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

This study is for adults with a type of lung cancer called non-small cell lung cancer (NSCLC) that has spread or cannot be removed by surgery, and has stopped responding to immunotherapy (IO-resistant). You would receive either TAK-928 or a comparator drug, both given through an IV. Researchers want to see how many people respond to the treatment and how long they live. They will also look at side effects. To join, you must be at least 18 years old and willing to sign an informed consent form. The study plans to enroll 600 participants, but its current status is unclear.

Study design: This interventional study plans to enroll 600 participants. It compares TAK-928 with a control drug.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Researchers will measure how many people respond to treatment for up to 26 months, and overall survival for up to 26 months. They will also track dose-limiting toxicities for up to 28 days after the first dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

PHASE3Ages 18+InterventionalTreatment

Takeda

~600 participants

Updated 2026-08-04 on ClinicalTrials.gov

What's tested:TAK-928Control Arm

At a glance

Recruiting sites

33 of 46 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

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

Measured over Up to 26 months

+3 more outcomes measured

Conditions

IO-resistant sqNSCLC

NCT07217301

Where you'd take part

This study runs at 46 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Guangzhou, Guangdong, Chinastudy coordinator listed
Recruiting
Anhui Provincial Cancer Hospital
Hefei, Anhui, Chinastudy coordinator listed
Not yet recruiting
Anhui Provincial Hospital
Hefei, Anhui, Chinastudy coordinator listed
Recruiting
Apex Research
Fair Oaks, Californiastudy coordinator listed
Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, Chinastudy coordinator listed
Recruiting
BRCR Global
Tamarac, Floridastudy coordinator listed
Recruiting
Cancer and Blood Specialty Clinic
Los Alamitos, Californiastudy coordinator listed
Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, Chinastudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Study Director · STUDY_DIRECTOR · Takeda

Who to contact

Takeda Contact

[email protected]

877-825-3327 · ext. +1

Email the study team

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Eligibility criteria

Exclusion

Epidermal growth factor receptor (EGFR): including exon 19 deletion, exon 21 L858R, exon 20 T790M, exon 20 S768I, exon 21 L861Q, exon 18 G719X, and exon 20 insertion mutations.

Kirsten rat sarcoma virus (KRAS) G12C mutation.

Anaplastic lymphoma kinase (ALK) rearrangement.

ROS proto-oncogene 1, receptor tyrosine kinase (ROS1) rearrangement.

B-Raf proto-oncogene, serine/threonine kinase (BRAF) V600E mutation.

Neurotrophic tyrosine receptor kinase (NTRK) 1/2/3 fusion.

MET proto-oncogene, receptor tyrosine kinase (MET) exon 14 skipping mutation.

RET proto-oncogene (RET) rearrangement.

V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2 (ERBB2, also known as HER2) mutation.

No metastases to meninges, midbrain, pons, medulla oblongata (leptomeningeal metastases), or cerebellar metastases.

No compression of the aqueduct of Sylvius, no compression of the third or fourth ventricle.

No participant with epidural spinal cord compression or spinal cord metastases.

Participants must be off steroids for at least 7 days for CNS disease. Systemic steroids of \<=10 milligrams per day (mg/day) of prednisone or equivalent are acceptable if needed for other indications.

CNS-related symptoms must be stable \>=14 days prior to randomization

Brain metastases should not be included as RECIST V1.1 target lesions 4. Presence of any of the following hematologic abnormalities at baseline\*:

Hemoglobin \<9 grams per deciliter (g/dL).

Absolute neutrophil count (ANC) \<1,500 per cubic millimeters (mm\^3).

Platelet (PLT) count \<100 x 10\^3/mm\^3. \*"Baseline" is defined as the last available observation prior to the first dose of investigational product. Note: Participants must not receive supportive treatments such as blood products (including RBC suspension, apheresis platelets, cryoprecipitation, and so on.) within 7 days of confirming eligibility. Erythropoietin or colony-stimulating factors must not be administered within 28 days of confirming eligibility. 5. Presence of any of the following serum chemistry abnormalities at baseline:

Total bilirubin greater than (\>) 1.5×upper limit of normal (ULN) except for participants with Gilbert's syndrome with serum bilirubin \<=3×ULN or if concurrent conjugated bilirubin \<=ULN.

Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3×ULN; for liver metastasis, AST or ALT \>5×ULN.

