Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03526900 : Atezolizumab in Combination With Carboplatin Plus Pemetrexed in Chemotherapy-naïve Patients With Asymptomatic Brain Metastasis
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Patients aged 18 years or older.

- Signed written informed consent.

- ECOG Performance Status (PS) of 0 to 1.

- Subjects with histologically or cytologically confirmed stage IV non-squamous NSCLC
who did not received any prior chemotherapy or brain radiotherapy. Patients with EGFR
mutation or ALK fusion will be excluded.

- Patients who received prior neo-adjuvant, adjuvant chemotherapy or chemoradiotherapy
with curative intent for non-metastatic disease must have experienced a treatment-free
interval of at least 6 months since the last dose of chemotherapy and/or radiotherapy.

- Asymptomatic untreated brain metastases. Steroids treatment (dexamethasone) is allowed
and patients that remained asymptomatic for 2 weeks on steroids will be eligible when
they were receiving = 4mg dexamethasone once a day.

- Systemic measurable disease by computed tomography (CT) per response evaluation
criteria in solid tumors version (RECIST) 1.1 criteria AND brain measurable disease by
magnetic resonance imaging (MRI) per RANO-BM criteria (at least two measurable lesions
=10mm, see appendix).

- Availability of a formalin-fixed paraffin-embedded block containing tumor tissue or 5
unstained slides

- Adequate hematopoietic, hepatic and renal function (including calculated creatinine
clearance of 45 ml/min based on the standard Cockcroft and Gault formula).

- Patients willing to use highly effective (<1% failure rate) forms of contraception.

Exclusion Criteria:

- History of other malignancy within 3 years prior to screening, except for
appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or
Stage I uterine cancer

- Known activating EGFR mutation or ALK fusion

- Leptomeningeal carcinomatosis or metastases in the brain stem, mid-brain, pons,
medulla or lesions causing obstructive hydrocephalus

- Patients with neurological symptoms, including those receiving > 4mg of dexamethasone
will not be eligible for this study

- Single exclusive brain metastasis amenable to surgical treatment or radiosurgery in
patients not having metastasis in other organ

- Spinal hemorrhagic metastases will be excluded

- Prior surgical resection of brain or spinal lesions in the prior 28 days

- Previous systemic treatment or neo-adjuvant or adjuvant chemotherapy less than 6
months before enrollment

- Clinical significant comorbidities that impaired administration of platinum-based
chemotherapy

- History of autoimmune disease

- Active severe infection

- History of idiopathic pulmonary fibrosis, drug-induced pneumonitis or radiation
pneumonitis out of the radiation field

- Positive test for HIV, hepatitis B or hepatitis C

- Previous treatment with immune checkpoint inhibitors or agonists (e.g. CD137 and
OX-40)

- Pregnancy or breast-feeding
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03526900      |      Link to official Clinicaltrials.gov listing
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