A RANDOMIZED, PHASE 3, OPEN-LABEL STUDY TO EVALUATE SIGVOTATUG VEDOTIN COMPARED WITH DOCETAXEL IN ADULT PARTICIPANTS WITH PREVIOUSLY TREATED NON-SMALL CELL LUNG CANCER (BE6A LUNG-01)
A RANDOMIZED, PHASE 3, OPEN-LABEL STUDY TO EVALUATE SIGVOTATUG VEDOTIN COMPARED WITH DOCETAXEL IN ADULT PARTICIPANTS WITH PREVIOUSLY TREATED NON-SMALL CELL LUNG CANCER (BE6A LUNG-01)
This clinical trial is studying nonsquamous 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 at least 1 drug for that genomic alteration, in addition to platinum-based chemotherapy.
This clinical trial uses an experimental drug called sigvotatug vedotin, 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 sigvotatug vedotin on Days 1 and 15 during each 28-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 sigvotatug vedotin 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.
Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of locally advanced, unresectable (Stage IIIB, IIIC), or metastatic Stage IV (M1a, M1b, or M1c) NSCLC American Joint Committee on Cancer (AJCC) Staging Manual, Version 8.0, and the Union for International Cancer Control (UICC) Staging System (Eighth edition).
Participants must have NSCLC with nonsquamous histology
Participants who have NSCLC with known actionable genomic alteration (AGAs) are permitted
Participants must have received the following prior therapies and progressed during or relapsed after receiving their most recent prior therapy:
Participants with no known AGAs must fulfill 1 of the following conditions:
Participants with known AGAs must fulfill the following conditions:
Measurable disease based on RECIST v1.1
Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with adequate baseline hematologic, hepatic, and renal function and measurable disease according to RECIST v1.1
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 sigvotatug vedotin
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:
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:
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:
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