Study of Intravenous Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Diseases [C] - Neoplasms [C04]

Trial duration

23 Apr 2025 → ongoing

Decision date (initial)

2025-04-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AbbVie Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Safety, Pharmacokinetic, Efficacy

To evaluate the safety, tolerability, efficacy and optimal recommended Phase 3 dose (RP3D) of telisotuzumab adizutecan in combination with a PD-1 immune checkpoint inhibitor (budigalimab [Part 1] or pembrolizumab [Part 2])

Secondary objectives 2

1. To evaluate clinical outcomes (PFS, DOR, OS, and DCR) of telisotuzumab adizutecan in combination with a PD-1 immune checkpoint inhibitor.
2. To characterize the pharmacokinetics (PK) and immunogenicity of telisotuzumab adizutecan in combination with PD-1 immune checkpoint inhibitor.

Conditions and MedDRA coding

Advanced or Metastatic Non-Squamous NSCLC

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Subject must have had no prior systemic therapy for locally advanced or metastatic NSCLC including PD-L1/PD-L2 inhibitor, CTLA-4 inhibitor, TIM 3 inhibitors, or any other immunotherapy Subject may have received prior adjuvant/neoadjuvant systemic therapy and/or radiation as defined in protocol (Allowed for 1L pts), in both parts.
2. Subject must have received 1 line of prior systemic therapy in the locally advanced or metastatic setting (Neoadjuvant and adjuvant systemic therapy would count as a prior line). Eligibility for subjects with or without actionable gene alterations will be defined in protocol (Allowed for 2L pts), on part 1 only.

Exclusion criteria 3

1. For 1L subjects in Part 1 and 2: Subjects with EGFR or other genomic aberration (e.g., ALK, ROS1, KRAS G12C, BRAFV600E, NTRK1,2,3, RET1, HER-2, MET exon 14 skipping, etc.) for which a locally approved targeted therapy is available for first-line treatment.
2. Subject with prior treatment of a c-Met targeting antibody (e.g., ABBV-400, ABBV-399 or topoisomerase-inhibitor containing regimen. Prior treatment with MET tyrosine kinase inhibitors is allowed.
3. 3. Subject with known uncontrolled metastases to the CNS.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Part 1: dose-limiting toxicity.
2. Part 2: efficacy endpoint is the OR as assessed by BICR (as confirmed CR or PR based on RECIST v1.1).

Secondary endpoints 5

1. Progression Free Survival (PFS): the time from the subject's randomization date to the first occurrence of radiographic progression per BICR based on RECIST v1.1 or death from any cause, whichever occurs earlier.
2. Duration Of Response (DOR): the time from the first documented CR or PR per BICR to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause, whichever occurs first.
3. Disease Control: best overall response of confirmed CR or confirmed PR, or SD for at least 11 weeks following randomization date based on RECIST v1.1, by the BICR. OR, PFS, DOR, and DC by investigator per RECIST v1.1.
4. Overall Survival: the time from subject's randomization date (Part 2) or first dose date of study treatment (Part 1) to the event of death from any cause. Subjects with no documented death will be censored at the last known alive date.
5. OR, PFS, OS, DOR, and DC in PD-L1 and c-Met subgroups.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Third parties 9

Locations

7 EU/EEA countries · 49 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 69 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications