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

NCT07756645 | Not Yet Recruiting Phase 3 FDA Drug

• 2 other identifiers: M26-5092026-526573-42-00
• Study Type: interventional
• Target: 940
• Locations: 0 countries
• Sites: N/A

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Progression-Free Survival (PFS) assessed by the Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  Progression-Free Survival (PFS) is defined as the time from randomization to the first occurrence of radiographic progression as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by Blinded Independent Central Review (BICR) or death from any cause, whichever occurs first.

  Up to Approximately 60 Months

• Overall Survival (OS)

  Overall Survival (OS) is defined as the time from randomization to the event of death from any cause.

  Up to Approximately 60 Months

Secondary Outcomes (14)

• Objective Response Rate (ORR) assessed by blinded independent central review (BICR)

  Up to Approximately 60 Months

• Change from baseline at Week 12 in physical functioning as measured by the EORTC QLQ-C30

  Up to Approximately 12 weeks

• Change from baseline at Week 12 in GHS/QoL as measured by the EORTC QLQ-C30.

  Up to Approximately 12 Weeks

• Duration Of Response (DoR) assessed by Blinded Independent Central Review (BICR)

  Up to Approximately 60 months

• Disease Control Rate (DCR) assessed by Blinded Independent Central Review (BICR)

  Up to Approximately 60 Months

Study Arms (2)

ABBV-1480 + chemotherapy

EXPERIMENTAL

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

Drug: ABBV-1480; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab- Paclitaxel

Pembrolizumab + chemotherapy

EXPERIMENTAL

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

Drug: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab- Paclitaxel

Interventions

ABBV-1480 DRUG

Intravenous (IV)

ABBV-1480 + chemotherapy

Pembrolizumab DRUG

Intravenous (IV)

Pembrolizumab + chemotherapy

Carboplatin DRUG

Intravenous (IV)

ABBV-1480 + chemotherapy; Pembrolizumab + chemotherapy

Paclitaxel DRUG

Intravenous (IV)

ABBV-1480 + chemotherapy; Pembrolizumab + chemotherapy

Nab- Paclitaxel DRUG

Intravenous (IV)

ABBV-1480 + chemotherapy; Pembrolizumab + chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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. - Actionable genomic alteration testing results for EGFR and ALK are required before randomization.
• Active central nervous system (CNS) metastases and/or carcinomatous meningitis.

Sponsors & Collaborators

• AbbVie: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab; Carboplatin; Paclitaxel; Taxes

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): September 22, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/