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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)
EU CTIS ID: 2023-505773-32-00
What this study is testing
- Stage 1 (Phase 2): To assess the safety and activity of livmoniplimab and budigalimab in combination with platinum doublet chemotherapy and to select recommended Phase 3 dose (RP3D) for livmoniplimab. - Stage 2 (Phase 3): To evaluate the activity of the RP3D of livmoniplimab and budigalimab in combination with platinum doublet chemotherapy versus pembrolizumab in combination with platinum doublet chemotherapy as measured by overall survival (OS).
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chile
- Australia
- Korea, Democratic People's Republic of
- Taiwan
- United States
- Japan
- Israel
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chile; Australia; Korea, Democratic People's Republic of; Taiwan; United States; Japan and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.