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Expanded Access to Telisotuzumab Vedotin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04830202
Expanded Access Status : Available
First Posted : April 5, 2021
Last Update Posted : January 6, 2023
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Telisotuzumab vedotin prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Condition or disease Intervention/treatment
Non-Small Cell Lung Cancer (NSCLC) Drug: Telisotuzumab vedotin

Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Expanded Access to Telisotuzumab Vedotin

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: Telisotuzumab vedotin
    Intravenous Infusion
    Other Name: ABBV-399
Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- The participant must not be eligible for a telisotuzumab vedotin clinical trial.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04830202


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04830202    
Other Study ID Numbers: C20-503
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: January 6, 2023
Last Verified: February 2022
Keywords provided by AbbVie:
Non-Small Cell Lung Cancer (NSCLC)
Telisotuzumab vedotin
ABBV-399
Expanded Access
Pre-approval Access
 Compassionate Use
Special Access Program
Named Patient Basis
Special Access Scheme
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms