Multicenter Study of Rociletinib Administered to Patients With Previously Treated Mutant EGFR Non-small Cell Lung Cancer

NCT ID: NCT02147990

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 318 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-16
• Study Completion Date: 2019-08-27

Brief 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.

Detailed 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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rociletinib Mono-Therapy, T790M +ve (625mg BID)

Starting dose of 625mg rociletinib, taken orally twice daily, with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Tablets should be swallowed whole. Treatment with rociletinib is continuous and each cycle will comprise of 28 days.

Group Type: EXPERIMENTAL

Rociletinib

Intervention Type: DRUG

Rociletinib will be administered to patients orally

Rociletinib Mono-Therapy, T790M +ve (500mg BID)

Starting dose of 500mg rociletinib, taken orally twice daily, with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Tablets should be swallowed whole. Treatment with rociletinib is continuous and each cycle will comprise of 28 days.

Group Type: EXPERIMENTAL

Rociletinib

Intervention Type: DRUG

Rociletinib will be administered to patients orally

Rociletinib Mono-Therapy, T790M -ve (500mg BID)

Starting dose of 500mg rociletinib, taken twice daily, with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Tablets should be swallowed whole. Treatment with rociletinib is continuous and each cycle will comprise of 28 days.

Group Type: EXPERIMENTAL

Rociletinib

Intervention Type: DRUG

Rociletinib will be administered to patients orally

Interventions

Rociletinib

Rociletinib will be administered to patients orally

Intervention Type: DRUG

Other Intervention Names

CO-1686

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clovis Oncology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UCLA Medical Center

Alhambra, California, United States

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

Saint Jude Heritage Healthcare

Fullerton, California, United States

University of California San Diego Moores Cancer Center

La Jolla, California, United States

Northridge Hospital Medical Center

Northridge, California, United States

Cancer Care Associates

Redondo Beach, California, United States

University of California Davis Medical Center

Sacramento, California, United States

University of California San Francisco

San Francisco, California, United States

Coastal Integrative Cancer Care

San Luis Obispo, California, United States

Saint Mary's Regional Cancer Center

Grand Junction, Colorado, United States

Rocky Mountain Cancer Centers, LLP

Lone Tree, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Advanced Medical Specialties

Miami, Florida, United States

Cleveland Clinic Florida

Weston, Florida, United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

University of Illinois Chicago

Chicago, Illinois, United States

Illinois Cancer Specialists

Niles, Illinois, United States

Beth Israel Comprehensive Cancer Center

Boston, Massachusetts, United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Minnesota Oncology Hematology, P.A

Minneapolis, Minnesota, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

New York Oncology Hematology, PC

Latham, New York, United States

University of Rochester

Rochester, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

University Hospitals of Cleveland

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Texas Oncology P.A.

Amarillo, Texas, United States

USO - Texas Oncology P.A.

Arlington, Texas, United States

Texas Oncology-Austin Central

Austin, Texas, United States

Texas Oncology-Beaumont

Beaumont, Texas, United States

Texas Oncology P.A.

Bedford, Texas, United States

Texas Oncology P.A.

Dallas, Texas, United States

Texas Oncology P.A.

Flower Mound, Texas, United States

The Methodist Hospital

Houston, Texas, United States

Texas Oncology - Plano East

Plano, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Northwest Cancer Specialists, P.C.

Vancouver, Washington, United States

Yakima Valley Memorial Hospital, North Star Lodge

Yakima, Washington, United States

Icon Cancer Centre

South Brisbane, New South Wales, Australia

Royal North Shore Hospital

Sydney, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Princess Margaret Hospital

Toronto, Ontario, Canada

Centre Hospitalier Lyon Sud

Pierre Bénité Cedex, Auvergne-Rhône-Alpes, France

Centre Hospitalier Regional Universitaire (CHRU) de Besancon - L'Hopital Jean Minjoz

Besançon, Franche-comte, France

Institut de Cancérologie de l'Ouest - René Gauducheau

Saint-Herblain, Pays de la Loire Region, France

Centre Hospitalier Universitaire Côte de Nacre

Caen, , France

Centre Hospitalier Universitaire Hôpital Nord

Marseille, , France

Hôpital Tenon

Paris, Île-de-France Region, France

Institut Gustave Roussy

Villejuif, Île-de-France Region, France

Asklepios Fachkliniken München-Gauting

Gauting, Bavaria, Germany

Klinikum Innenstadt LMU

München, Bavaria, Germany

Goethe-Universität Frankfurt am Main

Frankfurt am Main, Hesse, Germany

Pius Hospital Oldenburg

Oldenburg, Lower Saxony, Germany

Universitaetsklinikum Bonn - Zentrum fuer Innere Medizin - Medizinische Klinik und Poliklink III

Bonn, North Rhine-Westphalia, Germany

Universitätsklinikum Köln

Cologne, North Rhine-Westphalia, Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

LungenClinic Großhansdorf GmbH

Großhansdorf, Schleswig-Holstein, Germany

Evangelische Lungenklinik Berlin

Berlin, , Germany

Queen Mary Hospital

Hong Kong, , Hong Kong

Antoni van Leeuwenhoek Hospital

Amsterdam, North Holland, Netherlands

Vrije Universiteit Medisch Centrum

Amsterdam, , Netherlands

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Gachon University Gil Medical Center

Incheon, Gyeonggi-do, South Korea

Chungbuk National University Hospital

Chungju, North Chungcheong, South Korea

Dong-A University Hospital

Busan, , South Korea

Inha University Hospital

Incheon, , South Korea

Samsung Medical Center

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Seoul Saint Mary's Hospital

Seoul, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Hospital Universitario Virgen del Rocio

Seville, Sevilla, Spain

Hospital Universitari Germans Trias i Pujol

Badalona, , Spain

Hospital Vall d´Hebrón

Barcelona, , Spain

Hospital Universitario Quirón Dexeus

Barcelona, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Centre Hospitalier Universitaire Vaudoise

Lausanne, Canton of Vaud, Switzerland

Taipei Veterans General Hospital

Taipei, Taipei CITY, Taiwan

Chang Gung Memorial Hospital Linkou

Taoyuan District, Tao-Yuan, Taiwan

China Medical University Hospital

Taichung, , Taiwan

Taichung Veterans General Hospital

Taichung, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, United Kingdom

Guy's and Saint Thomas NHS Foundation Trust

London, Greater London, United Kingdom

Royal Marsden Hospital

London, Greater London, United Kingdom

Royal Marsden NHS Trust

Sutton, Surrey, United Kingdom

University College Hospital

London, , United Kingdom

Countries

United States; Australia; Canada; France; Germany; Hong Kong; Netherlands; South Korea; Spain; Switzerland; Taiwan; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CO-1686-019 (TIGER-2)

Identifier Type: -

Identifier Source: org_study_id