Lung Cancer Clinical Trial
Multicenter Study of Rociletinib Administered to Patients With Previously Treated Mutant EGFR Non-small Cell Lung Cancer
Summary
The purpose of this study is to evaluate the safety and anti-tumor effect of rociletinib. The trial is open-ended, which means patients will continue to take rociletinib until the study doctor determines it is no longer beneficial for them.
Full Description
This is a Phase 2, single arm, open-label, dual cohort, multicenter study evaluating the safety and efficacy of rociletinib administered orally to patients with previously treated mutant EGFR NSCLC.
Patients will be enrolled into 2 cohorts. Cohort A will enroll approximately 125 eligible patients who are centrally confirmed T790M-positive. Cohort B will be a continuation of the study and will enroll up to approximately 100 eligible patients who will be either centrally confirmed T790M-positive or T790M-negative.
All patients (for Cohort A and B) should have experienced disease progression while on treatment with the first single-agent EGFR-directed TKI (EGFR-TKI) for advanced/metastatic NSCLC. One line of chemotherapy prior to the EGFR-TKI treatment is permissible.
The study (Cohorts A and B) will consist of a screening phase to establish study eligibility and document baseline measurements, an open-label treatment phase, in which the patient will receive rociletinib to ascertain safety and efficacy until disease progression as defined by RECIST Version 1.1, clinical tumor progression, or unacceptable toxicity as assessed by the investigator. For patients with clinical progression, radiographic assessment should be performed to document evidence of radiographic progression.
Eligibility Criteria
Inclusion Criteria
Histologically or cytologically confirmed metastatic or unresectable locally advanced NSCLC
Documented evidence of a tumor with 1 or more EGFR mutations excluding exon 20 insertion
Disease progression confirmed by radiologic assessment while receiving treatment with the first single agent EGFR-TKI
EGFR TKI treatment discontinued less than or equal to 30 days prior to planned initiation of rociletinib
The washout period for an EGFR inhibitor is a minimum of 3 days
No intervening treatment between cessation of single agent EGFR TKI and planned initiation of rociletinib
Previous treatment with less than or equal to 1 prior chemotherapy (excluding prior neo-adjuvant or adjuvant chemotherapy or chemoradiotherapy with curative intent)
Any toxicity related to prior EGFR inhibitor treatment must have resolved to Grade 1 or less
Central laboratory confirmation of the presence of the T790M mutation in tumor tissue in Cohort A and the presence or absence of the T790M mutation in tumor tissue in Cohort B. Centrally indeterminate, unknown or invalid specimens are not acceptable. Biopsy material obtained from either primary or metastatic tumor tissue and sent to the central laboratory must be within 60 prior to dosing study drug but following disease progression on the first EGFR TKI
Measurable disease according to RECIST Version 1.1
Life expectancy of at least 3 months
ECOG performance status of 0 to 1
Minimum Age 18 years (in certain territories, the minimum age requirement may be higher eg age 20 years in Japan and Taiwan)
Adequate hematological and biological function, confirmed by defined laboratory values
Written consent on an IRB/IEC-approved Informed Consent Form (ICF) prior to any study specific evaluation
Exclusion Criteria
Documented evidence of an exon 20 insertion activating mutation in the EGFR gene
Active second malignancy i.e. patient known to have potentially fatal cancer present for which he/she may be (but not necessarily) currently receiving treatment
Patients with a history of malignancy that has been completely treated, with no evidence of that cancer currently, are permitted to enrol in the trial provided all chemotherapy was completed greater than 6 months prior and/or bone marrow transplant greater than 2 years prior
Known pre-existing interstitial lung disease
Cohort A only: Patients with leptomeningeal carcinomatosis are excluded. Other central nervous system (CNS) metastases are only permitted if treated, asymptomatic, and stable (not requiring steroid for at least 4 weeks prior to the start of study treatment). Cohort B only: Patients with CNS metastases or leptomeningeal carcinomatosis are excluded.
