TIGER-1: Safety and Efficacy Study of Rociletinib (CO-1686) or Erlotinib in Patients With EGFR-mutant/Metastatic NSCLC Who Have Not Had Any Previous EGFR Directed Therapy

NCT02186301 | Terminated Phase 2 Results DMC

• 1 other identifier: CO-1686-022 (TIGER-1)
• Study Type: interventional
• Target: 100
• Locations: 7 countries
• Sites: 74

Brief Summary

The purpose of this study is to compare the safety and anti-tumor effect of rociletinib with erlotinib in patients whose tumors have specific EGFR mutations and who have not previously received any treatment for advanced/metastatic EGFR mutated NSCLC. This study is a 'Randomized' Study. This means that upon entering the study, patients will be randomly assigned to be dosed with either rociletinib twice a day or erlotinib once a day. Patients will continue to take either rociletinib or erlotinib until it is no longer beneficial.

Conditions

Non-Small Cell Lung Cancer

Keywords

cancer; metastatic; locally advanced; lung; non-small cell lung cancer; NSCLC; epidermal growth factor receptor; EGFR; T790M; CO-1686; unresectable; recurrent; EGFR-directed therapy; irreversible EGFR inhibitor; TIGER; rociletinib

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS)

  To compare the antitumor efficacy of oral single-agent rociletinib with that of erlotinib as measured by progression-free survival (PFS), when administered as a first-line targeted treatment to patients with EGFR-mutated, advanced NSCLC.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of one or more new lesions is also considered progression.

  Cycle 1 Day 1 to End of Treatment, up to approximately 35 months

Secondary Outcomes (2)

• Confirmed Response Rate

  Cycle 1 Day 1 to End of Treatment, up to approximately 35 months.

• Duration of Response

  Cycle 1 Day 1 to End of Treatment, up to approximately 35 months

Study Arms (2)

Erlotinib Mono-Therapy

ACTIVE COMPARATOR

Drug: Erlotinib Mono-Therapy

Rociletinib Mono-Therapy

EXPERIMENTAL

Drug: Rociletinib Mono-Therapy

Interventions

Rociletinib Mono-Therapy DRUG

Rociletinib will be administered twice daily

Rociletinib Mono-Therapy

Erlotinib Mono-Therapy DRUG

Erlotinib will be administered once a day

Erlotinib Mono-Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed metastatic or unresectable locally advanced/metastatic NSCLC
• Documented evidence of a tumor with activating EGFR mutations by local testing. Patients with exon 20 insertions are not eligible with the exception of patients with documented evidence of the exon 20 insertion A763\_Y764insFQEA in the EGFR gene
• Have undergone a biopsy or surgical resection of either primary or metastatic tumor tissue within 60 days of the first day of study treatment, C1D1, and have tissue available to send to sponsor laboratories or are able to undergo a biopsy during screening and provide tissue to sponsor laboratories
• Measureable disease according to RECIST Version 1.1
• Life expectancy of at least 3 months
• ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 1
• Minimum age 18 years (in certain territories, the minimum age requirement may be higher (e.g. 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

You may not qualify if:

• Documented evidence of an exon 20 insertion activating mutation other than A763\_Y764insFQEA in the EGFR gene
• Prior treatment with cytotoxic chemotherapy for advanced NSCLC; neoadjuvant/adjuvant chemotherapy is permitted if at least 6 months has elapsed between the end of chemotherapy and randomization
• 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, and currently with no evidence of that cancer, are permitted to enroll in the trial provided all chemotherapy was completed \> 6 months prior and/or bone marrow transplant \> 2 years prior to first day of study treatment
• Known pre-existing interstitial lung disease
• Brain metastases
• Treatment with prohibited medications less than or equal to 14 days prior to first day of study treatment
• Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval if that treatment cannot be either discontinued or switched to a different medication prior to administration of study drug
• Prior treatment with EGFR TKIs (e.g. erlotinib, gefitinib, neratinib, afatinib, AZD9291, or dacomitinib), rociletinib or other drugs that target mutant EGFR
• 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
• Non-study related surgical procedures less than or equal to 7 days prior to administration of study drug. In all cases, the patient must be sufficiently recovered and stable before treatment administration.

