Non-Small Cell Lung CancerPhase 3NCT07756645
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 Phase 3 study testing ABBV-1480, Pembrolizumab and Carboplatin in people with Non-Small Cell Lung Cancer, run by AbbVie at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- ABBV-1480, Pembrolizumab and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 940 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 22 Sep 2026to Dec 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Fort Wayne Medical Oncology And Hematology /ID# 286501
Fort Wayne, Indiana, 46804
Puerto Rico1 site, 1 recruiting
- Recruiting
Pan American Center for Oncology Trials - Rio Piedras /ID# 284017
Rio Piedras, 00935
About this study
Official title: 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
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.
Read more
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
- Being tested
- ABBV-1480, Pembrolizumab, Carboplatin, Paclitaxel, Nab- Paclitaxel
- Keywords
- Non-Small Cell Lung Cancer, ABBV-1480, Pembrolizumab, Chemotherapy, Carboplatin, Paclitaxel, Nab-Paclitaxel
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-1480Drug
Intravenous (IV)
PembrolizumabDrug
Intravenous (IV)
CarboplatinDrug
Intravenous (IV)
PaclitaxelDrug
Intravenous (IV)
Nab- PaclitaxelDrug
Intravenous (IV)
| Study group | Role | What they receive |
|---|---|---|
| ABBV-1480 + chemotherapy | Experimental | Participants will receive ABBV-1480 + chemotherapy (carboplatin and paclitaxel/nab-paclitaxel) Receives: Drug: ABBV-1480; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab- Paclitaxel |
| Pembrolizumab + chemotherapy | Experimental | Participants will receive Pembrolizumab + chemotherapy(carboplatin and paclitaxel/nab-paclitaxel) Receives: Drug: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab- Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to Approximately 60 Months
Secondary outcomes (14)
Objective Response Rate (ORR) assessed by blinded independent central review (BICR)
ORR is defined as the percentage of participants with a confirmed Complete Response or Partial Response (PR) per investigator review according to response evaluation criteria in solid tumors (RECIST) version 1.1.
Measured: Up to Approximately 60 Months
Change from baseline at Week 12 in physical functioning as measured by the EORTC QLQ-C30
The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items. Participants rate items on a 4-point scale ranging from 1 (not at all) to 4 (very much).
Measured: Up to Approximately 12 weeks
Change from baseline at Week 12 in GHS/QoL as measured by the EORTC QLQ-C30.
Health-related quality-of-life and symptoms will be assessed with the EORTC QLQ-C30, version 3.0. The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a GHS/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4 point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much).
Measured: Up to Approximately 12 Weeks
Duration Of Response (DoR) assessed by Blinded Independent Central Review (BICR)
Duration Of Response (DoR) defined as time from the first documented Complete Response (CR) or Partial Response (PR) to the first occurrence of radiographic progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurs first. DoR is defined for subjects with confirmed CR/PR.
Measured: Up to Approximately 60 months
Disease Control Rate (DCR) assessed by Blinded Independent Central Review (BICR)
Disease Control Rate (DCR) is defined as best overall response of confirmed Complete Response (CR) or confirmed Partial Response (PR) or Stable Disease (SD) based on Response Evaluation Criteria in Solid Tumors (RECIST) version1.1
Measured: Up to Approximately 60 Months
Time To Response (TTR) assessed by Blinded Independent Central Review (BICR)
Time To Response (TTR) is defined as the number of months from the date of first dose to the date of best overall response of Complete Response (CR) or Partial Response (PR)
Measured: Up to Approximately 60 months
Progression-Free Survival (PFS) assessed by the investigator
Progression-Free Survival (PFS) is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST v1.1 or death from any cause, whichever occurs earlier.
Measured: Up to Approximately 60 Months
Objective Response Rate (ORR) assessed by the investigator
Objective Response Rate (ORR) is defined as the percentage of participants with a confirmed Complete Response or Partial Response (PR) per investigator review according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
Measured: Up to Approximately 60 Months
Duration Of Response (DoR) assessed by the investigator
Duration Of Response (DoR) defined as time from the first documented Complete Response (CR) or Partial Response (PR) to the first occurrence of radiographic progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurs first. DoR is defined for subjects with confirmed CR/PR.
Measured: Up to Approximately 24 months
DCR assessed by the investigator
Disease Control Rate (DCR) is defined as best overall response of confirmed Complete Response (CR) or confirmed Partial Response (PR) or Stable Disease (SD) based on Response Evaluation Criteria in Solid Tumors (RECIST) version1.1
Measured: Up to Approximately 60 Months
TTR assessed by the investigator
Time To Response (TTR) is defined as the number of months from the date of first dose to the date of best overall response of Complete Response (CR) or Partial Response (PR)
Measured: Up to Approximately 60 months
Change from baseline at Week 12 in the coughing item as measured by the EORTC QLQ-LC13.
The EORTC QLQ-LC13 is a lung cancer specific module and consists of 13 questions assessing lung cancer-associated symptoms and treatment-related effects, including one multiple-item scale to assess dyspnea and a series of single items assessing coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain, and pain medication. Each item is assessed on a Likert scale from 1 (not at all) to 4 (very much).
Measured: Up to Approximately 12 Weeks
Change from baseline at Week 12 in the pain in chest item as measured by the EORTC QLQLC13
The EORTC QLQ-LC13 is a lung cancer specific module and consists of 13 questions assessing lung cancer-associated symptoms and treatment-related effects, including one multiple-item scale to assess dyspnea and a series of single items assessing coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain, and pain medication. Each item is assessed on a Likert scale from 1 (not at all) to 4 (very much).
Measured: Up to Approximately 12 weeks
Change in from baseline at Week 12 in dyspnea items as measured by the EORTC QLQ-LC13
The EORTC QLQ-LC13 is a lung cancer specific module and consists of 13 questions assessing lung cancer-associated symptoms and treatment-related effects, including one multiple-item scale to assess dyspnea and a series of single items assessing coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain, and pain medication. Each item is assessed on a Likert scale from 1 (not at all) to 4 (very much).
Measured: Up to Approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start22 Sep 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 940 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756645
- Sponsor's protocol ID
- M26-509
- Other IDs
- 2026-526573-42-00
- Status last verified
- Oct 2026
- First submitted
- 7 Aug 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.