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Life sciences · Phase 3 Trial
ClinicalTrials.gov · November 2, 2026
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Phase 3 Trial.
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Registry record from ClinicalTrials.gov (NCT07217301). This is a study registration, not published results. Lead sponsor: Takeda. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 1200 participants (ESTIMATED). Conditions: IO Resistant Squamous and Nonsquamous NSCLC. Interventions: DRUG: TAK-928; DRUG: Control Arm. Primary outcome measures: Squamous NSCLC Part: Confirmed Objective Response Rate (cORR) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version (V)1.1 , Up to 26 months; Squamous and Nonsquamous NSCLC Part: Overall Survival (OS) , Up to 26 months; SRI Part: Percentage of Participants with Dose-limiting Toxicities (DLTs) , Up to 28 days after first dose (Day 1); SRI Part: Percentage of Participants With Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), Immune-Related Adverse Events (irAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation and Deaths , From screening up to 26 months. Brief 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. NSCLC can be divided into types based on where cancer starts. Some NSCLC starts in the cells that line the larger airways near the center of the lungs. This is called squamous NSCLC. Other NSCLC often starts in the outer parts of the lungs, in cells that make mucus. This is called nonsquamous NSCLC. This study focuses on squamous and nonsquamous 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 squamous or nonsquamous 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. This may make the T-cells more active and increase their number. 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 squamous or nonsquamous 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). Total treatment duration can vary 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.