Treatment with prohibited medications less than or equal to 14 days prior to treatment with rociletinib
Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication before starting rociletinib
Prior treatment with rociletinib, or other drugs that target T790M positive mutant EGFR with sparing of wild type EGFR
Any of the following cardiac abnormalities or history
Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia's method (QTCF) greater than 450 msec
Inability to measure QT interval on ECG
Personal or family history of long QT syndrome
Implantable pacemaker or implantable cardioverter defibrillator
Resting bradycardia less than 55 beats/min
Non-study related surgical procedures less than or equal to 7 days prior to administration of rociletinib. In all cases, the patient must be sufficiently recovered and stable before treatment administration
Females who are pregnant or breastfeeding
Refusal to use adequate contraception for fertile patients (females and males) while on treatment and for 12 weeks after the last dose of rociletinib
Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
Any other reason the investigator considers the patient should not participate in the study
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There are 78 Locations for this study
Alhambra California, 91801, United States
Bakersfield California, 93309, United States
Fullerton California, 92835, United States
La Jolla California, 92093, United States
Northridge California, 91328, United States
Redondo Beach California, 90277, United States
Sacramento California, 95817, United States
San Francisco California, 94115, United States
San Luis Obispo California, 93401, United States
Grand Junction Colorado, 81501, United States
Lone Tree Colorado, 80218, United States
New Haven Connecticut, 32135, United States
Miami Florida, 33176, United States
Weston Florida, 33331, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60612, United States
Niles Illinois, 60714, United States
Boston Massachusetts, 02215, United States
Burlington Massachusetts, 01805, United States
Minneapolis Minnesota, 55404, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
Bronx New York, 10461, United States
Latham New York, 12110, United States
Rochester New York, 14642, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Philadelphia Pennsylvania, 19111, United States
Nashville Tennessee, 37203, United States
Amarillo Texas, 79106, United States
Arlington Texas, 76014, United States
Austin Texas, 78705, United States
Beaumont Texas, 77702, United States
Bedford Texas, 76022, United States
Dallas Texas, 75246, United States
Flower Mound Texas, 75028, United States
Houston Texas, 77030, United States
Plano Texas, 75075, United States
Fairfax Virginia, 22031, United States
Vancouver Washington, 98686, United States
Yakima Washington, 98902, United States
South Brisbane New South Wales, 4101, Australia
Sydney New South Wales, 2065, Australia
Westmead New South Wales, 2145, Australia
Bedford Park South Australia, 5042, Australia
Toronto Ontario, M5G 2, Canada
Besançon Franche-comte, 25030, France
Paris Ile-de-france, 75020, France
Villejuif Ile-de-France, 94805, France
Saint Herblain cedex PAYS DE LA Loire, , France
Pierre Bénité cedex Rhone-alpes, 69495, France
Caen , , France
Marseille Cedex 20 , 13915, France
Gauting Bayern, 82131, Germany
München Bayern, 80336, Germany
Frankfurt am Main Hessen, 60590, Germany
Oldenburg Niedersachsen, 26121, Germany
Bonn Nordrhein-westfalen, 53127, Germany
Essen Nordrhein-westfalen, 45122, Germany
Köln Nordrhein-westfalen, 50937, Germany
Großhansdorf Schleswig-holstein, 22927, Germany
Berlin , 13125, Germany
Hong Kong , , Hong Kong
Chungju Chungcheongbuk-do, , Korea, Republic of
Goyang-si Gyeonggi-do, , Korea, Republic of
Incheon Gyeonggi-do, 405-7, Korea, Republic of
Busan , , Korea, Republic of
Incheon , 400-7, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Amsterdam Noord-holland, 1066 , Netherlands
Amsterdam , 1081 , Netherlands
Seville Sevilla, 41013, Spain
Badalona , , Spain
Barcelona , 08035, Spain
Barcelona , , Spain
Madrid , , Spain
Lausanne Vaud, 1011, Switzerland
Taipei Taipei CITY, 11217, Taiwan
Taoyuan Tao-Yuan, 33305, Taiwan
Taichung , 40447, Taiwan
Taichung , 40705, Taiwan
Taipei , 100, Taiwan
Cambridge England, CB2 0, United Kingdom
London Greater London, SE1 9, United Kingdom
London Greater London, SW3 6, United Kingdom
Sutton Surrey, SM2 5, United Kingdom
London , NW1 2, United Kingdom
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