Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT03539536|
Recruitment Status : Recruiting
First Posted : May 29, 2018
Last Update Posted : April 26, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Telisotuzumab vedotin||Phase 2|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||275 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects With Previously Treated c-Met+ Non-Small Cell Lung Cancer|
|Actual Study Start Date :||October 10, 2018|
|Estimated Primary Completion Date :||September 24, 2025|
|Estimated Study Completion Date :||September 24, 2025|
Experimental: Telisotuzumab vedotin
Telisotuzumab vedotin administered via intravenous (IV) infusion every 14 days.
Drug: Telisotuzumab vedotin
Intravenous (IV) infusion
Other Name: ABBV-399
- Overall Response Rate (ORR) (Stage 1 and Stage 2) [ Time Frame: Up to approximately 3 years ]ORR is defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
- Number of Participants with Adverse Events (Alternate dose cohort) [ Time Frame: Up to approximately 3 years ]An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
- Duration of Response (DoR) (Stage 1 and Stage 2) [ Time Frame: Up to approximately 3 years ]DoR is defined as the time from the participant's initial response (CR or PR) to the first occurrence of radiographic progression determined by an independent central review or death from any cause for the responders.
- Disease Control Rate (DCR) (Stage 1 and Stage 2) [ Time Frame: Up to approximately 3 years ]DCR is defined as the percentage of participants with best overall response of confirmed CR, confirmed PR, or stable disease (SD) for at least 12 weeks following enrollment, based on RECIST, version 1.1.
- Progression-Free Survival (PFS) (Stage 1 and Stage 2) [ Time Frame: Up to approximately 3 years ]PFS is defined as the time from the participant's first dose of study drug until the first occurrence of radiographic progression determined by an independent central review or death from any cause.
- Overall Survival (OS) (Stage 1 and Stage 2) [ Time Frame: Up to approximately 3 years ]OS is defined as the time from the participant's first dose of study drug until death from any cause.
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.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Have locally advanced or metastatic non-small cell lung cancer (NSCLC).
- Have 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 prescreening period. Tumor material from the primary tumor site and/or metastatic sites are allowed. If archival tissue is negative for c-Met overexpression, subject can submit fresh biopsy material for reassessment of c-Met expression.
- Histologically documented non-squamous epidermal growth factor receptor (EGFR) wild type NSCLC (site documented EGFR status). Of note, subjects with other actionable mutations are eligible as long as EGFR status is known and all other eligibility criteria are met. As of Protocol Version 11, Stage 1 is complete and Stage 2 is enrolling participants with non-squamous EGFR wild type NSCLC only.
- Must 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.
- Multiple lines of tyrosine kinase inhibitors (TKIs) targeting the same tyrosine kinase (TK) count as 1 line of therapy for the purposes of this eligibility criterion.
- Progressed on systemic cytotoxic therapy (or are ineligible for systemic cytotoxic chemotherapy) and an immune checkpoint inhibitor (as monotherapy or in combination with systemic cytotoxic chemotherapy, or ineligible), and prior anticancer therapies targeting driver gene alterations (if applicable).
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- Treatment with any therapies within the noted time intervals is excluded prior to the first dose of telisotuzumab vedotin as noted in the protocol.
- Metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy) is provided within the protocol.
- Have received radiation therapy to the lungs < 6 months prior to the first dose of telisotuzumab vedotin.
- Have received any live vaccine within 30 days of the first dose of investigational product.
- Has adenosquamous histology.
- Have a history of other malignancies except those noted within the protocol.
- Have a history of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids.
- Have any evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis or ILD within 3 months of the planned first dose of the study drug (Except for Sites in Ireland). For imaging findings deemed clinically insignificant by the treating physician, subject may be eligible after discussion with and approval from the AbbVie medical monitor.
- For Sites in Ireland Only: Must not have any evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis or ILD. For imaging findings deemed clinically insignificant by the treating physician, subject may be eligible after discussion with and approval from the AbbVie medical monitor.
- Have a clinically significant condition(s) as noted in the protocol.
- Have unresolved clinically significant adverse events of Grade >= 2 from prior anticancer therapy, except for alopecia or anemia.
- Have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
For Sites in France and Czech Republic Only: Have the following:
- Known human immunodeficiency virus (HIV) infection. Note: HIV testing is not required for eligibility for this protocol unless mandated by local regulatory authority or ethics committee/institutional review board.
- Active hepatitis B virus (HBV) infection, defined by hepatitis B surface antigen (HBsAg) positivity or HBV DNA >= 500 IU/mL. In participants with known HBV infection, the presence of active infection must be tested locally. If HBV status is unknown, it must be tested locally at screening.
- Active hepatitis C virus (HCV) infection, defined by HCV ribonucleic acid (RNA) positivity. Participants cured of HCV infection may be included in the study. In participants with known HCV infection, the presence of active infection must be tested locally. If HCV status is unknown, it must be tested locally at screening.
- Uncontrolled autoimmune disease.
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): NCT03539536
|Contact: ABBVIE CALL CENTERfirstname.lastname@example.org|
|Study Director:||ABBVIE INC.||AbbVie|
|Other Study ID Numbers:||
2018-001772-38 ( EudraCT Number )
|First Posted:||May 29, 2018 Key Record Dates|
|Last Update Posted:||April 26, 2023|
|Last Verified:||April 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.|
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
|Time Frame:||For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/|
|Access Criteria:||Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Non-small Cell Lung Cancer (NSCLC)
c-Met, c-Met overexpression
MET gene amplification
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases