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NCT Number: NCT06772623

Study 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

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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Key information

Conditions

Non Small Cell Lung Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Groupe Sante CHC - Clinique du MontLegia /ID# 271760, Liège, Liege, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must have histologically documented non-squamous (NSq) non small cell lung carcinoma (NSCLC) that is locally advanced or metastatic will be enrolled into the study.
  • Must have measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.
  • For Part 1, participants must have had no more than 1 systemic therapy for advanced disease including platinum-based chemotherapy or an immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy), or appropriate targeted therapy for an actionable gene alteration, if applicable, for epidermal growth factor receptor (EGFR) wild-type (WT) NSq NSCLC.
  • For Part 2, participants must have no prior systemic therapy for advanced disease, no known actionable genomic alteration.
  • 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 randomization.
  • Must have adequate organ function.

Exclusion criteria

  • Known uncontrolled metastases to the central nervous system.
  • History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis on screening chest computed tomography (CT) scan.

Treatment and study plan

Telisotuzumab Adizutecan

Drug

Intravenous (IV) Infusion

Other names: ABBV-400

Budigalimab

Drug

IV Infusion

Other names: ABBV-181

Pembrolizumab

Drug

IV Injection

carboplatin

Drug

IV Infusion

Pemetrexed

Drug

IV Infusion

Cisplatin

Drug

IV Infusion

Primary outcomes

  1. Part 1: Dose-Limiting Toxicities (DLT)s of Telisotuzumab Adizutecan

    Time frame: Up to Approximately 84 Days

    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.

  2. Part 2: Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)

    Time frame: Up to Approximately 33 Months

    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.

  3. Number of Participants with Adverse Events (AE)s

    Time frame: Up to Approximately 33 Months

    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.

Secondary outcomes

  1. Part 1 and Part 2: PFS as Assessed by Investigator

    Time frame: Up to Approximately 33 Months

    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.

  2. Part 1 and Part 2: DOR as Assessed by Investigator

    Time frame: Up to Approximately 33 Months

    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.

  3. Part 1 and Part 2: DC as Assessed by Investigator

    Time frame: Up to Approximately 33 Months

    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.

  4. Part 1 and Part 2: Overall Survival (OS)

    Time frame: Up to Approximately 33 Months

    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.

  5. Programmed Death Ligand 1 (PD-L1) and c-Met Subgroups: OR

    Time frame: Up to Approximately 33 Months

    OR is defined as confirmed CR or confirmed PR based on RECIST v1.1.

  6. PD-L1 and c-Met Subgroups: PFS

    Time frame: Up to Approximately 33 Months

    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.

  7. PD-L1 and c-Met Subgroups: OS

    Time frame: Up to Approximately 33 Months

    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.

  8. PD-L1 and c-Met Subgroups: DOR

    Time frame: Up to Approximately 33 Months

    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.

  9. PD-L1 and c-Met Subgroups: DC

    Time frame: Up to Approximately 33 Months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 13, 2025
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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