Creatinine clearance (CrCl) \<30 milliters per minute (mL/min); the Cockcroft-Gault formula is used to calculate CrCl (using ideal body weight for obese participants and actual body weight for non-obese participants).

Albumin \<30 grams per liter (g/L). 6. Presence of any of the following coagulation parameter abnormalities at baseline:

International normalized ratio (INR) \>1.5×ULN (\>3×ULN if on stable dose anticoagulation).

Partial thromboplastin time (PTT; or activated partial thromboplastin time \[aPTT\]) \>1.5×ULN (\>3×ULN if on stable-dose anticoagulation). 7. History of deep venous thrombosis, pulmonary embolism, or any other serious thromboembolic events within 30 days prior to enrollment (implantable port or catheter-related thrombosis, or superficial venous thrombosis are not considered "serious" thromboembolisms). Participants with a history of serious thromboembolic event must be asymptomatic and on stable anticoagulation therapy (if such therapy is deemed necessary by the treating physician). 8. Active uncontrolled bleeding, known bleeding diathesis, or significant concern for risk of acute life-threatening bleeding (for example, radiographic evidence that tumor invades large blood vessels or has unclear boundaries with a major vessel \[including aorta, left pulmonary artery, right pulmonary artery, pulmonary vein, superior vena cava, inferior vena cava, and so on\], or the investigator judges that the tumor is very likely to invade major vessels with the potential to cause fatal bleeding during the duration of the trial). 9. Presence of clinically significant cardiovascular or cerebrovascular diseases, including:

Symptomatic, clinically unstable arrhythmia or arrhythmia requiring clinical intervention.

Severe conduction disorders (such as third-degree atrioventricular block and bundle branch block).

QT interval corrected for heart rate (QTc interval, calculated using Fridericia's formula) \>=480 milliseconds (msec).

Uncontrolled hypertension (systolic blood pressure \>=160 millimeters of mercury (mmHg) or diastolic blood pressure \>=100 mmHg) despite standard treatment.

History of myocarditis.

Left ventricular ejection fraction \<50 percent (%).

Congestive heart failure requiring treatment.

Class II to IV cardiac insufficiency according to the New York Heart Association functional classification.

History of acute coronary syndrome (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to the first dose of investigational product.

Cerebrovascular accident or transient ischemic attack within 6 months before the first dose of the investigational product.

History of seizures unless controlled on stable dose of antiseizure medications. 10. Cardiac enzymes \>=levels consistent with acute myocardial infarction as defined by laboratory-specific criteria. Participants with isolated Grade 1 elevated cardiac enzymes require cardiology clearance and consultation with the sponsor's medical monitor to confirm absence of ongoing myocardial/ischemic disease. 11. History of or current interstitial lung disease (ILD), pulmonary fibrosis, and drug-related, immune-related and radiation pneumonitis; current active pulmonary infection requiring anti-infective therapy; active pulmonary tuberculosis (TB) within 1 year prior to enrollment; severely impaired pulmonary function, including but not limited to the following: pulmonary embolism, severe asthma or chronic obstructive pulmonary disease within 3 months prior to randomization; autoimmune, connective tissue, or inflammatory diseases involving the lungs (such as rheumatoid arthritis, Sjögren's disease, and sarcoidosis); previous unilateral pneumonectomy.

Not requiring active drainage.

No significant increase in effusion after stopping drainage determined using at least 2 ultrasound examinations at least 7 days apart. 14. Current or recent significant gastrointestinal disease or condition, including:

Flare of inflammatory bowel disease (within 6 months prior to the first dose of the investigational product).

Grade \>=2 diarrhea Common Terminology Criteria for Adverse Events (CTCAE V5.0) within 2 weeks prior to the first dose of the investigational product. 15. Active autoimmune disease requiring systemic treatment (for example, use of disease-modifying drugs, corticosteroids, biologics or immunosuppressants) within 2 years before the first dose.

Participants who are HIV-positive must have CD4 \>=350 cells per microliter (cells/µL) and must be on established highly active antiretroviral therapy (ensure no expected drug-drug interactions) for at least 4 weeks with an HIV viral load \<400 copies per milliliter (copies/mL).

Participants with positive results consistent with an untreated syphilis infection cannot enroll.

Participants with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) should undergo HBV DNA testing. If the HBV DNA copy number is \<=2.5×10\^3 copies/mL or \<=500 international units per milliliter (IU/mL) or below the lower limit of detection, the participant can be enrolled. Participants who are HBsAg (+) should receive anti-HBV treatment throughout the treatment period to avoid viral activation. For participants with anti-hepatitis B core antibody (anti-HBcAb) (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV treatment can be considered but is not required; however, close monitoring for viral reactivation is required.

