IO Resistant Squamous and Nonsquamous NSCLC study: TAK-928
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 intravenous drug being studied for immune‑onco therapy in advanced non‑small cell lung cancer.
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
- The study compares how well TAK‑928 works and how safe it is compared to the standard drug docetaxel in people with advanced or metastatic NSCLC.
- Who it's for
- Adults with unresectable, advanced or metastatic non‑small cell lung cancer who have tried other treatments.
- What's involved
- Participants receive either TAK‑928 or docetaxel and attend clinic visits for treatment, monitoring, and tests to track response and side effects.
- Time commitment
- The study can last up to 24 months, with regular clinic visits throughout the treatment period.
- 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 ICF and be able to comply with the visit schedule and related procedures specified in the...
- Male or female participants must be at least 18 years old or the legal age of majority in their country, whichever is greater.
- (a) Squamous NSCLC: Have locally unresectable advanced or metastatic histologically or cytologically confirmed squamous NSCLC.
- Received platinum-based chemotherapy in combination with anti-PD-1/PD-L1 therapy as only prior line of therapy. OR
- Received platinum-based chemotherapy and anti-PD-1/PD-L1 therapy sequentially (in either order) as the only 2 prior lines of therapy.
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...
- 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.
- ALK rearrangement.
- ROS proto-oncogene 1, ROS1 rearrangement.
- B-Raf proto-oncogene, serine/threonine kinase (BRAF) V600E mutation.
- NTRK 1/2/3 fusion.
See the full eligibility criteria
Who can join
- Must be able to understand and willing to sign the written ICF and 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. Note: For the Japan-specific SRI part, participants must be Japanese residing in Japan.
- (a) Squamous NSCLC: Have locally unresectable advanced or metastatic histologically or cytologically confirmed squamous NSCLC. Mixed small cell carcinoma, or other pathological components are excluded.
- Received platinum-based chemotherapy in combination with anti-PD-1/PD-L1 therapy as only prior line of therapy. OR
- Received platinum-based chemotherapy and anti-PD-1/PD-L1 therapy sequentially (in either order) as the only 2 prior lines of therapy.
- Received prior platinum-based chemotherapy with or without radiotherapy with maintenance anti-PD-1/PD-L1 therapy for Stage III disease and radiographic recurrence/progression within 6 months from the last dose of...
- Received prior peri-operative platinum-based chemotherapy with maintenance anti-PD-1/PD-L1 therapy for resectable Stage II/III and have radiographic recurrence within 6 months from the last dose of platinum-based...
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.
- 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.
- ALK rearrangement.
- ROS proto-oncogene 1, ROS1 rearrangement.
- B-Raf proto-oncogene, serine/threonine kinase (BRAF) V600E mutation.
- NTRK 1/2/3 fusion.
- MET proto-oncogene, MET exon 14 skipping mutation.
- RET proto-oncogene (RET) rearrangement.
- 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.
- ALK rearrangement.
- ROS1 rearrangement.
- Any other driver gene mutations listed here are excluded if known to be present, but routine testing for these or other known actionable genomic alterations is not required: BRAF V600E mutation; NTRK 1/2/3 fusion
- Participants with enlarging or symptomatic brain metastases are excluded from the trial. Participants who are neurologically, clinically and radiologically stable \>=2 weeks after definitive treatment for brain...
- Hemoglobin \<9 g/dL.
- Absolute neutrophil count (ANC) \<1,500 mm\^3.
- PLT count \<100 x 10\^3/mm\^3. \ "Baseline" is defined as the last available observation prior to the first dose of investigational product.
- Total bilirubin greater than (\>) 1.0×ULN except for participants with Gilbert's syndrome with serum bilirubin \<=3×ULN or if concurrent conjugated bilirubin \<=ULN.
- AST or ALT \>2.5×ULN without concomitant alkaline phosphatase \>2.5×ULN or AST or ALT \>1.5×ULN with concomitant alkaline phosphatase \>2.5×ULN.
- Creatinine clearance (CrCl) \<30 milliliters 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).
- 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 the investigator...
- 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 msec.
- Uncontrolled hypertension despite standard treatment.
- History of myocarditis.
- Left ventricular ejection fraction \<50%.
- 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.
- History of or current ILD; history or current presence of the following lung diseases requiring corticosteroid therapy: pulmonary fibrosis, and drug-related, immune-related or radiation pneumonitis
- 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, or pericardial effusion.
- Flare of inflammatory bowel disease (within 6 months prior to the first dose of the investigational product).
- Grade \>=2 diarrhea 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 \>10 milligrams (mg) daily equivalent of prednisone, biologics or immunosuppressants) within 2 years...
- 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 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.
- 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°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 exception of radically treated basal cell carcinoma of skin, squamous cell carcinoma of skin, carcinoma in situ...
- Docetaxel.
- Received more than 1 anti-PD-1/PD-L1 therapy in metastatic or recurrent unresectable locally advanced setting.
- Systemic antitumor therapy except anti-PD-1/PD-L1 therapy and platinum-based doublet chemotherapy including but not limited to targeted therapy, antibody drug conjugates, cell therapies, and other ICIs.
- One prior line of anti-VEGF antibody administered in combination with 1L ICI and chemotherapy is allowed.
- For participants with KRAS mutations, 1 prior line of RAS-targeted therapy is allowed. Note: For Japan-specific SRI part only: The above listed 3 limitations regarding prior systemic antitumor therapy do not apply to...
- 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 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 first dose of investigational product.
- Immunosuppressive or systemic corticosteroid 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 is enrolling
- Jonesboro, Arkansas, United States
- Fair Oaks, California, United States
- Fountain Valley, California, United States
- Los Alamitos, California, United States
- Torrance, California, United States
- Washington D.C., District of Columbia, United States
- Margate, Florida, United States
- Tamarac, Florida, United States
- Springfield, Missouri, United States
- New York, New York, United States
- Knoxville, Tennessee, 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
- Xinxiang, Henan, China
- Zhengzhou, Henan, China
+ 12 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, but 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?
This study is enrolling now at Jonesboro, Arkansas, United States; Fair Oaks, California, United States; Fountain Valley, California, United States; Los Alamitos, California, United States; Torrance, California, United States; Washington D.C., District of Columbia, United States and 26 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.