A Phase 3 interventional study of ABBV-1480 and Pembrolizumab in Non-Small Cell Lung Cancer, sponsored by AbbVie. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
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.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 940 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive ABBV-1480 + chemotherapy (carboplatin and paclitaxel/nab-paclitaxel)
Drug: ABBV-1480 · Drug: Carboplatin · Drug: Paclitaxel · Drug: Nab- Paclitaxel
Participants will receive Pembrolizumab + chemotherapy(carboplatin and paclitaxel/nab-paclitaxel)
Drug: Pembrolizumab · Drug: Carboplatin · Drug: Paclitaxel · Drug: Nab- Paclitaxel
Intravenous (IV)
Intravenous (IV)
Intravenous (IV)
Intravenous (IV)
Intravenous (IV)
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.
Time frame: 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.
Time frame: Up to Approximately 60 Months
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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Up to Approximately 12 weeks
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
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/
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2029, 39 months later.
Of 314 industry-sponsored phase 3 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 57. This study's planned 39 months is close to that.
Counting every sponsor, half of 423 studies reached it within 45 months; a quarter within 30 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Carcinoma, Non-Small-Cell Lung →