Learn about a clinical trial for patients who have not been treated for PD-L1 high, Stage IIIb, Stage IIIc, or Stage IV NSCLC. Connect with a clinical trial site.

The Be6A LUNG-02 Clinical Trial is an open-label, randomized, Phase 3 study of sigvotatug vedotin, in combination with pembrolizumab, versus pembrolizumab monotherapy as first-line treatment in participants with PD-L1 high, locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC).

Inclusion criteria

  • Age: 18+ years
  • Condition: Pathologically confirmed Stage IIIB or IIIC NSCLC and not a candidate for surgical resection or definitive chemoradiation, or Stage IV NSCLC
  • Biomarker: Tumor has PD-L1 expression in ≥ 50% of tumor cells
  • Documented negative test results for EGFR, ALK, and ROS1

Inclusion criteria

Man consulting doctor in clinic | Pfizer clinical trials
Man consulting doctor in clinic | Pfizer clinical trials

Exclusion criteria

Doctor consulting patient in clinic | Pfizer clinical trials
Doctor consulting patient in clinic | Pfizer clinical trials

Exclusion criteria

  • No known actionable genomic alterations (AGAs) in NTRK, BRAF, RET, MET, or other actionable genomic alterations with approved front-line therapies per local standard of care
  • No prior treatment with MMAE-derived drugs or IB6-targeting agents, or systemic therapy (including anti-PD-(L)1 therapy) for locally advanced, unresectable, or metastatic NSCLC (with some exceptions)
  • No history of another malignancy within 3 years (with certain exceptions)
  • No significant pulmonary disease unrelated to underlying malignancy
  • No known active CNS lesions
  • No uncontrolled diabetes
  •  No radiotherapy to the lung within 6 months

Get started

Answer a 2-minute questionnaire and speak to a study representative.

A first step as you consider connecting with a Principal Investigator is to answer a 2-minute online questionnaire about your interest and willingness to be contacted. If your answers show the study might be a good fit for you and your patient, you may choose to have your contact information shared with a study clinic that you select for further discussion.

Get connected.

Your answers to these questions will only be linked to you if your responses indicate that you would like to be connected with a Principal Investigator and you choose to share your contact information with the study clinic. Pfizer study team members and our partners will have access to reports containing aggregated data that will not be directly linked back to you. Only the study staff can determine if your patient meets the study’s eligibility criteria and is able to enroll in the study.

About the Study Treatment

About Sigvotatug Vedotin

  • Sigvotatug vedotin is an investigational antibody-drug conjugate (ADC) designed to deliver the cytotoxic payload monomethyl auristatin E (MMAE) to tumor cells expressing integrin beta-6 (IB6)1
  • IB6 is a surface cell receptor overexpressed in multiple solid tumors such as non-small cell lung cancer, head and neck cancer, and esophageal cancer1,2
  • Preliminary clinical evidence demonstrates antitumor activity and a manageable safety profile in untreated, locally advanced/metastatic NSCLC participants treated with sigvotatug vedotin plus pembrolizumab

Participants will be randomized 1:1 to receive either:

  • Sigvotatug vedotin + pembrolizumab combination therapy
  • Pembrolizumab monotherapy

Cycle length: 42 days
Sigvotatug vedotin IV Q2W (Days 1, 15, and 29)
Pembrolizumab IV Q6W (Day 1)

What patients can expect

  • Participants will receive pembrolizumab; some may also receive sigvotatug vedotin—there is no placebo
  • All required activities happen on the same day as treatment (except for Cycle 1), minimizing the number of visits
  • Ride assistance and travel/gas reimbursement are available

Proposed Mechanism of Action

Sigvotatug vedotin is thought to induce tumor cell death through:

  • Direct cytotoxicity via preferential release of MMAE within target cells and subsequent apoptosis
  • The bystander effect
  • Immunogenic cell death3,4

About IB6-Overexpressing Cancers

IB6 is a member of the integrin family of proteins involved in cellular adhesion, motility, and cytokinesis. IB6 is expressed at low levels in normal adult epithelial tissues, but expression is induced by tissue injury due to its role in wound repair.5 High levels of IB6 expression have been demonstrated in different types of cancer1 and are associated with poor prognosis based on multiple retrospective analyses.6,7 Additional investigations suggest tumors may exploit the remodeling function associated with IB6 to promote invasiveness and metastasis.8,9

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References

1. Lyon RP, Jonas M, Frantz C, et al. SGN-B6A: a new vedotin anti-drug conjugate directed to integrin beta-6 for multiple carcinoma indications. Mol Cancer Ther. 2023;22(12):1444-1453. doi:10.1158/1535-7163. MCT-22-0817
2. Brzozowska E, Deshmukh S. Integrin alpha v beta 6 (α v β6) and its implications in cancer treatment. Int J Mol Sci. 2022;23:(20):12346. doi:10.3390/ijms232012346
3. Lyon R, Trang V, Gosnik JJ, et al. Abstract 1522: SGN-B6A induces immunogenic cell death as an additional mechanism of action. J ImmunoTher Cancer. 2022; 10(suppl 2). doi:10.1136/jitc-2022-SITC2022. 1186
4. Trang VH, Mazahreh R, Gosnik JJ, et al. Abstract 1522: SGN-B6A induces immunogenic cell death as an additional mechanism of action. Cancer Res. 2023;83(suppl 7):1522-1522. doi:10.1158/1538-7445.am2023-1522
5. Van Aarsen LA, Leone DR, Ho S, et al. Antibody-mediated blockade of integrin alpha v beta 6 inhibits tumor progression in vivo by transforming growth factor-beta-regulated mechanism. CancerRes. 2008;68(2):561-570.doi:10.1158/008-5472.CAN07-0245
6. Elayadi AN, Samli KN, Prudkin L, et al. A peptide selected by biopanning identifies the integrin alphabeta6 as a prognostic biomarker for nonsmall cell lung cancer. Cancer Res. 2007:67(12):5889-5895.
7. Elez E, Kocakova I, Hokler T, et al. Abituzumab combined with cetuximab plus irinotecan versus cetuximab plus irinotecan alone for patients with KRAS wild-type metastatic colorectal cancer: the randomised phase I/II POSEIDON trial. Ann Oncol. 2015;26(1):13-140. doi:10.1093/annonc/mdu474
8. Hamidi H, Ivaska J. Every step of the way: integrins in cancer progression and metastasis. Nat Rev Cancer. 2018:18(9):533-548. doi:10.1038/s41568-018-0038-z
9. Marsh D, Dickinson S, Neill GW, Marshall JF, Hart IR, Thomas GJ. Apha vbeta 6 integrin promotes the invasion of morphoeic basal cell carcinoma through stromal modulation. Cancer Res. 2008:68(9):3295-3303.doi:10.1158/0008-5472.CAN-08-0174