NCT07756645RecruitingPhase 3
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
A Randomized, Multiregional, Open-Label Phase 3 Clinical Trial of ABBV-1480 Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First Line Treatment of Locally Advanced/Metastatic Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 940 (estimated)
- First submitted
- 7 Aug 2026
- Start date
- 22 Sept 2026
- Primary completion date
- Dec 2029
- Lead sponsor
- AbbVie
- Diseases
- Lung cancer
- NCT number
- NCT07756645
- EU CT number
- 2026-526573-42-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 940
- From 22 Sept 2026 to the primary completion date, Dec 2029
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior systemic treatment received for locally advanced or metastatic NSCLC.
Lab values
- Known actionable genomic alterations (including EGFR, ALK, ROS1, BRAF, NTRK, RET, and MET) for which first-line approved therapies are available.
Other
- Histologically or cytologically confirmed non-sqNSCLC.
- Active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pan American Center for Oncology Trials - Rio Piedras /ID# 284017 Coordinator of this site? Confirm its status | Rio Piedras | Puerto Rico | Recruiting |
| Fort Wayne Medical Oncology And Hematology /ID# 286501 Coordinator of this site? Confirm its status | Fort Wayne | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.