Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07217301
PHASE3

A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer

Sponsor: Takeda

View on ClinicalTrials.gov

Summary

Lung cancer is one of the most common forms of cancer. One common type is non-small cell lung cancer (NSCLC). NSCLC happens when abnormal cells in the lungs grow too fast. This can stop the lungs from working normally. This study focuses on NSCLC in later stages (advanced). This means that the cancer has spread to other parts of the body (metastatic) or cannot be removed with surgery (unresectable). People with unresectable, advanced or metastatic NSCLC often get treatment with immunotherapy and/or platinum-based chemotherapy (such as cisplatin or carboplatin). Immunotherapy helps the body's germ-fighting (immune) system fight cancer. Chemotherapy kills cancer cells or slows their growth. Over time, these treatments may stop working and the cancer can get worse. Researchers are looking for ways to make immunotherapy work better. One approach is to help the immune system recognize cancer more easily by activating certain cells, called T cells, to attack and kill the tumor cells. TAK-928 is designed to attach to T cells in the tumor and make them more active and abundant. This may help the body fight the cancer and destroy tumor cells. The main aim of this study is to learn how well TAK-928 works and compares with the usual treatment (also called standard of care), docetaxel, in adults with unresectable, advanced or metastatic NSCLC. Another aim is to learn how safe TAK-928 is in adults with NSCLC. The participants can be treated for up to 2 years (24 months) depending on how a participant responds, side effects, or other reasons. Researchers will check a participant's condition until the treatment is ended. During the study, participants will visit the study clinic several times.

Official title: A Randomized, Open Label, Multicenter, Phase 3 Trial Evaluating the Efficacy and Safety of TAK-928 Versus Docetaxel in Participants With Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Disease Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2025-11-26

Completion Date

2029-12-01

Last Updated

2026-07-10

Healthy Volunteers

No

Interventions

DRUG

TAK-928

TAK-928 will be administered by IV infusion.

DRUG

Control Arm

Comparator product will be administered by IV infusion.

Locations (45)

St. Bernards Healthcare

Jonesboro, Arkansas, United States

Memorial Care

Fountain Valley, California, United States

Cancer and Blood Specialty Clinic

Los Alamitos, California, United States

Translation Research in Oncology- US, INC (TRIO-US)

Torrance, California, United States

D & H Cancer Research Center

Margate, Florida, United States

BRCR Global

Tamarac, Florida, United States

The University of Texas M.D Anderson Cancer Center (MDACC)

Houston, Texas, United States

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

Anhui Provincial Hospital

Hefei, Anhui, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Guangzhou, Guangdong, China

The Fourth Hospital of Hebei University

Shijiazhuang, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Shandong Cancer Hospital

Jinan, Shandong, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Xi'An Jiaotong University

Xi'an, Shannxi, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

National Cancer Center

Tokyo, Japan