomization until death from any cause. | Up to 55 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Stage 1: Progression Free Survival (PFS) | PFS is defined as the time measured from randomization until the first documentation of progressive disease (PD) according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first. | Up to 21 Months |
| Stage 1: Duration of Response (DOR) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Received prior systemic therapy for the treatment of metastatic NSCLC.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moores Cancer Center /ID# 267782 | Recruiting | La Jolla | California | 92037 | United States | |
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.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Not provided
Not provided
Not provided
Not provided
Not provided
| Experimental |
Participants will receive livmoniplimab (dose optimized) + budigalimab + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed. |
|
| Stage 2 (Arm 2): Placebo | Experimental | Participants will receive placebo + pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed. |
|
|
| Budigalimab | Drug | IV Infusion |
|
|
| Pembrolizumab | Drug | IV Infusion |
|
| Pemetrexed | Drug | IV Infusion |
|
| Cisplatin | Drug | IV Infusion |
|
| Carboplatin | Drug | IV Injection |
|
| Carboplatin | Drug | IV Infusion |
|
DOR is defined as the time from first CR/PR until the first documentation of PD according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first. |
| Up to 21 Months |
| Stage 1: OS | OS is defined as the time measured from randomization until death from any cause. | Up to 21 Months |
| Stage 2: PFS | PFS is defined as the time measured from randomization until the first documentation of progressive disease according to RECIST 1.1 as determined by blinded independent central review (BICR) or death from any cause, whichever occurs first. | Up to 55 Months |
| Stage 2: BOR of CR/PR | BOR of CR/PR is defined as achieving CR or PR according to RECIST 1.1 as determined by investigators at any time prior to subsequent anticancer therapy. ORR, defined as the percentage of participants with a BOR of CR/PR, will be summarized. | 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) | The EORTC QLQ-F17, a shorter, 17-item version that includes only the functional scales and the Global Health Status / Quality of Life scale of the EORTC QLQ-C30. QLQ-F17 includes the Physical (PF), Role (RF), Emotional (EF), Cognitive (CF) and Social Functioning (SF) scales as well as the Global Health Status/Quality of Life (QL) scale in their original wording. Participants rate items on a 4 point scale ranging form 1 to 4 (1- Not at All, 2= A Little, 3 = Quite a Bit, and 4= Very Much). | Up to 55 Months |
| Stage 2: Change from Baseline in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) | The NSCLC -SAQ scale with seven items assessing 5 symptoms of NSCLC (cough, pain, dyspnea, fatigue and poor appetites). The recall period is "over the last 7 days." Each item has a 5-point verbal rating scale from either 0 "No <symptom> at All" to 4 "Very severe <symptom>" or from 0 "Never" to 4 "Always," depending on the item's format. | 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 | The EORTC QLQ-F17, a shorter, 17-item version that includes only the functional scales and the Global Health Status / Quality of Life scale of the EORTC QLQ-C30. QLQ-F17 includes the Physical (PF), Role (RF), Emotional (EF), Cognitive (CF) and Social Functioning (SF) scales as well as the Global Health Status/Quality of Life (QL) scale in their original wording. Participants rate items on a 4 point scale ranging form 1 to 4 (1- Not at All, 2= A Little, 3 = Quite a Bit, and 4= Very Much). | Up to 55 Months |
