Clinical trial · Interventional
Pembro+Chemo in Brain Mets
Phase II Investigation of Use of CNS Active Pembrolizumab and Chemotherapy for Asymptomatic Brain Metastasis From Non-small Cell Lung Cancer (NSCLC)
NCT04964960CI-TRIAL-00096905terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow Accrual
Summary
Brief summary (as posted)
The goal of this study is to evaluate whether providing Pembrolizumab prolongs survival and preserves quality of life while minimizing side effects for patients with NSCLC with untreated asymptomatic brain metastasis.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Cancer | Malignant Brain Neoplasm | ALIAS | 0.90 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Nab paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pembrolizumab with standard of care chemotherapy treatment
- description
- Patients will receive 200mg or 400mg of Pembrolizumab (standard of care dosing at the discretion of treating physician) over thirty minutes on day 1 every three or six weeks with standard of care chemotherapy treatment (carboplatin, pemetrexed, paclitaxel, nab-paclitaxel).
- interventionNames
- Drug: Pembrolizumab
- Drug: Nab paclitaxel
- Drug: Paclitaxel
- Drug: Pemetrexed
- Drug: Carboplatin
Primary outcomes (1)
- measure
- Disease Control Rate
- timeFrame
- 6 months (baseline to 6 months)
- description
- Intracranial benefit defined as stable disease, partial response, and complete response
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Non-small cell lunch cancer (NSLC) with untreated asymptomatic brain metastases * NSLC lacks oncogenic driver mutations * Absence of new onset neurological symptoms * Presence of fewer than ten intracranial lesions * Each lesion measures three centimeters or less * Life expectancy of greater than three months * Adequate organ and marrow function * Ability to understand and willingness to sign a written informed consent document Exclusion Criteria: * Presence of oncogenic driver mutations * Measurable lesion located within 10mm of the optic chiasm or optic nerve, or within the brainstem * Known leptomeningeal involvement. * Midline shift * Serious non-healing wound, ulcer or bone fracture * Baseline inability to participate or complete neurocognitive testing * Major surgical procedure (including craniotomy and open brain biopsy) or significant traumatic injury within 14 days prior to registration * Receipt of a non-CNS minor surgical procedure (e.g. core biopsy or fine needle aspiration) within three days prior to registration * History of allergic reactions attributed to monoclonal antibodies (mAb), compounds of similar chemical or biologic composition to Pembrolizumab * Clinically significant cardiovascular disease * Patients with uncontrolled intercurrent illness * Patients with psychiatric illness/social situations that would limit compliance with study requirements
References
Publications (0)
Data not yet available
No reference posted for this study.