Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18+
Trial acronym
Be6A Lung-01
Clinical summary
Summary
Eligible participants will be randomly allocated to one of two treatment arms.
In the Experimental Arm, participants will receive an antibody drug conjugate called sigvotatug vedotin (also called SGN-B6A), which will be given intravenously (via IV) on Day 1 and 15 of a 28-day cycle.
In the Active Comparator, participants will receive docetaxel chemotherapy, which will be given intravenously on Day 1 of a 21-day cycle.
Conditions
This trial is treating people with nonsquamous non-small cell lung cancer
Eligibility
Exclusion
- 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
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Participants with any of the following respiratory conditions:
- Pre-existing peripheral neuropathy Grade greater than or equal to (≥) 2
- Uncontrolled diabetes mellitus
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Prior therapy:
- Prior treatment with antimicrotubule agents (taxanes, vinca alkaloids, or MMAEs) in the locally advanced, unresectable, or metastatic setting
- Received more than 1 prior line of cytotoxic chemotherapy in the locally advanced, unresectable, or metastatic setting
- 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.
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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
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Seagen Inc.
Scientific Title
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
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