| Stage 2: PFS per Investigator | PFS is defined as the time measured from randomization until the first documentation of progressive disease according to RECIST 1.1 as determined by the investigator or death from any cause, whichever occurs first. | Up to 55 Months |
| Stage 1: BOR of CR/PR per Investigator | BOR of CR/PR is defined as achieving CR or PR according to RECIST 1.1 as determined by investigators. ORR, defined as the percentage of participants with a BOR of CR/PR, will be summarized. | Up to 21 Months |
| Stage 2: DOR | DOR is defined as the time from first CR/PR until the first documentation of PD according to RECIST 1.1 as determined by BICR or death from any cause, whichever occurs first. | Up to 55 Months |
| Stage 2: DOR per investigator | DOR is defined as the time from first CR/PR until the first documentation of PD according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first. | Up to 55 Months |
| Memorial Hospital West /ID# 262221 |
| Recruiting |
| Pembroke Pines |
| Florida |
| 33028 |
| United States |
| Bond Clinic /ID# 262611 | Recruiting | Winter Haven | Florida | 33880 | United States |
|
| University Cancer & Blood Cent /ID# 261824 | Recruiting | Athens | Georgia | 30607 | United States |
| The University of Chicago Medical Center /ID# 262259 | Recruiting | Chicago | Illinois | 60637-1443 | United States |
| University of Kansas Medical Center /ID# 263196 | Recruiting | Westwood | Kansas | 66205 | United States |
| Baptist Health Lexington /ID# 261823 | Recruiting | Lexington | Kentucky | 40503 | United States |
| Cancer & Hematology Centers of Western Michigan - East /ID# 261826 | Recruiting | Grand Rapids | Michigan | 49546-7062 | United States |
|
| Washington University-School of Medicine /ID# 262759 | Recruiting | St Louis | Missouri | 63110 | United States |
| Stony Brook Cancer Center /ID# 261954 | Recruiting | Stony Brook | New York | 11794-0001 | United States |
| Cone Health Cancer Center /ID# 262583 | Recruiting | Greensboro | North Carolina | 27403-1109 | United States |
| Oncology Hematology Care, Inc - Blue Ash /ID# 262733 | Recruiting | Cincinnati | Ohio | 45252 | United States |
| Guthrie Robert Packer Hospital /ID# 262758 | Recruiting | Sayre | Pennsylvania | 18840 | United States |
| Renovatio clinical /ID# 262000 | Completed | El Paso | Texas | 79915-1803 | United States |
| Houston Methodist Hospital /ID# 262722 | Recruiting | Houston | Texas | 77030 | United States |
| Texas Oncology - Plano East /ID# 264356 | Recruiting | Plano | Texas | 75075 | United States |
| Texas Oncology - San Antonio Medical Center - Research Drive /ID# 264311 | Recruiting | San Antonio | Texas | 78240 | United States |
| Renovatio Clinical /ID# 261999 | Completed | The Woodlands | Texas | 77380-3181 | United States |
| Vista Oncology - East Olympia /ID# 262303 | Recruiting | Olympia | Washington | 98506-5028 | United States |
| Canberra Hospital /ID# 261891 | Recruiting | Garran | Australian Capital Territory | 2605 | Australia |
| Nepean Hospital /ID# 262157 | Recruiting | Kingswood | New South Wales | 2747 | Australia |
| Westmead Hospital /ID# 261894 | Recruiting | Westmead | New South Wales | 2145 | Australia |
| Universitair Ziekenhuis Antwerpen /ID# 261270 | Recruiting | Edegem | Antwerpen | 2650 | Belgium |
| Cliniques Universitaires UCL Saint-Luc /ID# 261267 | Recruiting | Brussels | Brussels Capital | 1200 | Belgium |
| Hospital La Louviere Site Jolimont - Helora /ID# 261269 | Recruiting | La Louvière | Hainaut | 7100 | Belgium |
