A Study to Assess Intravenous ABBV-1480 Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First Line Treatment of Locally Advanced/Metastatic Non-Small Cell Lung Cancer in Adult Participants
ABBV-1480, an investigational agent whose mechanism is not stated in the registry, is being studied in combination with platinum-based chemotherapy versus pembrolizumab plus chemotherapy as first-line treatment for locally advanced or metastatic squamous non-small cell lung cancer.
NCT07756645 · Phase 3 · AbbVie
Recruiting sites: Indiana
Read full eligibility criteria
Inclusion Criteria:
* Adult subjects with a histologically or cytologically confirmed diagnosis of Stage IIIB, IIIC, or IV sqNSCLC that is not amenable to curative treatment
* At least one lesion with measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by the local site investigator/radiology assessment.
* Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Adequate hematological, renal, hepatic, and coagulation function.
* Females of childbearing potential must have a negative pregnancy test
Exclusion Criteria:
* Prior systemic treatment received for locally advanced or metastatic NSCLC.
* Histologically or cytologically confirmed non-sqNSCLC.
* Known actionable genomic alterations (including EGFR, ALK, ROS1, BRAF, NTRK, RET, and MET) for which first-line approved therapies are available.
* Active central nervous system (CNS) metastases and/or carcinomatous meningitis.