Actively Recruiting
A Phase 2 Single Arm Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-Naive Brain Metastases from Non-Small Cell Lung Cancer
Led by Latin American Cooperative Oncology Group · Updated on 2025-09-29
46
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
L
Latin American Cooperative Oncology Group
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment for patients with metastatic non-small cell lung cancer (NSCLC) who have brain metastases but no known actionable mutations. This phase II, single-arm, multicenter trial aims to assess the effectiveness of Datopotamab-deruxtecan combined with Carboplatin and Pembrolizumab. The study focuses on patients who have not received prior systemic therapy for advanced NSCLC and measures brain tumor responses using established criteria over an average of two years. Participants will receive an induction phase of treatment every three weeks for four cycles, including Datopotamab-deruxtecan 6 mg/kg, Carboplatin, and Pembrolizumab 200 mg. Following this, they will continue maintenance therapy with Datopotamab-deruxtecan and Pembrolizumab until disease progression or unacceptable side effects occur. If brain tumors progress without systemic disease worsening, patients may undergo stereotactic radiosurgery and continue systemic therapy depending on the investigator's decision. Throughout the study, patients will have medical evaluations and laboratory tests every three weeks. Imaging scans of the abdomen, pelvis, chest, and brain will be done at baseline, every six weeks for the first 24 weeks, then every nine weeks afterward. Patient-reported outcomes will be collected using questionnaires during treatment. The main outcome measured is the confirmed response rate of brain metastases based on specific imaging criteria, with safety and quality of life also monitored.
CONDITIONS
Brief 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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with histologically confirmed non-squamous metastatic non-small cell lung cancer (NSCLC)
- PD-L1 tumor proportion score less than 50% as determined by local or central testing
- Negative for actionable mutations in EGFR, ALK, ROS1, NTRK, RET, HER2, and MET
- No prior systemic therapy for advanced or metastatic NSCLC; prior treatment for localized disease allowed if progression was at least 6 months after last dose
- Recovery to Grade 1 or baseline from previous therapy side effects; stable endocrine-related side effects and neuropathy Grade 2 or less allowed
- Measurable disease by RECIST 1.1 including brain metastases meeting size criteria
- No neurological symptoms requiring immediate significant intervention; controlled neurological symptoms allowed
- No leptomeningeal carcinomatosis
- Provided tumor tissue sample for testing
- ECOG performance status 0 to 1
- Life expectancy greater than 12 weeks
- Adequate treatment washout periods before starting study treatment
- If hepatitis B positive, on antiviral therapy with undetectable viral load
- Controlled hepatitis C or HIV infection meeting specified criteria
- Negative pregnancy test for women of childbearing potential
- Adequate organ function based on blood counts, liver and kidney tests
- Written informed consent provided
You will not qualify if you...
- Prior systemic anti-cancer therapy within 4 weeks before study start
- Recent brain radiotherapy within 2 weeks or chest radiotherapy within 4 weeks before treatment start
- Live vaccine administered within 30 days before first dose
- Recent use of investigational agents or devices within 4 weeks
- Immunodeficiency or use of high-dose systemic steroids or immunosuppressants within 7 days before treatment
- Spinal cord compression
- Uncontrolled or significant heart disease or abnormal heart function
- Other progressing malignancies requiring treatment within past 5 years
- Severe hypersensitivity to study drugs or their components
- History or current interstitial lung disease or pneumonitis not ruled out
- Serious lung diseases or autoimmune diseases affecting lungs
- Significant corneal disease
- Active tuberculosis infection
- Severe infection or recent antibiotic treatment before study start
- Incomplete recovery from major surgery or ongoing complications
- Psychiatric or substance abuse disorders interfering with trial participation
- Pregnancy, breastfeeding, or planning conception during study and specified post-treatment periods
- Female participants not using effective contraception or not post-menopausal/surgically sterile
- Male participants not using contraception or sterile during study and washout period
- History of allogenic tissue or solid organ transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 cycles of 3 weeks each for induction, followed by maintenance until disease progression or unacceptable toxicity
Participants 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 unacceptable toxicity or disease progression.
Visits every 3 weeks for medical evaluation and laboratory tests; imaging every 6 weeks during first 24 weeks, then every 9 weeks
Duration - Up to approximately 2 years or until study end
Participants undergo ongoing assessments including imaging and patient-reported outcomes during maintenance therapy and monitoring for disease progression or toxicity.
Imaging every 6 weeks for first 24 weeks, then every 9 weeks; patient questionnaires at baseline and during treatment
Trial Site Locations
Total: 1 location
1
FUNFARME - Hospital de Base de São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil, 15.090-000
Actively Recruiting
Research Team
P
Project Manager
L
Laura Voelcker
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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