Actively Recruiting
A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastases From NSCLC (Non-small Cell Lung Cancer)
Led by Latin American Cooperative Oncology Group · Updated on 2025-09-29
46
Participants Needed
1
Research Sites
161 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
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. Patients with intracranial progression but no systemic progression may receive stereotactic radiosurgery and continue treatment based on the investigator's decision.
CONDITIONS
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older with histologically confirmed non-small cell lung cancer (NSCLC)
- Metastatic non-squamous NSCLC with PD-L1 tumor proportion score less than 50%
- Negative tests for EGFR, ALK, ROS1, NTRK, RET, HER2, and MET actionable mutations
- No prior systemic therapy for advanced or metastatic NSCLC (prior therapy for localized disease allowed if progression occurred at least 6 months after last treatment)
- Recovery to Grade 1 or baseline from adverse events of previous cancer treatments
- Written informed consent provided
- Measurable disease including one or more measurable brain metastases and extracranial lesions
- No neurological symptoms requiring immediate and significant intervention
- No leptomeningeal carcinomatosis
- Provided tumor tissue sample for testing
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Life expectancy greater than 12 weeks
- Adequate washout period from prior treatments
- If hepatitis B positive, on antiviral therapy with undetectable viral load
- If HIV positive, well-controlled HIV on stable antiretroviral therapy
- Negative pregnancy test for women of childbearing potential
- Adequate organ function based on blood tests within 10 days before starting treatment
You will not qualify if you...
- Previous systemic anti-cancer therapy or investigational agents within 4 weeks prior to study
- Recent brain or chest radiotherapy within specified time frames or ongoing radiation-related toxicities needing corticosteroids
- Live vaccination within 30 days before starting treatment
- Immunodeficiency or recent systemic immunosuppressive therapy above allowed doses
- Spinal cord compression
- Uncontrolled or significant cardiovascular disease
- Active additional cancers requiring treatment within past 5 years (with some exceptions)
- Severe hypersensitivity to study drugs or their components
- History or presence of interstitial lung disease or pneumonitis
- Severe pulmonary compromise or autoimmune lung disease
- Significant corneal disease
- Active tuberculosis infection
- Severe infections or antibiotic treatment close to study start
- Incomplete recovery from major surgery or ongoing complications
- Psychiatric or substance abuse disorders interfering with study participation
- Pregnancy, breastfeeding, or intent to conceive during and for months after study
- Inadequate contraception for participants of childbearing potential
- History of allogenic tissue or solid organ transplant
AI-Screening
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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
CONTACT
L
Laura Voelcker
CONTACT
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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