Rociletinib (CO-1686) USA Expanded Access Program

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.

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