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

AbbVie

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Non Small Cell Lung Carcinoma

Treatments: Drug: Carboplatin; Drug: Pembrolizumab; Drug: Cisplatin; Drug: Telisotuzumab Adizutecan; Drug: Budigalimab; Drug: Pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT06772623

M24-536

2024-514465-18 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 172 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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172 participants in 5 patient groups

Part 1: Telisotuzumab Adizutecan + Budigalimab

Experimental group

Description:

Participants will receive several doses of telisotuzumab adizutecan in combination with budigalimab, as part of the 33 month study duration.

Treatment:

Drug: Budigalimab

Drug: Telisotuzumab Adizutecan

Part 2 Arm 1: Telisotuzumab Adizutecan + Budigalimab Dose A

Experimental group

Description:

Participants will receive telisotuzumab adizutecan dose A in combination with budigalimab, as part of the 33 month study duration.

Treatment:

Drug: Budigalimab

Drug: Telisotuzumab Adizutecan

Part 2 Arm 2: Telisotuzumab Adizutecan + Budigalimab Dose B

Experimental group

Description:

Participants will receive telisotuzumab adizutecan dose B in combination with budigalimab, as part of the 33 month study duration.

Treatment:

Drug: Budigalimab

Drug: Telisotuzumab Adizutecan

Part 2 Arm 3: Budigalimab +

Experimental group

Description:

Participants will receive budigalimab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by budigalimab and pemetrexed, as part of the 33 month study duration.

Treatment:

Drug: Pemetrexed

Drug: Budigalimab

Drug: Cisplatin

Drug: Carboplatin

Part 2: Standard of Care

Experimental group

Description:

Participants will receive pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed, as part of the 33 month study duration.

Treatment:

Drug: Pemetrexed

Drug: Cisplatin

Drug: Pembrolizumab

Drug: Pembrolizumab

Drug: Carboplatin