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Comparing sigvotatug vedotin and docetaxel for advanced non-small cell lung cancer

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)

PHASE3 · Seagen Inc. · NCT06012435

This study is testing if a new drug called sigvotatug vedotin can work better than the standard treatment docetaxel for patients with advanced non-small cell lung cancer that hasn't responded to other therapies.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment670 (estimated)
Ages18 Years and up
SexAll
SponsorSeagen Inc. (industry)
Drugs / interventionschemotherapy, radiation, prednisone
Locations386 sites (Alabaster, Alabama and 385 other locations)
Trial IDNCT06012435 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of sigvotatug vedotin, an antibody drug conjugate, compared to docetaxel in patients with previously treated nonsquamous non-small cell lung cancer (NSCLC). Participants must have advanced or metastatic NSCLC that has not responded to prior treatments, including platinum-based chemotherapy and an anti-PD-(L)1 drug. The trial aims to determine if the experimental drug can provide better outcomes than the standard treatment. Patients will receive either sigvotatug vedotin or docetaxel to assess the efficacy and safety of these treatments.

Who should consider this trial

Good fit: Ideal candidates are adults with advanced or metastatic nonsquamous NSCLC who have previously received specific chemotherapy treatments.

Not a fit: Patients with squamous cell lung cancer or those who have not received prior treatments as specified may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could offer a new treatment option that may improve survival rates for patients with advanced non-small cell lung cancer.

How similar studies have performed: Other studies have shown promise with antibody drug conjugates in treating various cancers, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

  * Tumors with squamous, or predominantly squamous histology are excluded.
  * Tumors with small cell elements are excluded.
* 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:

    * Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease and a PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy), unless contraindicated.
    * Experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant or neoadjuvant setting and received a PD-(L)1 monoclonal antibody at any time during the course of treatment.
  * Participants with known AGAs must fulfill the following conditions:

    * Must have received at least 1 relevant AGA targeted therapy and in the opinion of the investigator, additional AGA targeted therapy is not in the best interest of the participant.
    * Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease, or experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant or neoadjuvant setting
    * May have received up to 1 PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).
* 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:

    * 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:

  * Prior treatment with antimicrotubule agents (taxanes, vinca alkaloids, or MMAEs) in the locally advanced, unresectable/refractory, or metastatic setting
  * Prior antimicrotubule agent exposure in curative settings (including adjuvant, neoadjuvant, or chemoradiotherapy) is permissible.
  * Received more than 1 prior line of cytotoxic chemotherapy in the locally advanced, unresectable/refractory, or metastatic setting
  * Prior cytotoxic chemotherapy in curative settings is permissible
  * 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

Where this trial is running

Alabaster, Alabama and 385 other locations

+336 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Carcinoma, Non-Small-Cell Lung, Non-Small Lung Cancer, Seattle Genetics, lung cancer, advanced lung cancer, metastatic lung cancer, non small cell lung cancer, stage 3 lung cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.