ABBV-1480 plus chemotherapy vs pembrolizumab plus chemotherapy as first-line treatment for locally advanced or metastatic non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial compares two first-line treatment approaches for adults with locally advanced or metastatic squamous NSCLC. Participants are randomized to receive either ABBV-1480 with platinum-based chemotherapy or pembrolizumab with platinum-based chemotherapy. The study aims to determine which combination more effectively controls disease and improves outcomes. It enrolls up to about 940 participants across numerous sites worldwide and focuses on patients whose disease is measurable and not amenable to curative treatment. Key eligibility requires good performance status and adequate organ function; prior systemic treatment for NSCLC is excluded.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fort Wayne Medical Oncology And Hematology /ID# 286501
  Fort Wayne, Indiana, United States Recruiting
• Pan American Center for Oncology Trials - Rio Piedras /ID# 284017
  Rio Piedras, Puerto Rico Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.