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New treatment option for Lung Cancer
Official title A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastases From NSCLC (Non-small Cell Lung Cancer)
ClinicalTrials.gov ID: NCT06822543
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, being studied as a potential treatment for 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
- This is a Phase II, single-arm, multicenter trial for patients with metastatic non-small cell lung cancer who have brain metastases and no known actionable mutations. Eligible patients will receive a combination of Datopotamab-deruxtecan, Carboplatin, and Pembrolizumab every three weeks for four cycles, followed by maintenance therapy with Datopotamab-deruxtecan and Pembrolizumab until disease progression or intolerable toxicity.
- Phase 2: a mid-size study of how well it works
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
- \- Male/female participants who are at least 18 years of age on the day of signing informed consent with a histologically confirmed diagnosis of...
- Documented negative test results for EGFR and ALK actionable genomic alterations by local test;
- No known actionable genomic alterations in ROS1, NTRK, RET, HER2, or MET.
- No prior systemic therapy for advanced or metastatic NSCLC. Patients who received chemotherapy or immunotherapy for localized or locally advanced...
- Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs...
You likely can't join if
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to inclusion.
- Has received prior radiotherapy to the brain within 2 weeks of the start of therapy, or received radiotherapy to the chest within 4 weeks of start of...
- Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines...
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or...
- Has spinal cord compression.
See the full eligibility criteria
Who can join
- \- Male/female participants who are at least 18 years of age on the day of signing informed consent with a histologically confirmed diagnosis of NSCLC will be enrolled in this study. Histologically confirmed metastatic...
- Documented negative test results for EGFR and ALK actionable genomic alterations by local test;
- No known actionable genomic alterations in ROS1, NTRK, RET, HER2, or MET.
- No prior systemic therapy for advanced or metastatic NSCLC. Patients who received chemotherapy or immunotherapy for localized or locally advanced NSCLC are eligible if progression occurred at least 6 months after the...
- Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who...
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Have measurable disease based on RECIST 1.1, including the following: Presence of 1 or more measurable central nervous system (CNS) metastases that have not received prior radiation therapy, or presence of 1 or more...
- No leptomeningeal carcinomatosis.
- Archival tumor tissue sample or newly obtained [core, incisional or excisional] biopsy of a tumor lesion has been provided. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slide (preferably a...
- Negative pregnancy test (serum) for women of childbearing potential.
- Have adequate organ function. Specimens must be collected within 10 days prior to the start of study intervention.
- Hematological: Absolute neutrophil count (ANC) ≥1500/µL; Platelets ≥100 000/µL; Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/La;
- Renal: Creatinine OR Measured or calculatedb creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN
- Hepatic: Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
- Coagulation: International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within...
- ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.
- Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within the last 2 weeks.
- Creatinine clearance (CrCl) should be calculated per institutional standard.
What rules you out
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to inclusion.
- Has received prior radiotherapy to the brain within 2 weeks of the start of therapy, or received radiotherapy to the chest within 4 weeks of start of therapy, or that have ongoing radiation-related toxicities requiring...
- Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the...
- Has spinal cord compression.
- Uncontrolled or significant cardiovascular disease, including: Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) interval \>470 msec regardless of sex; Myocardial infarction within 6 months...
- Known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in...
- Has severe hypersensitivity (≥Grade 3) to either pembrolizumab and/or any of its excipients and/or Dato-DXd including its excipients (e.g. polysorbate 80).
- Has a history of non-infectious ILD/pneumonitis including radiation pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses (including pulmonary embolism within 3 months of enrollment, severe asthma, severe oxygen-dependent chronic obstructive pulmonary...
- Clinically significant known corneal disease.
- Known active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).
- Severe infection within 4 weeks prior to the first dose of study treatment (Cycle 1, Day 1), including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.
- Treatment with oral or IV antibiotics within 2 weeks prior to initiation of study treatment (Cycle 1, Day 1).
- Has not adequately recovered from major surgery or has ongoing surgical complications.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full...
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting 3 months before Cycle 1 Day 1 and continuing for at least 6 months for male people and 7...
- Female participants must be at least 1 year post-menopausal, surgically sterile, or using at least 1 highly effective form of birth control (a highly effective method of contraception is defined as one that can achieve...
- Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile or use an acceptable method of contraception from the time of screening throughout the total...
- Has had an allogenic tissue/solid organ transplant.
The study team makes the final eligibility decision.
Where it's taking place
- São José do Rio Preto, São Paulo, Brazil
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 São José do Rio Preto, São Paulo, Brazil. 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.