A Study of SGN-B6A Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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This clinical trial is studying non-small cell lung cancer (NSCLC). Participants in this study must have cancer that has spread through their body or can't be removed with surgery. Participants in this study must have been treated with no more than a platinum-based chemotherapy and an anti-PD-(L)1 drug. Participants with tumors that have certain treatable genomic alterations must have had no more than 2 drugs for that genomic alteration, in addition to platinum-based chemotherapy. This clinical trial uses an experimental drug called SGN-B6A, which is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. This clinical trial also uses a drug called docetaxel. Docetaxel is an anticancer drug that has been approved to treat non-small cell lung cancer. It is usually given to patients who previously received another anticancer treatment. In this study, one group of participants will get SGN-B6A on Days 1 and 8 during each 21-day-cycle. A second group of participants will get docetaxel on Day 1 during each 21-day cycle. This study is being done to see if SGN-B6A works better than docetaxel to treat participants with NSCLC. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease.

Official Title
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A Randomized, Phase 3, Open-label Study to Evaluate SGN-B6A Compared With Docetaxel in Adult Subjects With Previously Treated Non-small Cell Lung Cancer

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: SGN-B6A
* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed diagnosis of Stage IIIB, IIIC, or Stage IV (M1a, M1b, or M1c) NSCLC Subjects who have NSCLC with known actionable genomic alteration (AGAs) are permitted Participants must only have received the following prior therapies in the locally advanced recurrent or metastatic setting: Participants without AGAs must have received prior treatment with platinum-based chemotherapy and a PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy), unless contraindicated. Participants with AGAs must have received no more than 2 applicable targeted therapies and must have received prior treatment with platinum-based chemotherapy. May also have received up to one PD(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy). Measurable disease based on RECIST v1.1 Eastern cooperative Oncology Group (ECOG) performance status score of 0 or 1 Exclusion Criteria: Life expectancy of less than (<) 3 months Known allergies/hypersensitivity/intolerance to or contraindication of taxanes, docetaxel, or any excipient contained in the drug formulation of SGN-B6A History of another malignancy within 3 years before Cycle 1 Day 1, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death Participants with any of the following respiratory conditions: Evidence of noninfectious interstitial lung disease (ILD) or pneumonitis that: Was previous diagnosed and required systemic steroids, or Is currently diagnosed and managed, or Is suspected on radiologic imaging at screening Known diffusing capacity of the lung for carbon monoxide (DLCO) < 50% Any Grade greater than or equal to (≥) 3 pulmonary disease unrelated to underlying malignancy Pre-existing peripheral neuropathy Grade greater than or equal to (≥) 2 Uncontrolled diabetes mellitus Prior therapy: Any prior treatment with docetaxel or MMAE-derived drugs At least 14 days must have elapsed from the last dose of radiotherapy until Cycle 1 Day 1. Prior radiation therapy to the lung parenchyma that is >30 Gray (Gy) within 6 months of Cycle 1 Day 1. Any systemic anticancer therapy (standard or experimental) within 21 days prior to Cycle 1 Day 1. Active central nervous system (CNS) lesions, including leptomeningeal metastasis, are excluded. Participants with definitively treated brain metastases are eligible in they meet the following criteria: Have been clinically stable for at least 4 weeks prior to treatment initiation and baseline scans show no evidence of new or enlarged metastasis On a stable dose of less than or equal to (≤) 10mg/day of prednisone or equivalent for a least 2 weeks (if requiring steroid treatment) Treatment with corticosteroids greater than (>) 1 month prior to Screening visit No evidence of clinical and radiographic disease progression in the CNS for ≥ 21 days after definitive radiotherapy and/or surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Arm<br>SGN-B6A monotherapy | Drug: SGN-B6A<br>* Given into the vein (IV; intravenously) on Day 1 and 8 of a 21-day cycle<br>|
| Active Comparator: Control Arm<br>Docetaxel monotherapy | Drug: docetaxel<br>* 75 mg/m^2 given into the vein (IV; intravenously) on Day 1 of a 21-day cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | The time from date of randomization to date of death due to any cause. | Approximately 5 years | 
