At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Telisotuzumab Adizutecan (drug), Budigalimab (drug), Pembrolizumab (drug), Pembrolizumab (drug)
- How long the study runs
- Study runs about 32 months (dates as stated)
- About the drug or intervention
- Telisotuzumab Adizutecan — drug: Intravenous (IV) Infusion · Budigalimab — drug: IV Infusion · Pembrolizumab — drug: IV Injection · Pembrolizumab — drug: IV Infusion · Carboplatin — drug: IV Infusion · Pemetrexed — drug: IV Infusion · Cisplatin — drug: IV Infusion
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 252
- Started
- 2025-03-06
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for non small cell lung carcinoma
- • Phase1/Phase2 - 252 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with non small cell lung carcinoma
Where?
- • Leicester - University Hospitals of Leicester NHS Trust /ID# 276035
- • Cardiff - Velindre Cancer Centre /ID# 271840
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ measurable disease per response evaluation criteria in solid tumors (RECIST) v1
- ✓ no prior systemic therapy for advanced disease, no known actionable genomic alteration
- ✓ documented programmed death ligand 1 (PD-L1) status
- ✓ evaluable c-Met immunohistochemistry (IHC) result per central testing
What the study is looking for
- ✓Must have histologically documented non-squamous (NSq) non small cell lung carcinoma (NSCLC) that is locally...
- ✓Must have cancer that can be measured on scans per response evaluation criteria in solid tumors (RECIST) v1.1.
- ✓For Part 2, participants must have no prior treatment that goes through your whole body for advanced disease, no known actionable genomic...
- ✓Must have documented programmed death ligand 1 (PD-L1) status.
- ✓For Part 2, participant must have evaluable c-Met immunohistochemistry (IHC) result per central testing prior to...
Who cannot take part
- ✗Known uncontrolled metastases to the central nervous system.
- ✗History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any...
See the full criteria
Where Is This Study? (2 UK sites)
University Hospitals of Leicester NHS Trust /ID# 276035
Leicester LE1 5WW, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351Velindre Cancer Centre /ID# 271840
Cardiff CF14 2TL, United Kingdom
How to Get in Touch
ABBVIE CALL CENTER
Sponsor contactCONTACT