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

Conditions

• Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• sigvotatug vedotin — DRUG
  Given into the vein (IV; intravenously) on Day 1 and 15 of a 28-day cycle
• docetaxel — DRUG
  75 mg/m\^2 given into the vein (IV; intravenously) on Day 1 of a 21-day cycle

Study Details

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.

Key Dates

Start date

Feb 21, 2024

Status verified

May 2026

Primary completion

May 18, 2026

Completion

May 17, 2028

Study Design

Enrollment

762 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Experimental Arm
  sigvotatug vedotin monotherapy
• Active Comparator: Control Arm
  Docetaxel monotherapy

Primary Outcome Measure

Overall survival (OS) between the experimental arm (sigvotatug vedotin) and control arm (docetaxel) [ Time Frame: Approximately 5 years ]

Locations (132)

Related coverage on Hipa.ai

• Sigvotatug Vedotin Phase 3 for Non-Small Cell Lung Cancer Reaches Primary…
  sigvotatug vedotin · May 18, 2026 · ClinicalTrials.gov
• Sigvotatug Vedotin Phase 3 Trial for NSCLC Reaches Primary Completion
  sigvotatug vedotin · Mar 12, 2026 · ClinicalTrials.gov

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