| Confirmed Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as assessed by Blinded Independent Central Review (BICR) | The proportion of subjects with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1. | Approximately 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) per RECIST v1.1 by BICR | The time from date of randomization to the first documented disease progression per RECIST v1.1 or to death due to any cause. | Approximately 5 years | 
| Confirmed ORR per RECIST v1.1 by investigator assessment | The proportion of subjects with confirmed CR or PR according to RECIST v1.1. | Approximately 5 years | 
| PFS per RECIST v1.1 by investigator assessment | The time from date of randomization to the first documented disease progression per RECIST v1.1 or to death due to any cause. | Approximately 5 years | 
| Duration of Response (DOR) per RECIST v1.1 by BICR | The time from the first documented objective response (CR or PR that is subsequently confirmed) to the first documented disease progression per RECIST v1.1 or to death due to any cause. | Approximately 5 years | 
| DOR per RECIST v1.1 by investigator assessment | The time from the first documented objective response (CR or PR that is subsequently confirmed) to the first documented disease progression per RECIST v1.1 or to death due to any cause. | Approximately 5 years | 
| Number of participants with adverse events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Through 30 days after the last study intervention; Approximately 5 years | 
| Mean score in the global health status/QoL combined score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) | The EORTC QLQ-C30 was developed as a quantitative measure of health-related quality of life (HRQoL). Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. | Approximately 5 years | 
| Change from baseline in global health status/QoL combined score on the EORTC QLQ-C30 | The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. | Approximately 5 years | 
| Mean score in physical functioning scores on the EORTC QLQ-C30 | The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. | Approximately 5 years | 
| Change from baseline score in physical functioning scores on the EORTC QLQ-C30 | The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. | Approximately 5 years | 
| Mean score in role functioning scores on the EORTC QLQ-C30 | The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. | Approximately 5 years | 
| Change from baseline score in role functioning scores on the EORTC QLQ-C30 | The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. | Approximately 5 years | 
| Mean scores in the dyspnea, cough, and chest pain scores on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) | The EORTC QLQ-LC13 is a lung-cancer specific module that serves as an additional 13 item questionnaire to the general EORTC cancer questionnaire. It incorporates 1 multi-item scale to assess dyspnea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Scores range from 0 to 100. A high score for a symptom scale/item represents a high level of symptomatology/problems. | Approximately 5 years | 
| Change from baseline in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13 | The EORTC QLQ-LC13 is a lung-cancer specific module that serves as an additional 13 item questionnaire to the general EORTC cancer questionnaire. It incorporates 1 multi-item scale to assess dyspnea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Scores range from 0 to 100. A high score for a symptom scale/item represents a high level of symptomatology/problems. | Approximately 5 years | 
| Time to Deterioration (TTD) in the global health status/QoL combined score on the EORTC QLQ-C30 | TTD is defined as the time from date of randomization to first onset of PRO deterioration with or without subsequent confirmation. The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. | Approximately 5 years | 
| TTD in physical functioning scores on the EORTC QLQ-C30 | TTD is defined as the time from date of randomization to first onset of PRO deterioration with or without subsequent confirmation. The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. | Approximately 5 years | 
| TTD in role functioning scores on the EORTC QLQ-C30 | TTD is defined as the time from date of randomization to first onset of PRO deterioration with or without subsequent confirmation. The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. | Approximately 5 years | 
| TTD in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13 | TTD is defined as the time from date of randomization to first onset of PRO deterioration with or without subsequent confirmation. The EORTC QLQ-LC13 is a lung-cancer specific module that serves as an additional 13 item questionnaire to the general EORTC cancer questionnaire. It incorporates 1 multi-item scale to assess dyspnea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Scores range from 0 to 100. A high score for a symptom scale/item represents a high level of symptomatology/problems. | Approximately 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, Non-Small Lung Cancer, Seattle Genetics