A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer
Public ClinicalTrials.gov record NCT07217301. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07217301
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 600 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 25, 2025
- Primary completion
- Oct 31, 2028
- Completion
- Nov 30, 2029
- Last update posted
- Aug 3, 2026
2025 – 2029
United States locations
- U.S. sites
- 8
- U.S. states
- 4
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Bernards Healthcare | Jonesboro | Arkansas | 72401 | Recruiting |
| Apex Research | Fair Oaks | California | 95628 | Recruiting |
| Memorial Care | Fountain Valley | California | 92708 | Recruiting |
| Cancer and Blood Specialty Clinic | Los Alamitos | California | 90720 | Recruiting |
| Translation Research in Oncology- US, INC (TRIO-US) | Torrance | California | 90505 | Recruiting |
| D & H Cancer Research Center | Margate | Florida | 33063 | Recruiting |
| BRCR Global | Tamarac | Florida | 33322 | Recruiting |
| The University of Texas M.D Anderson Cancer Center (MDACC) | Houston | Texas | 77030 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 37 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07217301, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 3, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07217301 live on ClinicalTrials.gov.