Clinical trial NCT06772623: A Study to Evaluate the Adverse Events, Efficacy, and Optimal Dose of Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Budigalimab in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations
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 Budigalimab in Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Non Small Cell Lung Carcinoma
Keywords: Non Small Cell Lung Carcinoma
Pembrolizumab
Pemetrexed
Carboplatin
Cisplatin
Telisotuzumab Adizutecan
ABBV-400
ABBV-181
Budigalimab
AndroMETa-Lung-536
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-01-13
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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) inhibitor (budigalimab) to adult participants to treat NSCLC.

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 ABBV-400 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 4 treatment groups. Two groups will receive budigalimab with different optimized doses of telisotuzumab adizutecan (to allow for the best dose to be studied in the future). One group will receive budigalimab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by budigalimab and pemetrexed. 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 172 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 budigalimab or receive IV budigalimab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by budigalimab and pemetrexed, 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.


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.
* 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.

Primary outcomes:
measure: Part 1: Dose-Limiting Toxicities (DLT)s of Telisotuzumab Adizutecan
timeFrame: Up to Approximately 84 Days
measure: Part 2: Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to Approximately 33 Months
measure: Number of Participants with Adverse Events (AE)s
timeFrame: Up to Approximately 33 Months
Secondary outcomes:
measure: Part 2: Progression Free Survival (PFS) as Assessed by BICR
timeFrame: Up to Approximately 33 Months
measure: Part 2: Duration of Response (DOR) by BICR
timeFrame: Up to Approximately 33 Months
measure: Part 2: Disease Control (DC) as Assessed by BICR
timeFrame: Up to Approximately 33 Months
measure: Part 1 and Part 2: OR as Assessed by Investigator
timeFrame: Up to Approximately 33 Months
measure: Part 1 and Part 2: PFS as Assessed by Investigator
timeFrame: Up to Approximately 33 Months
measure: Part 1 and Part 2: DOR as Assessed by Investigator
timeFrame: Up to Approximately 33 Months
measure: Part 1 and Part 2: DC as Assessed by Investigator
timeFrame: Up to Approximately 33 Months
measure: Part 1 and Part 2: Overall Survival (OS)
timeFrame: Up to Approximately 33 Months
measure: Programmed Death Ligand 1 (PD-L1) Subgroups: OR
timeFrame: Up to Approximately 33 Months
measure: PD-L1 Subgroups: PFS
timeFrame: Up to Approximately 33 Months
measure: PD-L1 Subgroups: OS
timeFrame: Up to Approximately 33 Months
measure: PD-L1 Subgroups: DOR
timeFrame: Up to Approximately 33 Months
measure: PD-L1 Subgroups: DC
timeFrame: Up to Approximately 33 Months
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Providence - St. Jude Medical Center /ID# 271414
state: California
city: Oxnard
country: United States
facility: FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 274450
state: California
city: Lone Tree
country: United States
facility: Rocky Mountain Cancer Centers - Lone Tree /ID# 272603
state: Colorado
city: Orange City
country: United States
facility: Mid Florida Hematology And Oncology Center /ID# 273777
state: Florida
city: Hinsdale
country: United States
facility: Hope And Healing Cancer Services /ID# 276223
state: Illinois
city: East Brunswick
country: United States
facility: Astera Cancer Care /ID# 271915
state: New Jersey
city: New York
country: United States
facility: New York Cancer and Blood Specialists - New York /ID# 272547
state: New York
city: Columbus
country: United States
facility: The Mark H Zangmeister Center /ID# 272502
state: Ohio
city: Houston
country: United States
facility: Millennium Research & Clinical Development /ID# 271717
state: Texas
city: Tacoma
country: United States
facility: Northwest Medical Specialties Tacoma /ID# 270469
state: Washington
city: Saint-Herblain
country: France
facility: CHU Nantes - Hopital Laennec /ID# 268475
state: Loire-Atlantique
city: Nice
country: France
facility: Centre Antoine-Lacassagne /ID# 268486
state: Provence-Alpes-Cote-d Azur
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy /ID# 258373
state: Val-de-Marne
city: Koeln
country: Germany
facility: Universitaetsklinikum Koeln /ID# 268489
state: Nordrhein-Westfalen
city: Meldola
country: Italy
facility: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 268684
state: Reggio Emilia
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center /ID# 271978
state: Aichi
city: Yokohama-shi
country: Japan
facility: Yokohama Municipal Citizen's Hospital /ID# 271979
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: Kyoto University Hospital /ID# 272312
state: Kyoto
city: Takatsuki
country: Japan
facility: Osaka Medical And Pharmaceutical University Hospital /ID# 273309
state: Osaka
city: Chuo-Ku
country: Japan
facility: National Cancer Center Hospital /ID# 273192
state: Tokyo
city: Rio Piedras
country: Puerto Rico
facility: Pan American Center for Oncology Trials /ID# 268827
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña /ID# 271456
state: A Coruna
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria /ID# 271312
state: Malaga
city: Seville
country: Spain
facility: Hospital Universitario Virgen Macarena /ID# 271447
state: Sevilla
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante Doctor Balmis /ID# 271316
city: Barcelona
country: Spain
facility: Parc de Salut Mar - Hospital del Mar /ID# 271310
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona /ID# 271452
city: Chia-Yi
country: Taiwan
facility: Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 268789
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital /ID# 268138
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital /ID# 268787
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital /ID# 268137
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: