Non Small Cell Lung Cancer
Conditions
Keywords
c-Met NSCLC, Telisotuzumab Vedotin, ABBV-399, Cancer, Non Small Cell Lung Cancer, NSCLC, MET Amplified NSCLC
Brief summary
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine how telisotuzumab vedotin affects the disease state in adult participants with previously untreated participants with MET amplified non-squamous NSCLC. Change in disease activity will be assessed. Telisotuzumab vedotin is an investigational drug being developed for the treatment of MET amplified non-squamous NSCLC. Participants receive intravenously (IV) infused of telisotuzumab vedotin. Approximately 70 adult participants with previously untreated MET amplified locally advanced/metastatic non-squamous NSCLC will be enrolled in the study in approximately 110 sites worldwide. Participants will receive IV telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Interventions
BIOLOGICALTelisotuzumab Vedotin
Intravenous (IV) Infusion
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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 non-small cell lung cancer (NSCLC) that is locally advanced or metastatic. * Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. * Must have an Eastern Cooperative Oncology Group (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 before subject's first dose of study drug. * Metastases to the central nervous system (CNS) are eligible only after definitive therapy is provided as noted in the protocol. * History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
Exclusion 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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) as Assessed by an Independent Central Review (ICR) | Up to approximately 1.5 years | ORR was 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 as assessed by ICR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) | Up to approximately 1.5 years | DCR was 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 | Up to approximately 1.5 years | PFS was 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) | Up to approximately 1.5 years | OS was defined as the time from participant's first dose of study drug to the event of death from any cause. |
| Duration of Response (DoR) | Up to approximately 1.5 years | DoR was 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. |
| Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32 | The pain in chest item of the EORTC QLQ-LC13 was reported on a 0 to 100 scale, with higher scores representing worse health outcomes with increasing symptom levels or impacts. A negative change from baseline value indicated reduction (i.e. improvement) in symptoms. |
| Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32 | The dyspnea item of the EORTC QLQ-LC13 was reported on a 0 to 100 scale, with higher scores representing worse health outcomes with increasing symptom levels or impacts. A negative change from baseline value indicated reduction (i.e. improvement) in symptoms. |
| 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). | Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32 | The Global Health Status/Quality of Life Domain of the EORTC QLQ-C30 was reported on a scale of 0 to 100, with higher scores indicating better global health status/functioning and a positive change from baseline indicating improvement. |
| Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32 | The cough item of the EORTC QLQ-LC13 was reported on a 0 to 100 scale, with higher scores representing worse health outcomes with increasing symptom levels or impacts. A negative change from baseline value indicated reduction (i.e. improvement) in symptoms. |
Countries
Australia, France, Germany, Israel, Italy, Japan, South Korea, Taiwan, United States
Participant flow
Pre-assignment details
A total of 9 participants were enrolled and received at least 1 dose of study drug.
Participants by arm
| Arm | Count |
|---|---|
| Telisotuzumab Vedotin Participants received telisotuzumab vedotin by IV infusion every 2 weeks until they met study drug discontinuation criteria. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 4 |
| Overall Study | Study terminated by sponsor | 5 |
Baseline characteristics
| Characteristic | Telisotuzumab Vedotin |
|---|---|
| Age, Continuous | 63.4 years STANDARD_DEVIATION 11.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 9 |
| other Total, other adverse events | 9 / 9 |
| serious Total, serious adverse events | 3 / 9 |
Outcome results
Primary
Objective Response Rate (ORR) as Assessed by an Independent Central Review (ICR)
ORR was 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 as assessed by ICR.
Time frame: Up to approximately 1.5 years
Population: The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telisotuzumab Vedotin | Objective Response Rate (ORR) as Assessed by an Independent Central Review (ICR) | 33.3 percentage of participants |
Secondary
Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13)
The cough item of the EORTC QLQ-LC13 was reported on a 0 to 100 scale, with higher scores representing worse health outcomes with increasing symptom levels or impacts. A negative change from baseline value indicated reduction (i.e. improvement) in symptoms.
Time frame: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32
Population: The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluated at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 2 Day 1 | -8.33 score on a scale | Standard Deviation 15.43 |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 3 Day 1 | -11.11 score on a scale | Standard Deviation 34.427 |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 4 Day 1 | -5.56 score on a scale | Standard Deviation 13.608 |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 5 Day 1 | -11.11 score on a scale | Standard Deviation 17.213 |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 6 Day 1 | -13.33 score on a scale | Standard Deviation 29.814 |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 7 Day 1 | -26.67 score on a scale | Standard Deviation 27.889 |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 8 Day 1 | -25.00 score on a scale | Standard Deviation 31.914 |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 9 Day 1 | -6.67 score on a scale | Standard Deviation 14.907 |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 10 Day 1 | -13.33 score on a scale | Standard Deviation 18.257 |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 11 Day 1 | -8.33 score on a scale | Standard Deviation 16.667 |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 12 Day 1 | -16.67 score on a scale | Standard Deviation 23.57 |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 13 Day 1 | -50.00 score on a scale | Standard Deviation 23.57 |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 14 Day 1 | -33.33 score on a scale | — |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 15 Day 1 | -16.67 score on a scale | Standard Deviation 23.57 |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 16 Day 1 | -33.33 score on a scale | Standard Deviation 47.14 |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 17 Day 1 | 0.00 score on a scale | — |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 18 Day 1 | 0.00 score on a scale | — |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 19 Day 1 | -50.00 score on a scale | Standard Deviation 23.57 |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 20 Day 1 | 0.00 score on a scale | — |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 21 Day 1 | -33.33 score on a scale | — |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 22 Day 1 | -50.00 score on a scale | Standard Deviation 23.57 |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 23 Day 1 | -33.33 score on a scale | — |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 24 Day 1 | -33.33 score on a scale | — |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 25 Day 1 | -50.00 score on a scale | Standard Deviation 23.57 |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 26 Day 1 | -33.33 score on a scale | — |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 28 Day 1 | -50.00 score on a scale | Standard Deviation 23.57 |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 30 Day 1 | -33.33 score on a scale | — |
| Telisotuzumab Vedotin | Change From Baseline in Cough as Measured by the Cough Item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) | Cycle 32 Day 1 | -33.33 score on a scale | Standard Deviation 47.14 |
Secondary
Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13
The dyspnea item of the EORTC QLQ-LC13 was reported on a 0 to 100 scale, with higher scores representing worse health outcomes with increasing symptom levels or impacts. A negative change from baseline value indicated reduction (i.e. improvement) in symptoms.
Time frame: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32
Population: The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluated at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 2 Day 1 | -5.56 score on a scale | Standard Deviation 16.798 |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 3 Day 1 | -7.41 score on a scale | Standard Deviation 11.476 |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 4 Day 1 | 1.85 score on a scale | Standard Deviation 4.536 |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 5 Day 1 | 7.41 score on a scale | Standard Deviation 9.072 |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 6 Day 1 | 2.22 score on a scale | Standard Deviation 4.969 |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 7 Day 1 | -2.22 score on a scale | Standard Deviation 12.172 |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 8 Day 1 | -0.00 score on a scale | Standard Deviation 9.072 |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 9 Day 1 | 4.44 score on a scale | Standard Deviation 6.086 |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 10 Day 1 | -2.22 score on a scale | Standard Deviation 12.172 |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 11 Day 1 | -2.78 score on a scale | Standard Deviation 13.981 |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 12 Day 1 | 5.56 score on a scale | Standard Deviation 7.857 |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 13 Day 1 | -5.56 score on a scale | Standard Deviation 23.57 |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 14 Day 1 | 11.11 score on a scale | — |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 15 Day 1 | 0.00 score on a scale | Standard Deviation 0 |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 16 Day 1 | -11.11 score on a scale | Standard Deviation 15.713 |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 17 Day 1 | 0.00 score on a scale | — |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 18 Day 1 | 11.11 score on a scale | — |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 19 Day 1 | -0.00 score on a scale | Standard Deviation 15.713 |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 20 Day 1 | 11.11 score on a scale | — |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 21 Day 1 | 11.11 score on a scale | — |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 22 Day 1 | -5.56 score on a scale | Standard Deviation 23.57 |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 23 Day 1 | 0.00 score on a scale | — |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 24 Day 1 | 0.00 score on a scale | — |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 25 Day 1 | 5.56 score on a scale | Standard Deviation 7.857 |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 26 Day 1 | 0.00 score on a scale | — |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 28 Day 1 | -0.00 score on a scale | Standard Deviation 15.713 |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 30 Day 1 | 11.11 score on a scale | — |
| Telisotuzumab Vedotin | Change From Baseline in Dyspnea as Measured by the Dyspnea Item of the EORTC QLQ-LC13 | Cycle 32 Day 1 | -0.00 score on a scale | Standard Deviation 15.713 |
Secondary
Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13
The pain in chest item of the EORTC QLQ-LC13 was reported on a 0 to 100 scale, with higher scores representing worse health outcomes with increasing symptom levels or impacts. A negative change from baseline value indicated reduction (i.e. improvement) in symptoms.
Time frame: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32
Population: The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluated at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 18 Day 1 | 0.00 score on a scale | — |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 19 Day 1 | 0.00 score on a scale | Standard Deviation 0 |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 20 Day 1 | 0.00 score on a scale | — |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 21 Day 1 | 0.00 score on a scale | — |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 22 Day 1 | 0.00 score on a scale | Standard Deviation 0 |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 23 Day 1 | 0.00 score on a scale | — |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 24 Day 1 | 0.00 score on a scale | — |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 25 Day 1 | -16.67 score on a scale | Standard Deviation 23.57 |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 26 Day 1 | 0.00 score on a scale | — |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 28 Day 1 | 0.00 score on a scale | Standard Deviation 0 |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 30 Day 1 | 0.00 score on a scale | — |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 32 Day 1 | 0.00 score on a scale | Standard Deviation 0 |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 2 Day 1 | 4.17 score on a scale | Standard Deviation 27.817 |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 3 Day 1 | -5.56 score on a scale | Standard Deviation 13.608 |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 4 Day 1 | 5.56 score on a scale | Standard Deviation 13.608 |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 5 Day 1 | 16.67 score on a scale | Standard Deviation 40.825 |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 6 Day 1 | 0.00 score on a scale | Standard Deviation 0 |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 7 Day 1 | -6.67 score on a scale | Standard Deviation 14.907 |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 8 Day 1 | 0.00 score on a scale | Standard Deviation 0 |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 9 Day 1 | 0.00 score on a scale | Standard Deviation 0 |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 10 Day 1 | 0.00 score on a scale | Standard Deviation 23.57 |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 11 Day 1 | 8.33 score on a scale | Standard Deviation 16.667 |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 12 Day 1 | 0.00 score on a scale | Standard Deviation 0 |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 13 Day 1 | -16.67 score on a scale | Standard Deviation 23.57 |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 14 Day 1 | 0.00 score on a scale | — |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 15 Day 1 | 0.00 score on a scale | Standard Deviation 0 |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 16 Day 1 | 0.00 score on a scale | Standard Deviation 0 |
| Telisotuzumab Vedotin | Change From Baseline in Pain as Measured by the Pain in Chest Item of the EORTC QLQ-LC13 | Cycle 17 Day 1 | 0.00 score on a scale | — |
Secondary
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).
The Global Health Status/Quality of Life Domain of the EORTC QLQ-C30 was reported on a scale of 0 to 100, with higher scores indicating better global health status/functioning and a positive change from baseline indicating improvement.
Time frame: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 28, 30, 32
Population: The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluated at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telisotuzumab Vedotin | 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). | Cycle 3 Day 1 | 2.78 score on a scale | Standard Deviation 12.546 |
| Telisotuzumab Vedotin | 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). | Cycle 4 Day 1 | -2.78 score on a scale | Standard Deviation 8.607 |
| Telisotuzumab Vedotin | 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). | Cycle 5 Day 1 | -4.17 score on a scale | Standard Deviation 14.672 |
| Telisotuzumab Vedotin | 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). | Cycle 6 Day 1 | 1.67 score on a scale | Standard Deviation 12.36 |
| Telisotuzumab Vedotin | 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). | Cycle 7 Day 1 | 3.33 score on a scale | Standard Deviation 7.454 |
| Telisotuzumab Vedotin | 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). | Cycle 8 Day 1 | 4.17 score on a scale | Standard Deviation 8.333 |
| Telisotuzumab Vedotin | 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). | Cycle 9 Day 1 | -3.33 score on a scale | Standard Deviation 18.257 |
| Telisotuzumab Vedotin | 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). | Cycle 2 Day 1 | 3.13 score on a scale | Standard Deviation 14.042 |
| Telisotuzumab Vedotin | 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). | Cycle 10 Day 1 | 3.33 score on a scale | Standard Deviation 7.454 |
| Telisotuzumab Vedotin | 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). | Cycle 11 Day 1 | -4.17 score on a scale | Standard Deviation 8.333 |
| Telisotuzumab Vedotin | 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). | Cycle 12 Day 1 | 8.33 score on a scale | Standard Deviation 11.785 |
| Telisotuzumab Vedotin | 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). | Cycle 13 Day 1 | 8.33 score on a scale | Standard Deviation 11.785 |
| Telisotuzumab Vedotin | 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). | Cycle 14 Day 1 | 16.67 score on a scale | — |
| Telisotuzumab Vedotin | 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). | Cycle 15 Day 1 | 8.33 score on a scale | Standard Deviation 11.785 |
| Telisotuzumab Vedotin | 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). | Cycle 16 Day 1 | 4.17 score on a scale | Standard Deviation 5.893 |
| Telisotuzumab Vedotin | 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). | Cycle 17 Day 1 | 0.00 score on a scale | — |
| Telisotuzumab Vedotin | 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). | Cycle 18 Day 1 | 0.00 score on a scale | — |
| Telisotuzumab Vedotin | 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). | Cycle 19 Day 1 | -8.33 score on a scale | Standard Deviation 11.785 |
| Telisotuzumab Vedotin | 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). | Cycle 20 Day 1 | 0.00 score on a scale | — |
| Telisotuzumab Vedotin | 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). | Cycle 21 Day 1 | 0.00 score on a scale | — |
| Telisotuzumab Vedotin | 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). | Cycle 22 Day 1 | -4.17 score on a scale | Standard Deviation 5.893 |
| Telisotuzumab Vedotin | 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). | Cycle 23 Day 1 | -16.67 score on a scale | — |
| Telisotuzumab Vedotin | 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). | Cycle 24 Day 1 | 16.67 score on a scale | — |
| Telisotuzumab Vedotin | 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). | Cycle 25 Day 1 | 8.33 score on a scale | Standard Deviation 11.785 |
| Telisotuzumab Vedotin | 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). | Cycle 26 Day 1 | 0.00 score on a scale | — |
| Telisotuzumab Vedotin | 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). | Cycle 28 Day 1 | -8.33 score on a scale | Standard Deviation 11.785 |
| Telisotuzumab Vedotin | 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). | Cycle 30 Day 1 | 16.67 score on a scale | — |
| Telisotuzumab Vedotin | 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). | Cycle 32 Day 1 | -16.67 score on a scale | Standard Deviation 23.57 |
Secondary
Disease Control Rate (DCR)
DCR was 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.
Time frame: Up to approximately 1.5 years
Population: The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telisotuzumab Vedotin | Disease Control Rate (DCR) | 44.4 percentage of participants |
Secondary
Duration of Response (DoR)
DoR was 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.
Time frame: Up to approximately 1.5 years
Population: The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug. Here, Overall number of participants analyzed represents participants evaluable for this outcome measure with CR or PR.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Telisotuzumab Vedotin | Duration of Response (DoR) | 8.5 months |
Secondary
Overall Survival (OS)
OS was defined as the time from participant's first dose of study drug to the event of death from any cause.
Time frame: Up to approximately 1.5 years
Population: The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Telisotuzumab Vedotin | Overall Survival (OS) | 17.5 months |
Secondary
Progression Free Survival (PFS) Per ICR
PFS was 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.
Time frame: Up to approximately 1.5 years
Population: The efficacy evaluable analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Telisotuzumab Vedotin | Progression Free Survival (PFS) Per ICR | 4.0 months |