Lung Cancer Clinical Trial
Rociletinib (CO-1686) USA Expanded Access Program
Summary
To provide access to rociletinib for patients with advanced or metastatic EGFR-mutant NSCLC who have been treated previously with EGFR directed therapy and have evidence of a T790M mutation (T790M+).
Full Description
This is an open-label, multi-center study in the US, which allows for expanded access to rociletinib for patients with advanced or metastatic, EGFR-mutant T790M+ NSCLC who were previously treated with at least one prior EGFR TKI therapy (≥2nd line). Patients will receive oral rociletinib twice daily on study as long as they have clinical benefit and until they have access to FDA-approved rociletinib.
Eligibility Criteria
Key Inclusion Criteria:
Unresectable locally advanced or metastatic NSCLC with EGFR activating mutation (excluding exon 20 insertion) and presence of the T790M mutation
Prior treatment with an approved or experimental EGFR-directed therapy
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Adequate hematological and biological function
Written informed consent on an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved ICF before any study-specific evaluation
Key Exclusion Criteria:
Eligibility for other enrolling clinical trials of rociletinib
Leptomeningeal carcinomatosis or other untreated or symptomatic CNS metastases (asymptomatic CNS metastases allowed if clinically stable without requirement for steroid dose increase for at least 4 weeks)
History of prior interstitial lung disease
Concurrent use of QT-prolonging medication
Cardiac abnormalities:
Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia's method (QTcF) > 450 ms
Inability to measure QT interval on ECG
Personal or family history of long QT syndrome
Implantable pacemaker or implantable cardioverter defibrillator
Resting bradycardia < 55 beats/min
Presence of serious or unstable concomitant systemic disorder incompatible with the clinical study (eg, substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, symptomatic pulmonary embolism, and other active malignancy associated with life expectancy of less than 1 year)
Pregnant or breastfeeding females and male or female patients who refuse to use adequate contraception during the study and for 12 weeks after the last dose of rociletinib
Any contraindication, allergy, or hypersensitivity to rociletinib or excipients
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There are 11 Locations for this study
Scottsdale Arizona, 85024, United States
Fountain Valley California, 92866, United States
Monterey California, 93940, United States
Sacramento California, 95816, United States
San Francisco California, 94115, United States
Daytona Beach Florida, 32114, United States
Orlando Florida, 32806, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48202, United States
Billings Montana, 59101, United States
Tulsa Oklahoma, 74146, United States
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