Recruiting 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

Phase I / Phase II Interventional Non Small Cell Lung Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Telisotuzumab Adizutecan, Budigalimab, Pembrolizumab, Pembrolizumab.
Who it may be relevant to: Registry conditions: Non Small Cell Lung Carcinoma. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Belgium, China, France, Germany +9
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Interventions

Drug Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Drug Budigalimab
IV Infusion
Drug Pembrolizumab
IV Injection
Drug Pembrolizumab
IV Infusion
Drug Carboplatin
IV Infusion
Drug Pemetrexed
IV Infusion
Drug Cisplatin
IV Infusion

Primary outcome measures

Part 1: Dose-Limiting Toxicities (DLT)s of Telisotuzumab Adizutecan [Time frame: Up to Approximately 84 Days]
Part 2: Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR) [Time frame: Up to Approximately 33 Months]
Number of Participants with Adverse Events (AE)s [Time frame: Up to Approximately 33 Months]

Secondary outcome measures (9)

Part 1 and Part 2: PFS as Assessed by Investigator [Time frame: Up to Approximately 33 Months]
Part 1 and Part 2: DOR as Assessed by Investigator [Time frame: Up to Approximately 33 Months]
Part 1 and Part 2: DC as Assessed by Investigator [Time frame: Up to Approximately 33 Months]
Part 1 and Part 2: Overall Survival (OS) [Time frame: Up to Approximately 33 Months]
Programmed Death Ligand 1 (PD-L1) and c-Met Subgroups: OR [Time frame: Up to Approximately 33 Months]
PD-L1 and c-Met Subgroups: PFS [Time frame: Up to Approximately 33 Months]
PD-L1 and c-Met Subgroups: OS [Time frame: Up to Approximately 33 Months]
PD-L1 and c-Met Subgroups: DOR [Time frame: Up to Approximately 33 Months]
PD-L1 and c-Met Subgroups: DC [Time frame: Up to Approximately 33 Months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Sequential
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 27 centers

Mayo Clinic Hospital - Phoenix /ID# 272971 — Phoenix
Providence - St. Jude Medical Center /ID# 271414 — Fullerton
FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 274450 — Oxnard
UCLA - Santa Monica /ID# 271690 — Santa Monica
University Of Colorado - Anschutz Medical Campus /ID# 269069 — Aurora
Rocky Mountain Cancer Centers - Lone Tree /ID# 272603 — Lone Tree
Mayo Clinic Hospital Jacksonville /ID# 275073 — Jacksonville
Mid Florida Hematology And Oncology Center /ID# 273777 — Orange City
… and 19 more centers

China · 15 centers

Cancer Hospital - Chinese Academy of Medical Sciences /ID# 269715 — Beijing
Fujian Province Cancer Hospital /ID# 269150 — Fuzhou
Liuzhou People's hospital /ID# 269667 — Liuzhou
Henan Cancer Hospital /ID# 269668 — Zhengzhou
Union Hospital - Tongji Medical College /ID# 272286 — Wuhan
Hunan Province Cancer Hospital /ID# 269679 — Changsha
Nanjing Drum Tower Hospital /ID# 269762 — Nanjing
The First Affiliated Hospital of Nanchang University /ID# 269190 — Nanchang
… and 7 more centers

Japan · 10 centers

NHO Nagoya Medical Center /ID# 272515 — Nagoya
Aichi Cancer Center /ID# 271978 — Nagoya
Hirosaki University Hospital /ID# 274410 — Hirosaki
Yokohama Municipal Citizen's Hospital /ID# 271979 — Yokohama
Kyoto University Hospital /ID# 272312 — Kyoto
Niigata University Medical and Dental Hospital /ID# 274448 — Niigata
Osaka Medical And Pharmaceutical University Hospital /ID# 273309 — Takatsuki
National Cancer Center Hospital /ID# 273192 — Chuo-Ku
… and 2 more centers

Turkey (Türkiye) · 10 centers