Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer

  • STATUS
    Recruiting
  • End date
    Jan 16, 2025
  • participants needed
    233
  • sponsor
    AbbVie
Updated on 21 September 2021
tyrosine
systemic therapy
growth factor
epidermal growth factor receptor
EGFR
cancer treatment
c-MET
cancer chemotherapy
epidermal growth factor
stage iv non-small cell lung cancer
lung carcinoma

Summary

This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that over express c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate efficacy in the selected population(s) (Stage 2).

Details
Condition Non-Small Cell Lung Cancer, nsclc
Treatment Telisotuzumab vedotin
Clinical Study IdentifierNCT03539536
SponsorAbbVie
Last Modified on21 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically confirmed non-squamous cell non-small cell lung cancer (NSCLC) with known epidermal growth factor receptor (EGFR) status (wild type or mutant; with site documented status). Of note, participants with other actionable mutations are eligible as long as EGFR status is known and all other eligibility criteria are met
Has locally advanced or metastatic NSCLC
Has c-Met+ NSCLC as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory. Participant must submit archival or fresh tumor material for assessment of c-Met levels during the pre-screening period. If archival tissue is c-Met negative, participant can submit fresh biopsy material for reassessment of c-Met expression
Have received no more than 2 lines of prior systemic therapy (including no more than 1 line of systemic cytotoxic chemotherapy) in the locally advanced or metastatic setting
Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
Multiple lines of tyrosine kinase inhibitors (TKIs) targeting the same gene alteration count as 1 line of therapy for the purposes of this eligibility criterion

Exclusion Criteria

Have received prior c-Met-targeted antibody-based therapies
Has adenosquamous histology
Participants with metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy)
Has a clinically significant condition(s) described in the protocol
Has unresolved clinically significant adverse events >= grade 2 from prior anticancer therapy, except for alopecia or anemia
Had major surgery within 21 days prior to the first dose of telisotuzumab vedotin
Has received live vaccine within 30 days of the first dose of telisotuzumab vedotin
Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
History of interstitial lung disease or pneumonitis that required treatment with systemic steroids, or any evidence of active interstitial lung disease or pneumonitis
Participants do not have any evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis or interstitial lung disease within 3 months of the planned first dose of the study drug
Participants must not have received radiation therapy to the lung <6 months prior to the first dose of telisotuzumab vedotin
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note