An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination with Budigalimab in Advanced or Metastatic Non-Squamous NSCLC with No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations (AndroMETa-Lung-536)

Conditions

Advanced or Metastatic Non-Squamous NSCLC

Brief summary

Part 1: dose-limiting toxicity., Part 2: efficacy endpoint is the OR as assessed by BICR (as confirmed CR or PR based on RECIST v1.1).

Detailed description

Progression Free Survival (PFS): the time from the subject's randomization date to the first occurrence of radiographic progression per BICR based on RECIST v1.1 or death from any cause, whichever occurs earlier., Duration Of Response (DOR): the time from the first documented CR or PR per BICR to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause, whichever occurs first., Disease Control: best overall response of confirmed CR or confirmed PR, or SD for at least 12 weeks following randomization date based on RECIST v1.1, by the BICR. OR, PFS, DOR, and DC by investigator per RECIST v1.1., Overall Survival: the time from subject's randomization date (Part 2) or first dose date of study treatment (Part 1) to the event of death from any cause. Subjects with no documented death will be censored at the last known alive date., OR, PFS, OS, DOR, and DC in PD-L1 subgroups.

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGBudigalimab

DRUGCarboplatin 10 mg/ml Intravenous Infusion

DRUGALIMTA 500 mg powder for concentrate for solution for infusion

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGABBV-400

DRUGCisplatin 1mg/ml Injection BP

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part 1: dose-limiting toxicity., Part 2: efficacy endpoint is the OR as assessed by BICR (as confirmed CR or PR based on RECIST v1.1).	—

Secondary

Measure	Time frame
Progression Free Survival (PFS): the time from the subject's randomization date to the first occurrence of radiographic progression per BICR based on RECIST v1.1 or death from any cause, whichever occurs earlier., Duration Of Response (DOR): the time from the first documented CR or PR per BICR to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause, whichever occurs first., Disease Control: best overall response of confirmed CR or confirmed PR, or SD for at least 12 weeks following randomization date based on RECIST v1.1, by the BICR. OR, PFS, DOR, and DC by investigator per RECIST v1.1., Overall Survival: the time from subject's randomization date (Part 2) or first dose date of study treatment (Part 1) to the event of death from any cause. Subjects with no documented death will be censored at the last known alive date., OR, PFS, OS, DOR, and DC in PD-L1 subgroups.	—

Measure

Time frame

Progression Free Survival (PFS): the time from the subject's randomization date to the first occurrence of radiographic progression per BICR based on RECIST v1.1 or death from any cause, whichever occurs earlier., Duration Of Response (DOR): the time from the first documented CR or PR per BICR to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause, whichever occurs first., Disease Control: best overall response of confirmed CR or confirmed PR, or SD for at least 12 weeks following randomization date based on RECIST v1.1, by the BICR. OR, PFS, DOR, and DC by investigator per RECIST v1.1., Overall Survival: the time from subject's randomization date (Part 2) or first dose date of study treatment (Part 1) to the event of death from any cause. Subjects with no documented death will be censored at the last known alive date., OR, PFS, OS, DOR, and DC in PD-L1 subgroups.

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Countries

Belgium, France, Germany, Italy, Poland, Romania, Spain

Outcome results

None listed