Lung Cancer Clinical Trial

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)

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.

View Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

840

Study ID:

NCT06236438

Recruitment Status:

Recruiting

Sponsor:

AbbVie

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There are 7 Locations for this study

See Locations Near You

Bond Clinic /ID# 262611
Winter Haven Florida, 33880, United States More Info
Site Coordinator
Contact
863-293-1191 ex 3790
University Cancer & Blood Cent /ID# 261824
Athens Georgia, 30607, United States
Cancer & Hematology Centers of Western Michigan - East /ID# 261826
Grand Rapids Michigan, 49546, United States More Info
Site Coordinator
Contact
616-975-3065
Vista Oncology - East Olympia /ID# 262303
Olympia Washington, 98506, United States
Rambam Health Care Campus /ID# 262431
Haifa H_efa, 31096, Israel
Shaare Zedek Medical Center /ID# 262432
Jerusalem Yerushalayim, 91031, Israel
Saitama Cancer Center /ID# 262703
Kitaadachi-gun Saitama, 362-0, Japan

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

840

Study ID:

NCT06236438

Recruitment Status:

Recruiting

Sponsor:


AbbVie

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