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)

JRCT ID: jRCT2031220629

Registered date:09/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non small cell lung cancer
• Date of first enrollment: 19/01/2023
• Target sample size: 70
• Countries of recruitment: United states,Japan,Australia,Japan,France,Japan,Germany,Japan,Israel,Japan,Italy,Japan,Korea,Japan,Taiwan,Japan
• Study type: Interventional
• Intervention(s): Participants will receive IV telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.

Outcome(s)

Primary Outcome

- Objective response rate (ORR) as Assessed by an Independent Central Review (ICR) :Time Frame: Up to 1 Year
ORR will be 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.

Secondary Outcome

- Duration of Response (DoR):Time Frame: Up to 1 Year
DoR will be defined for confirmed responders as the time from the initial response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1, or death from any cause.

- Disease Control Rate (DCR):Time Frame: Up to 1 Year
DCR will be defined as the percentage of participants with best overall response of confirmed CR or confirmed PR, or stable disease (SD) for at least 12 weeks following first dose of study drug, based on RECIST, version 1.1.

- Progression Free Survival (PFS) per ICR:Time Frame: Up to 1 Year
PFS will be defined as the time from the participant's first dose of study drug to the first occurrence of radiographic progression based on RECIST, version 1.1 or death from any cause.

- Overall Survival (OS):Time Frame: Up to 2 Years
OS will be defined as the time from participant's first dose of study drug to the event of death from any cause.

- Time to Deterioration in Cough:Time Frame: Up to 1 Year
Time to deterioration in cough as measured by the cough items of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13).

- Time to Deterioration in Pain:Time Frame: Up to 1 Year
Time to deterioration in pain as measured by the cough items of the EORTC QLQ-LC13.

- Time to Deterioration in Dyspnea:Time Frame: Up to 1 Year
Time to deterioration in dyspnea as measured by the cough items of the EORTC QLQ-LC13.

- Time to Deterioration of Physical Functioning:Time Frame: Up to 1 Year
Time to deterioration of physical functioning as measured by the physical functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30).

- Change from Baseline in Quality of Life as measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).:Time Frame: Up to 1 Year

The EORTC QLQ-C30 assesses health-related quality of life in cancer patients participating in clinical trials. The EORTC QLQ-C30 comprises 5 functional scales (physical, role, emotional, social, cognitive), 8 single-item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, and dyspnea), as well as subscales assessing global health/quality of life and financial impact. Raw scores are transformed to a scale of 0 to 100, with higher scores representing better functioning/quality of life and greater symptom burden.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- 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.
- Must have histologically documented non-squamous adenocarcinoma NSCLC that is locally advanced or metastatic.
- Must have measurable disease per RECIST version 1.1.
- Must have an ECOG Performance Status of 0 or 1.
- Participant 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 or more before subjects's first dose of study drug.
- Metastases to the CNS are eligible only after definitive therapy is provided as noted in the protocol.
- History of radiation pneumonitis in the radiation field is permitted.

Exclude criteria

- Alterations in EGFR, ALK, ROS1, or BRAF that predict sensitivity to available targeted therapy. Participants with other alterations that are candidates for available targeted therapy.
- Prior systemic therapy for locally advanced/metastatic NSCLC. Of note, 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.
- Have a history of other malignancies except those noted in the protocol.
- 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.
- Received prior c-Met-targeted antibodies.
- Have NSCLC that is eligible for treatment with curative intent.
- Have unresolved adverse events(AEs) Grade 2 or higher from prior anticancer therapy, except for alopecia or anemia.
- Have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
- Have clinically significant condition(s) as noted in the protocol.

Related Information

• Primary Sponsor: Yajima Yoko
• Secondary ID(s): NCT05513703