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

Conditions

• IO-resistant sqNSCLC

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• TAK-928 — DRUG
  TAK-928 will be administered by IV infusion.
• Control Arm — DRUG
  Comparator product will be administered by IV infusion.

Study Details

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.

Key Dates

First listed

Oct 15, 2025

Start date

Nov 26, 2025

Status verified

Jul 2026

Primary completion

Nov 1, 2028

Completion

Dec 1, 2029

Study Design

Enrollment

600 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: TAK-928
  TAK-928 is a first-in-class bispecific monoclonal antibody (mAb) comprised of an interleukin-2 (IL-2) mutein fused with a recombinant anti-programmed cell death protein 1 (anti-PD-1) mAb. TAK-928 was precisely designed and constructed to afford targeted binding of tumor-specific CD8+ T cells (TSTs) that co-express PD-1 and CD25 (IL2Ra) receptors. The mechanism of action of TAK-928 is blocking the PD-(L)1 and activating the IL-2 pathways simultaneously to reverse T cell exhaustion and promote activation of T cells and natural killer (NK) cells, and consequently eliminate tumor cells.
• Active Comparator: Control
  Docetaxel or comparable generic brand

Primary Outcome Measure

Global 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 [ Time Frame: Up to 26 months ]

Central Contacts

• Takeda Contact
  877-825-3327
  [email protected]

Locations (7)

Find similar trials in Jonesboro, AR