| Groupe Sante CHC - Clinique du MontLegia /ID# 262338 | Recruiting | Liège | Liege | 4000 | Belgium |
| AZ Maria Middelares /ID# 262313 | Recruiting | Ghent | 9000 | Belgium |
| UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 262557 | Recruiting | Namur | 5000 | Belgium |
| Centro de Investigacion y Desarrollo Oncologico /ID# 261800 | Recruiting | Temuco | Araucania | 4810218 | Chile |
| Oncored /Id# 261801 | Recruiting | Vitacura | Region Metropolitana Santiago | 7650027 | Chile |
| Fundacion Arturo Lopez Perez /ID# 261700 | Recruiting | Providencia | Santiago Metropolitan | 7500921 | Chile |
| Sociedad Cem-Cancer Spa /Id# 262316 | Recruiting | Viña del Mar | Valparaiso | 2520598 | Chile |
| Hospital Clinico Universidad De Los Andes /ID# 262665 | Recruiting | Santiago | 7501504 | Chile |
| APHM - Hopital Nord /ID# 261129 | Recruiting | Marseille | Bouches-du-Rhone | 13015 | France |
| CHU Grenoble - Hopital Michallon /ID# 261131 | Recruiting | La Tronche | Isere | 38700 | France |
| Institut Curie /ID# 261127 | Recruiting | Paris | Paris | 75248 | France |
| Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 261644 | Recruiting | Bron | Rhone | 69500 | France |
| Centre Hosp Intercommunal de Creteil /ID# 261130 | Recruiting | Créteil | Val-de-Marne | 94000 | France |
| Shaare Zedek Medical Center /ID# 262432 | Recruiting | Jerusalem | Jerusalem | 91031 | Israel |
| Rambam Health Care Campus /ID# 262431 | Recruiting | Haifa | 3109601 | Israel |
| National Cancer Center Hospital East /ID# 261923 | Recruiting | Kashiwa-shi | Chiba | 277-8577 | Japan |
| Saitama Prefectural Cancer Center /ID# 262703 | Recruiting | Kitaadachi-gun | Saitama | 362-0806 | Japan |
| National Cancer Center Hospital /ID# 261925 | Recruiting | Chuo-ku | Tokyo | 104-0045 | Japan |
| Ziekenhuis St. Jansdal /ID# 261193 | Recruiting | Harderwijk | Gelderland | 3844 DG | Netherlands |
| Zuyderland Medisch Centrum /ID# 261190 | Recruiting | Heerlen | Limburg | 6419 PC | Netherlands |
| Isala /ID# 262458 | Recruiting | Zwolle | Overijssel | 8025 AB | Netherlands |
| Pan American Center for Oncology Trials /ID# 269666 | Recruiting | Rio Piedras | 00935 | Puerto Rico |
| Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 262723 | Recruiting | Santiago de Compostela | A Coruna | 15706 | Spain |
| Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 262118 | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| UOMi Cancer Center - Clinica Tres Torres /ID# 262116 | Recruiting | Barcelona | 08017 | Spain |
| Hospital Universitario Vall de Hebron /ID# 262113 | Recruiting | Barcelona | 08035 | Spain |
| Hospital General Universitario Gregorio Maranon /ID# 262114 | Recruiting | Madrid | 28007 | Spain |
| Hospital Universitario 12 de Octubre /ID# 262112 | Recruiting | Madrid | 28041 | Spain |
| Hospital Clinico Universitario de Valencia /ID# 262115 | Recruiting | Valencia | 46010 | Spain |
| National Cheng Kung University Hospital /ID# 262016 | Recruiting | Tainan | 704 | Taiwan |
| Mackay Memorial Hospital /ID# 262534 | Recruiting | Taipei | 104 | Taiwan |
| Taipei Medical University Hospital /ID# 262020 | Recruiting | Taipei | 11031 | Taiwan |
| Linkou Chang Gung Memorial Hospital /ID# 262535 | Recruiting | Taoyuan City | 333 | Taiwan |
| Gazi University Medical Faculty /ID# 261786 | Recruiting | Ankara | 06560 | Turkey (Türkiye) |
| Ankara City Hospital /ID# 261785 | Recruiting | Ankara | 06800 | Turkey (Türkiye) |
| Dr. Suat Seren Gogus Has /ID# 261789 | Recruiting | Izmir | 35110 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000719868 | budigalimab |
| C582435 | pembrolizumab |
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
Not provided
Not provided