Phase II non-randomized study of Atezolizumab (MPDL3280A) in combination with Carboplatin Plus Pemetrexed in patients who are chemotherapy-naïve and have stage IV non-squamous non-small cell lung cancer with asymptomatic brain metastases (ATEZO-BRAIN) - ATEZO-BRAI

Spanish Lung Cancer Group (SLCG/GECP)0 sites40 target enrollmentMay 21, 2018

Overview

No summary available.

Registry

who.int

Start Date

May 21, 2018

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Spanish Lung Cancer Group (SLCG/GECP)

•Patients must meet the following criteria for study entry:
•\- Signed Informed Consent Form
•\- Age \= 18 years at time of signing Informed Consent Form
•\- Ability to comply with the study protocol, in the investigator’s judgment
•\- ECOG Performance Status (PS) of 0 to 1
•\- Histologically or cytologically confirmed, Stage IV non\-squamous NSCLC; patients with mixed non\-small cell histology (i.e. squamous and non\-squamous) are eligible whether the major component appears to be non\-squamous
•\- No prior treatment or Stage IV non\-squamous NSCLC: Patients with a sensitizing mutation in EGFR gene are excluded given that EGFR TKIs are the appropriate front\-line treatment for those patients, patients with an ALK fusion are excluded given that ALK TKIs are the appropriate front\-line treatment for those patients, patients with unknown EGFR and ALK status require test results at screening, they can be assessed at a local or central laboratory
•\- 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

•Patients who meet any of the following criteria will be excluded from study entry:
•\- 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
•\- Patients harboring an EGFR mutation or an ALK fusion will be excluded
•\- 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