Participants with positive HCV serology results must have an HCV RNA viral load that is negative or below the lower limit of detection.

Participants who have received definitive HCV treatment and have undetectable viral load results are allowed. 23. Serious/active/uncontrolled infection, infection requiring systemic intravenous antibiotics, or fever of unknown origin (\>=38 degree celsius \[°C\]) within 2 weeks before the first dose of investigational product. 24. History or current evidence of any disease, treatment, or laboratory abnormality that, in the judgment of the investigator, could compromise the safety of the participant, interfere with obtaining informed consent, affect participant compliance, or affect safety evaluations of the investigational product. 25. Psychiatric illness, altered mental status, or drug abuse that prevents understanding of the informed consent process and/or completion of required trial-related evaluations. 26. Unable to meet protocol requirements for known or foreseeable reasons per investigator judgement. 27. Diagnosed with other pathologically confirmed malignancies within 5 years prior to informed consent, with the exception of radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ, localized prostate cancer, papillary thyroid cancer, and other radically treated malignancies with no known active disease for at least 2 years prior to enrollment and with a very low risk of recurrence. 28. Received any of the following excluded medications or treatments:

Docetaxel.

Received more than 1 anti-PD-1/PD-L1 therapy in the metastatic or recurrent unresectable locally advanced setting. Prior anti-PD-1/PD-L1 therapy in the curative locally advanced setting followed by anti-PD-1/PD-L1 therapy in the metastatic or recurrent unresectable locally advanced setting is allowed, not to exceed 2 prior lines of anti-PD-1/PD-L1 therapy in total.

Systemic antitumor therapy except anti-PD-1/PD-L1 therapy and platinum-based doublet chemotherapy including but not limited to bispecific antibodies, targeted therapy, antibody drug conjugate, cell therapies, and other ICIs.

Interleukin (IL)-2 or IL-15 cytokines or related therapies.

Chemotherapy within 2 weeks or 5 half-lives (whichever is longer) before the first dose of investigational product without delayed toxicity.

Antitumor antibody therapy (excluding antibody drugs such as denosumab for the treatment of bone metastases) within 4 weeks before the first dose of the investigational product.

Palliative radiotherapy within 2 weeks prior to the first dose of investigational product.

Live vaccine within 28 days prior to the first dose of investigational product.

Immunosuppressive or systemic steroid therapy (\>10 mg/day of prednisone or equivalent) within 2 weeks prior to the first dose of investigational product.

Received traditional Chinese medicine with potential antitumor activity or known antitumor indications within 1 week before the first dose of the investigational product.

What this trial measures

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)1.1Up to 26 months
cORR is defined as the proportion of participants with confirmed objective response rate (complete response \[CR\] or partial response \[PR\]) per RECIST V1.1 CR is defined as complete disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non- target) must have reduction in short axis to less than (\<) 10 mm. PR is defined as at least a 30 percent decrease in the sum of the diameters of target lesions, taking as reference the Baseline sum diameters.
Global Part: Overall Survival (OS)Up to 26 months
To compare the overall survival (OS) of TAK-928 (treatment group) versus docetaxel (control group) in participants with unresectable locally advanced or metastatic squamous NSCLC with disease progression on or after platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy.
SRI Part: Percentage of Participants with Dose-limiting Toxicities (DLTs)Up to 28 days after first dose (Day 1)
DLT will be defined as any of the adverse events (AEs) specified in the protocol that occur within the DLT observation period, is not attributable to disease or other extraneous factors and potentially related to the intervention following the first dose. Toxicity will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.
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 DeathsFrom screening up to 26 months
AE: Any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial intervention, whether or not there is a causal relationship with any trial intervention, including, but not limited to, following: Exacerbation of pre-existing medical conditions/diseases (including worsening of symptoms, signs, laboratory abnormalities) temporally associated with the use of trial intervention; any newly developed adverse medical conditions (including symptoms, signs and newly diagnosed diseases) and clinically significant abnormal laboratory values or results. TEAE: Any AE that starts after the first administration of study drug. SAE: Any untoward medical occurrence that meets at least one of the following criteria: Results in death; is life threatening; requires inpatient hospitalization or prolongation of hospitalization. irAEs may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously.

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