NCT06012435|Active Not RecruitingPhase 3DMCFDA Drug

A Study of SGN-B6A Versus Docetaxel in Previously Treated 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)

Seagen, a wholly owned subsidiary of Pfizer ClinicalTrials.gov

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3 other identifiers

SGNB6A-002C57510022023-503827-25-01

Study Type

interventional

Target

703

Locations

24 countries

Sites

335

Timeline

RegisteredAug 2023

StartedFeb 2024

CompletionMar 2028

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

703

participants targeted

Target at P75+ for phase_3

Timeline

22mo left

Started Feb 2024

Typical duration for phase_3

Geographic Reach

24 countries

335 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.1 years study duration

Study Progress55%

Feb 2024Mar 2028

First Submitted

Initial submission to the registry

August 21, 2023

Completed

4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed

6 months until next milestone

Study Start

First participant enrolled

February 21, 2024

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2026

Completed

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2028

Expected

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

August 21, 2023

Last Update Submit

March 17, 2026

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Non-Small Lung CancerSeattle Geneticslung canceradvanced lung cancermetastatic lung cancernon small cell lung cancerstage 3 lung cancerstage 4 lung cancerlung cancer treatmentlung cancer clinical trialnonsquamous lung cancerADCPfizer cancer trialvedotinlung diseasephase 3 lung

Outcome Measures

Primary Outcomes (2)

Overall survival (OS) between the experimental arm (sigvotatug vedotin) and control arm (docetaxel) in all participants and in participants whose tumors express high levels of integrin beta-6 (IB6-high)
The time from date of randomization to date of death due to any cause.
Approximately 5 years
Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) by Blinded Independent Central Review (BICR) between the experimental and control arms in all participants and in the IB6-high subgroup
The time from date of randomization to the first documented disease progression per RECIST v1.1 or to death due to any cause.
Approximately 5 years

Secondary Outcomes (18)

Confirmed Objective Response Rate (ORR) per RECIST v1.1 as assessed by BICR between the experimental and control arms in all participants and in the IB6-high subgroup
Approximately 5 years
Confirmed ORR per RECIST v1.1 by investigator assessment
Approximately 5 years
PFS per RECIST v1.1 by investigator assessment
Approximately 5 years
Duration of Response (DOR) per RECIST v1.1 by BICR
Approximately 5 years
DOR per RECIST v1.1 by investigator assessment
Approximately 5 years
+13 more secondary outcomes

Study Arms (2)

Experimental Arm

EXPERIMENTAL

sigvotatug vedotin monotherapy

Drug: sigvotatug vedotin

Control Arm

ACTIVE COMPARATOR

Docetaxel monotherapy

Drug: docetaxel

Interventions

sigvotatug vedotinDRUG

Given into the vein (IV; intravenously) on Day 1 and 15 of a 28-day cycle

Also known as: SGN-B6A; PF-08046047

Experimental Arm

docetaxelDRUG

75 mg/m\^2 given into the vein (IV; intravenously) on Day 1 of a 21-day cycle

Control Arm

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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.
+10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Seagen, a wholly owned subsidiary of Pfizerlead

Study Sites (338)

Alaska Oncology and Hematology, LLC

Anchorage, Alaska, 99508, United States

Location

Providence Medical Foundation

Fullerton, California, 92835, United States

Location

Providence St. Jude Medical Center Virginia K. Crosson Cancer Center and Infusion Center

Fullerton, California, 92835, United States

Location

Providence St. Jude Medical Center

Fullerton, California, 92835, United States

Location

Cancer and Blood Specialty Clinic

Los Alamitos, California, 90720, United States

Location

Cancer Blood and Specialty Clinic

Los Alamitos, California, 90720, United States

Location

Regulatory Management Only: TRIO-US Central Administration

Los Angeles, California, 90024, United States

Location

Drug Management Only: UCLA West Medical Pharmacy Attn: Steven L. Wong, Pharma.D.

Los Angeles, California, 90095, United States

Location

Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L Wong, Pharm.D.

Los Angeles, California, 90095, United States

Location

UCSF Medical Center - Mission Bay

San Francisco, California, 94158, United States

Location

Sansum Clinic

Santa Barbara, California, 93105, United States

Location

Sansum Clinic

Solvang, California, 93463, United States

Location