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)

Status: Active_not_recruiting

Location: See all (337) locations...

Intervention Type: Drug

Study Type: Interventional

Study Phase: Phase 3

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• 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

Locations

United States

Alaska

Alaska Oncology and Hematology, LLC

Anchorage

California

Providence Medical Foundation

Fullerton

Providence St. Jude Medical Center

Fullerton

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

Fullerton

Cancer and Blood Specialty Clinic

Los Alamitos

Cancer Blood and Specialty Clinic

Los Alamitos

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

Los Angeles

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

Los Angeles

TRIO US Central Administration

Los Angeles

UCSF Medical Center - Mission Bay

San Francisco

Sansum Clinic

Santa Barbara

Sansum Clinic

Solvang

Colorado