ACTIVE_NOT_RECRUITING

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

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 stage 4 lung cancer lung cancer treatment lung cancer clinical trial nonsquamous lung cancer ADC Pfizer cancer trial vedotin lung disease phase 3 lung

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2024-02-21

Study Completion:2028-03-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06012435

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Pfizer CT.gov Call Center

STUDY_DIRECTOR

Pfizer

Study Locations (Sites)

Alabama Oncology

Alabaster, Alabama, 35007

United States

Alabama Oncology

Bessemer, Alabama, 35022

United States

Alabama Oncology

Birmingham, Alabama, 35205

United States

Alabama Oncology

Birmingham, Alabama, 35209

United States

Alabama Oncology

Birmingham, Alabama, 35211

United States

Alabama Oncology

Birmingham, Alabama, 35243

United States

Alaska Oncology and Hematology, LLC

Anchorage, Alaska, 99508

United States

Arizona Oncology Associates

Goodyear, Arizona, 85395

United States

Arizona Oncology Associates

Prescott, Arizona, 86301

United States

Comprehensive Blood and Cancer Center TRIO

Bakersfield, California, 93309

United States

Providence Medical Foundation

Fullerton, California, 92835

United States

Providence St. Jude Medical Center

Fullerton, California, 92835

United States

Cancer and Blood Specialty Clinic

Los Alamitos, California, 90720

United States

Cancer Blood and Specialty Clinic

Los Alamitos, California, 90720

United States

Regulatory Management Only: TRIO-US Central Administration

Los Angeles, California, 90024

United States

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

Los Angeles, California, 90095

United States

Cancer and Blood Care Specialists

Orange, California, 92868

United States

Cancer& Blood Specialty Clinic

Orange, California, 92868

United States

Providence Medical Foundation

Orange, California, 92868

United States

St. Joseph Hospital Orange

Orange, California, 92868

United States

UCSF Medical Center - Mission Bay

San Francisco, California, 94158

United States

Sansum Clinic

Santa Barbara, California, 93105

United States

Sansum Clinic

Solvang, California, 93463

United States