Suspended

An Expanded Access Protocol of Oral Rociletinib (CO-1686) as Epidermal Growth Factor Receptor (EGFR)-Directed Therapy for Patients With EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC) With the T790M Resistance Mutation

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is eligible

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

Over 18 Years
See all eligibility criteria
How is it accessible

Suspended

Available upon a request by a licensed MD
Expanded Access
See protocol details

Summary

Principal SponsorClovis Oncology, Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleAn Expanded Access Protocol of Oral Rociletinib (CO-1686) as Epidermal Growth Factor Receptor (EGFR)-Directed Therapy for Patients With EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC) With the T790M Resistance Mutation
NCT02547675
Principal SponsorClovis Oncology, Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 11 locations

Suspended

Mayo Clinic Arizona

Scottsdale, United StatesOpen Mayo Clinic Arizona in Google Maps
Suspended

Compassionate Care Research Group, Inc.

Fountain Valley, United States
Suspended

Pacific Cancer Care

Monterey, United States
Suspended

Sutter Cancer Institute

Sacramento, United States
Suspended11 Study Centers