A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants with Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (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

Diseases [C] - Neoplasms [C04]

Trial duration

6 Apr 2023 → 29 Oct 2024

Decision date (initial)

2023-02-06

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

AbbVie Inc.

External identifiers

EU CT number

2022-500608-23-00

ClinicalTrials.gov

NCT05513703

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

To determine objective response rate (ORR) of telisotuzumab vedotin in previously untreated subjects with MET amplified non-squamous NSCLC.

Secondary objectives 8

1. Determine duration of response (DoR)
2. Determine disease control rate (DCR)
3. Determine progression-free survival (PFS)
4. Determine Overall Survival (OS)
5. Determine time to deterioration in cough or pain or dyspnea as measured respectively by the cough, pain, and dyspnea items of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
6. Determine time to deterioration of physical functioning as measured by the physical functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30)
7. Determine change from baseline in quality of life as measured by the global health status/quality of life domain of the EORTC QLQ-C30
8. Determine safety and tolerability

Conditions and MedDRA coding

Previously Untreated MET Amplified Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-670856-PIP03-31

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.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Subjects must have completed an informed consent.
2. Subject must be an adult, at least 18 years old.
3. Subject must have MET amplification in tumor tissue as determined by the Sponsor-designated central laboratory MET FISH Assay or in plasma and/or tissue by a Sponsor-approved assay. Where confirmed as a local requirement, the central assay can only be utilized after IVDR certification is obtained.
4. Subject must have histologically documented non-squamous adenocarcinoma NSCLC that is locally advanced or metastatic.
5. Subject must have measurable disease per RECIST version 1.1.
6. Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
7. Subjects with metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy) is provided and: 1) There is no evidence of progression of CNS metastases at least 2 weeks after definitive therapy. 2) They are asymptomatic and off or on a stable or reducing dose of systemic steroids and/or anticonvulsants for at least 2 weeks prior to first dose of telisotuzumab vedotin.
8. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.

Exclusion criteria 9

1. Subject must not have clinically significant condition(s) including but not limited to the following: 1) Clinically significant vascular disease, including: Myocardial infarction within 1 year or stroke within 6 months prior to first dose of study drug, or unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III – IV), cardiac arrhythmia (CTCAE Version 5 Grade 2 or higher), or clinically significant electrocardiogram (ECG) abnormalities. 2) Clinically significant liver disease, including hepatitis, current alcohol abuse, or cirrhosis. 3) Grade ≥ 2 edema or lymphedema. 4) Grade ≥ 2 ascites or pleural effusion. 5) Grade ≥ 2 neuropathy. 6) Active uncontrolled bacterial or viral infection.
2. Subjects with alterations in EGFR, ALK, ROS1, or BRAF that predict sensitivity to available targeted therapy are not eligible. Subjects with other alterations that are candidates for available targeted therapy are not eligible.
3. Subject must have no prior systemic therapy for locally advanced/metastatic NSCLC. Limited treatment with no more than 1 cycle of chemotherapy is allowed prior to receiving the first dose of study drug provided there is no evidence of progression. Subject may have received prior adjuvant/neoadjuvant systemic chemotherapy and/or radiation and/or immunotherapy provided that the subject has not progressed on or within 6 months of completing the regimen and it was completed ≥ 6 months before subject's first dose of study drug.
4. Subject must not have received prior c-Met-targeted antibodies.
5. Subject must not have NSCLC that is eligible for treatment with curative intent.
6. Subjects must not have a history of other malignancies except: 1) Malignancy treated with curative intent and with no known active disease present for ≥ 2 years before the first dose of study drug and felt to be at low risk for recurrence by investigator. 2) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. 3) Adequately treated carcinoma in situ without current evidence of disease.
7. Subject must not have a history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
8. Subject must not have unresolved adverse events (AEs) ≥ Grade 2 from prior anticancer therapy, except for alopecia or anemia.
9. Subject must not have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Objective response rate (ORR) assessed by an independent central review (ICR).

Secondary endpoints 7

1. Duration of Response (DoR)
2. Disease control rate (DCR)
3. Progression Free Survival (PFS) per ICR
4. Overall Survival (OS)
5. Time to deterioration in cough or pain or dyspnea as measured respectively by the cough, pain, and dyspnea items of the European Organization Lung Cancer Module 13 (EORTC QLQ-LC13).
6. Time to deterioration of physical functioning as measured by the physical functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30).
7. Change from baseline in quality of life as measured by the global health status/quality of life domain of the EORTC QLQ-C30.

Investigational products

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

Test 1

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

5 EU/EEA countries · 20 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 36 files

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

Application history

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