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Telisotuzumab Adizutecan / Budigalimab / Non Small Cell Lung Carcinoma · Phase 1/2 Trial
ClinicalTrials.gov · August 14, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a clinical trial registry record describing a planned Phase 1/2 study with no posted results. The study will evaluate telisotuzumab adizutecan combined with PD-1 checkpoint inhibitors in treatment-naive advanced non-squamous NSCLC, with dose escalation followed by randomized optimization against standard of care. No efficacy or safety data are available from this registry entry.
Phase 1/2, Interventional, Randomized, Sequential, Open label, Treatment purpose. Non Small Cell Lung Carcinoma; age from 18 Years. Intervention: Part 1: Telisotuzumab Adizutecan + Budigalimab; Part 2 Arm 1: Telisotuzumab Adizutecan + Pembrolizumab; Part 2 Arm 2: Telisotuzumab Adizutecan + Pembrolizumab; Part 2: Standard of Care. Compared with: Standard of care: pembrolizumab with pemetrexed and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed (Part 2 only). n = 252. 118 sites across 15 countries.
This is a clinical trial registry record describing a planned Phase 1/2 study with no posted results. The study will evaluate telisotuzumab adizutecan combined with PD-1 checkpoint inhibitors in treatment-naive advanced non-squamous NSCLC, with dose escalation followed by randomized optimization against standard of care. No efficacy or safety data are available from this registry entry.
Primary outcomes are dose-limiting toxicities (Part 1) and objective response plus adverse events (Part 2)—no efficacy or safety data are available from this source. Effect sizes, response rates, and adverse event frequencies are not provided in this registry entry.
Clinicians and researchers should note that this is a planned study with no results yet reported. This trial will generate preliminary evidence on safety and efficacy of a novel antibody-drug conjugate combined with checkpoint inhibitors in a treatment-naive population; results when available will be early-phase and require confirmation in later studies.
This is a Phase 1/2 trial registration with no posted results; it describes a planned dose-escalation and optimization study in a treatment-naive population, representing early-stage investigation of a novel combination.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians and researchers should note that this is a planned study with no results yet reported. This trial will generate preliminary evidence on safety and efficacy of a novel antibody-drug conjugate combined with checkpoint inhibitors in a treatment-naive population; results when available will be early-phase and require confirmation in later studies.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06772623). This is a study registration, not published results. Lead sponsor: AbbVie. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 252 participants (ESTIMATED). Conditions: Non Small Cell Lung Carcinoma. Interventions: DRUG: Telisotuzumab Adizutecan; DRUG: Budigalimab; DRUG: Pembrolizumab; DRUG: Pembrolizumab; DRUG: Carboplatin; DRUG: Pemetrexed; DRUG: Cisplatin. Primary outcome measures: Part 1: Dose-Limiting Toxicities (DLT)s of Telisotuzumab Adizutecan , Up to Approximately 84 Days; Part 2: Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR) , Up to Approximately 33 Months; Number of Participants with Adverse Events (AE)s , Up to Approximately 33 Months. Brief summary: 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.
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