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Study for Metastatic Non-Small Cell Lung Cancer

This study is for adults with untreated metastatic non-squamous non-small cell lung cancer (NSCLC), a type of lung cancer that has spread. It's looking at the safety, best dose, and effectiveness of two investigational drugs, livmoniplimab and budigalimab, when given with chemotherapy (pemetrexed and cisplatin). This combination is being compared to pembrolizumab plus chemotherapy. You may be eligible if your cancer does not have certain genetic changes (ALK or EGFR mutations). The study aims to see how many people respond to treatment (tumor shrinkage) and how long people live. The study is currently unclear on its recruitment status and plans to enroll 840 participants.

Study design
This interventional study has two stages and will involve 840 participants. In Stage 1, participants will be assigned to one of four treatment groups, receiving different combinations of investigational drugs and chemotherapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track how well treatments work for up to 21 months and overall survival for up to 55 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06236438

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)

Recruiting
PHASE2Ages 18+InterventionalTreatment
AbbVie
~840 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:LivmoniplimabBudigalimabPembrolizumabPemetrexedCisplatinCarboplatin

At a glance

Recruiting sites
56 of 61 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR)
Measured over Up to 21 Months
+1 more outcome measured

Conditions

Non-Small Cell Lung Cancer

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

61 sites across 45 states
Texas5
Spain5
Taiwan4
Turkey (Türkiye)3
Florida2
New South Wales2
Belgium2
California1

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR)Up to 21 Months

    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.

  • Stage 2: Overall Survival (OS)Up to 55 Months

    OS is defined as the time measured from randomization until death from any cause.