Recruiting
Phase 3

ABBV-1480 vs. Pembrolizumab

Sponsor:

AbbVie

Code:

NCT07756645

Conditions

Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ABBV-1480

Pembrolizumab

Carboplatin

Paclitaxel

Nab- Paclitaxel

Study Details

Brief summary:

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 80%-85% of lung cancers cases. Squamous carcinoma accounts for 20-30% of all NSCLC cases. The purpose of this study is to determine if ABBV-1480 plus chemotherapy works better than pembrolizumab plus chemotherapy in adult participants with NSCLC.

ABBV-1480 is an investigational drug being developed for the treatment of NSCLC. Participants will be randomized into 2 groups. One group will receive ABBV-1480 with platinum based chemotherapy. Another group will receive standard of care (SOC) pembrolizumab with platinum based chemotherapy. Up to approximately 940 adult participants with locally advanced (Stage IIIB/C) or metastatic (Stage IV) sqNSCLC, will be enrolled in the study in approximately 250 sites globally.

In this Phase 3 study one of two groups will receive doses of Intravenous (IV) ABBV-1480 + Carboplatin \& Paclitaxel/ Nab-paclitaxel and other group will receive Intravenous (IV) Pembrolizumab + Carboplatin \& Paclitaxel/ Nab-paclitaxel.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Conditions

Non-Small Cell Lung Cancer

Study ID

NCT07756645

Start date

Sep 22, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

940 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ABBV-1480 + chemotherapy

Participants will receive ABBV-1480 + chemotherapy (carboplatin and paclitaxel/nab-paclitaxel)

experimental: Pembrolizumab + chemotherapy

Participants will receive Pembrolizumab + chemotherapy(carboplatin and paclitaxel/nab-paclitaxel)

Interventions

ABBV-1480

Intravenous (IV)

Pembrolizumab

Intravenous (IV)

Carboplatin

Intravenous (IV)

Paclitaxel

Intravenous (IV)

Nab- Paclitaxel

Intravenous (IV)

Primary outcome measure

  • Progression-Free Survival (PFS) assessed by the Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to Approximately 60 Months ]
  • Overall Survival (OS) [ Time Frame: Up to Approximately 60 Months ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Fort Wayne Medical Oncology And Hematology /ID# 286501

Recruiting

Fort Wayne, Indiana, United States, 46804

More Information

Sponsor

AbbVie

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Keywords

  • Non-Small Cell Lung Cancer
  • ABBV-1480
  • Pembrolizumab
  • Chemotherapy
  • Carboplatin
  • Paclitaxel
  • Nab-Paclitaxel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-21. This information was provided to ClinicalTrials.gov by AbbVie on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.