A Phase 1/2 interventional study of Telisotuzumab Adizutecan and Budigalimab in Non Small Cell Lung Carcinoma and c-MET, sponsored by AbbVie. Recruiting at 127 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by AbbVie · Phase 1/2, Interventional, and Treatment
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Among 48 studies in Carcinoma, Non-Small-Cell Lung by AbbVie — 8 open to participants now, 14 under way, 5 of them phase 3. Carcinoma, Non-Small-Cell Lung · AbbVie.
Among the 48 studies in Carcinoma, Non-Small-Cell Lung by AbbVie, this one is the 12th largest by planned enrollment of the 46 interventional ones that give a count, is one of 3 that started in 2025, is one of 4 in phase 1/2, reaches primary completion later than 5 of the 13 other live ones, and was the 44th registered.
7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →8 of the 48 studies in Carcinoma, Non-Small-Cell Lung by AbbVie are open now, in 12 countries. Recruiting first, the newest first:
AbbVie · Sites in United States, Puerto Rico
Ages 18+
AbbVie · Sites in United States
Ages 18+
AbbVie · Sites in United States, Australia, Austria and 17 more countries
Ages 18+
AbbVie · Sites in United States, Brazil, China and 4 more countries
Ages 18+
AbbVie · Sites in United States, Argentina, Australia and 29 more countries
Ages 18+
By country, each count listing its studies:
Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
48 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 25 · Phase 2 18 · Phase 3 9
First in 2004; this study’s year is marked. 3 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 252 is above the median of 62 across 6,023 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 135 across the 46 interventional studies, 579 across the 1 observational. Of the 32 that completed or were terminated, 5 (16%) have results posted.
This tab as a report to print or save as PDF → With an account.
AbbVie is the lead sponsor of 977 studies on the registry; 136 are open to participants now.
Of its 358 completed or terminated interventional studies of FDA-regulated products, 215 (60%) have results posted.
4 of the studies in Carcinoma, Non-Small-Cell Lung by AbbVie that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03893955AbbVieA Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors | 2027-03 |
| NCT05005403AbbVieStudy to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan | 2027-07 |
| NCT06772623AbbVieStudy to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations | 2027-11 |
| NCT05029882AbbVieStudy to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 as Monotherapy and in Combination With IV Bevacizumab | 2027-11 |
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Among the 48 studies in Carcinoma, Non-Small-Cell Lung by AbbVie, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Non small cell lung carcinoma (NSCLC) is the most frequently occurring histologic subtype of lung cancer and is the leading cause of cancer-related deaths worldwide. The purpose of this study is to assess adverse events and change in disease activity when Telisotuzumab Adizutecan (ABBV-400) is given in combination with a programmed cell death receptor 1 (PD1) immune checkpoint inhibitor to adult participants to treat NSCLC.
Telisotuzumab Adizutecan (ABBV-400) and budigalimab are investigational drugs being developed for the treatment of NSCLC. This study will be divided into two stages, with the first stage treating participants with several doses of telisotuzumab adizutecan in combination with budigalimab within the dose escalation regimen until the dose reached is tolerable and expected to be efficacious. In Stage 2 there will be 3 treatment groups. Two groups will receive pembrolizumab with different optimized doses of telisotuzumab adizutecan (to allow for the best dose to be studied in the future). One group will receive the standard of care (SOC) - pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. Approximately 252 adult participants with NSCLC will be enrolled in the study in 132 sites worldwide.
In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of Telisotuzumab Adizutecan in combination with budigalimab until the dose of Telisotuzumab Adizutecan reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive IV optimized doses of Telisotuzumab Adizutecan in combination with IV pembrolizumab, or IV SOC - pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. The study will run for a duration of approximately 33 months.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
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.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive several doses of telisotuzumab adizutecan in combination with budigalimab, as part of the 33 month study duration.
Drug: Telisotuzumab Adizutecan · Drug: Budigalimab
Participants will receive telisotuzumab adizutecan dose A in combination with pembrolizumab, as part of the 33 month study duration.
Drug: Telisotuzumab Adizutecan · Drug: Pembrolizumab
Participants will receive telisotuzumab adizutecan dose B in combination with pembrolizumab, as part of the 33 month study duration.
Drug: Telisotuzumab Adizutecan · Drug: Pembrolizumab
Participants will receive pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed, as part of the 33 month study duration.
Drug: Pembrolizumab · Drug: Carboplatin · Drug: Pemetrexed · Drug: Cisplatin
Intravenous (IV) Infusion
Also known as: ABBV-400
IV Infusion
Also known as: ABBV-181
IV Injection
IV Infusion
IV Infusion
IV Infusion
IV Infusion
Part 1: Dose-Limiting Toxicities (DLT)s of Telisotuzumab Adizutecan
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
Time frame: Up to Approximately 84 Days
Part 2: Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)
OR is defined as confirmed complete response (CR) or confirmed partial response (PR) per BICR based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame: Up to Approximately 33 Months
Number of Participants with Adverse Events (AE)s
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time frame: Up to Approximately 33 Months
Part 1 and Part 2: PFS as Assessed by Investigator
PFS is defined as the time from the participant's randomization date to the first occurrence of radiographic progression per Investigator based on RECIST v1.1 or death from any cause, whichever occurs earlier.
Time frame: Up to Approximately 33 Months
Part 1 and Part 2: DOR as Assessed by Investigator
DOR is defined as the time from the first documented CR or PR per investigator to the first occurrence of radiographic progression per the investigator on RECIST v1.1 or death from any cause, whichever occurs first. DOR is defined for participants with confirmed CR/PR.
Time frame: Up to Approximately 33 Months
Part 1 and Part 2: DC as Assessed by Investigator
DC is defined as best overall response of confirmed CR or confirmed PR, or SD for at least 11 weeks following randomization date based on RECIST v1.1, as determined by the Investigator.
Time frame: Up to Approximately 33 Months
Part 1 and Part 2: Overall Survival (OS)
OS is defined as the time from participant's randomization date (Part 2) or first dose date of study treatment (Part 1) to the event of death from any cause.
Time frame: Up to Approximately 33 Months
Programmed Death Ligand 1 (PD-L1) and c-Met Subgroups: OR
OR is defined as confirmed CR or confirmed PR based on RECIST v1.1.
Time frame: Up to Approximately 33 Months
PD-L1 and c-Met Subgroups: PFS
PFS is defined as the time from the participant's randomization date 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 33 Months
PD-L1 and c-Met Subgroups: OS
OS is defined as the time from participant's randomization date (Part 2) or first dose date of study treatment (Part 1) to the event of death from any cause.
Time frame: Up to Approximately 33 Months
PD-L1 and c-Met Subgroups: DOR
DOR is defined as the time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause, whichever occurs first. DOR is defined for participants with confirmed CR/PR.
Time frame: Up to Approximately 33 Months
PD-L1 and c-Met Subgroups: DC
DC is defined as best overall response of confirmed CR or confirmed PR, or SD for at least 12 weeks following randomization date based on RECIST v1.1.
Time frame: Up to Approximately 33 Months
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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.
Started Mar 2025 (actual). Primary completion is estimated for Nov 2027, 32 months after the start.
Of 309 industry-sponsored phase 1/2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 77. This study's planned 32 months is below that.
Counting every sponsor, half of 432 studies reached it within 63 months; a quarter within 42 and three quarters within 80.
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 ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Telisotuzumab adizutecan
Carcinoma, Non-Small-Cell Lung →