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Compares treatment options for IO-resistant sqNSCLC
Official title A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT07217301
What this study is testing
What is TAK-928?
TAK-928 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for io-resistant sqnsclc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Lung cancer is one of the most common forms of cancer. One common type is non-small cell lung cancer (NSCLC).
- Phase 3: a large, late-stage study
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Must be able to understand and willing to sign the written informed consent form (ICF), be able to comply with the visit schedule and related...
- Male or female participants must be at least 18 years old or the legal age of majority in their country, whichever is greater. For Japan-specific...
- Have locally unresectable advanced or metastatic histologically or cytologically confirmed squamous NSCLC. Mixed small cell carcinoma, or other...
- Have had disease progression on or after prior treatment with anti-PD-1/PD-L1 therapy and platinum-based doublet chemotherapy (for example...
- Participants that have received prior anti-PD-1/PD-L1 therapy with curative intent for locally advanced disease are eligible if they meet either of...
You likely can't join if
- Women who are pregnant or breastfeeding, or intending to become pregnant before, during, or within 6 months after the last dose of any trial...
- Known actionable genomic alteration, including any of the following driver gene mutations:
- 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...
- Kirsten rat sarcoma virus (KRAS) G12C mutation.
- Anaplastic lymphoma kinase (ALK) rearrangement.
- ROS proto-oncogene 1, receptor tyrosine kinase (ROS1) rearrangement.
See the full eligibility criteria
Who can join
- Must be able to understand and willing to sign the written informed consent form (ICF), be able to comply with the visit schedule and related procedures specified in the protocol.
- Male or female participants must be at least 18 years old or the legal age of majority in their country, whichever is greater. For Japan-specific safety run-in (SRI) part of the trial, participants must be Japanese...
- Have locally unresectable advanced or metastatic histologically or cytologically confirmed squamous NSCLC. Mixed small cell carcinoma, or other pathological components are excluded. Note: For Japan-specific SRI only...
- Have had disease progression on or after prior treatment with anti-PD-1/PD-L1 therapy and platinum-based doublet chemotherapy (for example, carboplatin and paclitaxel), given either concurrently or sequentially...
- Participants that have received prior anti-PD-1/PD-L1 therapy with curative intent for locally advanced disease are eligible if they meet either of the following criteria: \- Received prior platinum-based chemotherapy...
- Provide formalin-fixed tumor tissue specimen. Fresh biopsies are preferred but archival specimens collected within 2 years before signing the informed consent form are acceptable (blocks or 10-15 unstained slides...
- Have at least 1 measurable lesion (target lesion) by computed tomography (CT) or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST) V1.1. Lesions that have previously...
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
- Expected survival time greater than or equal to (\>=) 3 months.
- Women of childbearing potential (WOCBP) must take a urine or serum pregnancy test, highly sensitive tests are required where available based on region, and must test negative for trial inclusion. WOCBP must agree to use...
- Lactating women must agree to strictly abstain from breastfeeding during the entire Treatment Period and for 6 months after the treatment.
What rules you out
- Women who are pregnant or breastfeeding, or intending to become pregnant before, during, or within 6 months after the last dose of any trial intervention. WOCBP not using and/or not willing to use at least 1 form of...
- Known actionable genomic alteration, including any of the following driver gene mutations:
- 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. Note: (a) It is not mandatory to have undergone driver gene testing. (b) For Japan-specific SRI only: This criterion...
- Participants with enlarging or symptomatic brain metastases are excluded from the trial. Participants who are neurologically, clinically and radiologically stable \>=4 weeks after definitive treatment for brain...
- 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
- 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...
- 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).
- 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).
- 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...
- 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...
- 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.
- 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...
- 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...
- History of severe, poorly controlled allergies, asthma or atopic dermatitis (except for atopic dermatitis caused by immunotherapy). Note: remote history of childhood asthma is not exclusionary.
- Uncontrolled third space effusion requiring repeated drainage, such as pleural effusion, abdominal effusion, pericardial effusion, so on. Note: Participants with the following conditions may be enrolled:
- Not requiring active drainage.
- No significant increase in effusion after stopping drainage determined using at least 2 ultrasound examinations at least 7 days apart.
- 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.
- Active autoimmune disease requiring systemic treatment (for example, use of disease-modifying drugs, corticosteroids, biologics or immunosuppressants) within 2 years before the first dose. Note: Replacement therapies...
- Known history of allogeneic organ transplantation and/or allogeneic hematopoietic stem cell transplantation.
- Known or suspected allergy to the investigational product and any excipients. Known or suspected severe hypersensitivity reactions to docetaxel or to drugs formulated with polysorbate 80.
- Prior history of significant toxicity related to immune checkpoint inhibitor (ICI) administration that required permanent discontinuation of this therapy.
- Unresolved Grade \>1 toxicity related to any previous antitumor therapy (excluding alopecia, asthenia, hypothyroidism requiring only thyroid hormone replacement therapy (HRT), hyperglycemia requiring only insulin...
- Have not adequately recovered from previous surgery or have undergone any major surgery, within 4 weeks before the first dose of investigational product.
- Uncontrolled tumor-related pain or symptomatic hypercalcemia.
- Uncontrolled human immunodeficiency virus (HIV), active syphilis, active hepatitis B virus (HBV), or hepatitis C virus (HCV).
- 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...
- Participants with positive results consistent with an untreated syphilis infection cannot enroll. Note: Testing with either a treponemal [for example, Treponema Pallidum hemagglutination TPHA or Treponema Pallidum...
- 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...
- 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.
- 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.
- 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...
- Psychiatric illness, altered mental status, or drug abuse that prevents understanding of the informed consent process and/or completion of required trial-related evaluations.
- Unable to meet protocol requirements for known or foreseeable reasons per investigator judgement.
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jonesboro, Arkansas, United States
- Fountain Valley, California, United States
- Los Alamitos, California, United States
- Torrance, California, United States
- Margate, Florida, United States
- Tamarac, Florida, United States
- Houston, Texas, United States
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Shijiazhuang, Hebei, China
- Harbin, Heilongjiang, China
- Xinxiang, Henan, China
- Zhengzhou, Henan, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Xuzhou, Jiangsu, China
- Nanchang, Jiangxi, China
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jonesboro, Arkansas, United States; Fountain Valley, California, United States; Los Alamitos, California, United States; Torrance, California, United States; Margate, Florida, United States; Tamarac, Florida, United States and 25 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.