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)
- Conditions
- ntreated Metastatic Non-Squamous Non-Small Cell Lung Cancer, Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer, Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer, Untreated Metastatic Non-Squamous Non-Small Cell Lung CancerMedDRA version: 20.0Level: LLTClassification code: 10079440Term: Non-squamous non-small cell lung cancer Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-505773-32-00
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
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., Participant has completed palliative radiotherapy > 7 days from the first dose of study treatment., 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., Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2., Participant has completed palliative radiotherapy > 7 days from the first dose of study treatment., 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., Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
Received prior systemic therapy for the treatment of metastatic NSCLC., Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia., Prior allogeneic stem cell or solid organ transplantation., History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins., History of positive test result(s) for hepatitis B (HBV) surface antigen or for hepatitis C (HCV) antibody., Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia., Received prior systemic therapy for the treatment of metastatic NSCLC., Prior allogeneic stem cell or solid organ transplantation., History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins., History of positive test result(s) for hepatitis B (HBV) surface antigen or for hepatitis C (HCV) antibody.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method