Sponsors & Collaborators

• Clovis Oncology, Inc.: lead

Study Sites (74)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

East Valley Hematology and Oncology Medical Group, Inc.

Burbank, California, 91505, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

Compassionate Cancer Care Medical Group, Inc.

Fountain Valley, California, 92708, United States

Location

St. Joseph Heritage Healthcare

Fullerton, California, 92835-3825, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093-0698, United States

Location

University of Southern California, Norris Comprehensive Cancer Center

Los Angeles, California, 90089, United States

Location

Sutter Medical Group

Sacramento, California, 95816, United States

Location

University of California San Francisco

San Francisco, California, 94115, United States

Location

Sansum Clinic

Santa Barbara, California, 93105, United States

Location

Central Coast Medical Oncology Corporation

Santa Maria, California, 93454, United States

Location

UCLA Medical Center

Santa Monica, California, 90404, United States

Location

The Oncology Institute of Hope and Innovation

Whittier, California, 90603, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Cancer Specialists of North Florida

Fleming Island, Florida, 32003, United States

Location

Florida Cancer Specialists and Research Institute

Fort Myers, Florida, 33916, United States

Location

Advanced Medical Specialties

Miami, Florida, 33176, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Florida Cancer Specialists

St. Petersburg, Florida, 33705, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Illinois Cancer Center

Chicago, Illinois, 60612, United States

Location

Illinois Cancer Specialists

Niles, Illinois, 60714, United States

Location

Harry and Jeanette Weinberg Cancer Institute at Franklin Square

Baltimore, Maryland, 21237, United States

Location

Walter Reed Army Institute of Research

Bethesda, Maryland, 20889, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Oncology Hematology West PC

Omaha, Nebraska, 68130, United States

Location

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, 89014, United States

Location

Regional Cancer Care Associates, LLC

East Brunswick, New Jersey, 08816, United States

Location

Regional Cancer Care Associates

Morristown, New Jersey, 07962, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Hollings Cancer Center

Charleston, South Carolina, 29425, United States

Location

Tennessee Oncology, PLLC

Chattanooga, Tennessee, 37404, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

USC/Norris Comprehensive Cancer Center

Nashville, Tennessee, 37212-3505, United States

Location

Texas Oncology, PA

Austin, Texas, 78745, United States

Location

Texas Oncology-Beaumont

Beaumont, Texas, 77702, United States

Location

Texas Oncology, P.A.

Bedford, Texas, 76022, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-8852, United States

Location

Houston Methodist Cancer Center

Houston, Texas, 77030, United States

Location

The University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Texas Oncology-Plano East

Plano, Texas, 75075-7753, United States

Location

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

Northwest Cancer Specialists, P.C.

Vancouver, Washington, 98684, United States

Location

Yakima Valley Memorial Hospital, North Star Lodge

Yakima, Washington, 98902, United States

Location

Asklepios Fachkliniken München-Gauting

Gauting, Bavaria, 82131, Germany

Location

Pius Hospital Oldenburg

Oldenburg, Lower Saxony, 26121, Germany

Location

Universitätsklinikum Köln

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Katholisches Klinikum Mainz, Sankt Hildegardis-Krankenhaus

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Evangelische Lungenklinik Berlin

Berlin, Germany

Location

Prince of Wales Hospital

Hong Kong, New Territories, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Ospedale Civile di Livorno

Livorno, 57124, Italy

Location

Dong-A University Hospital

Busan, 602-715, South Korea

Location

Inha University Hospital

Incheon, 400-711, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 463-707, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

The Catholic University of Korea Saint Vincent's Hospital

Suwon, 442-723, South Korea

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Chang Gung Memorial Hospital Linkou

Taoyuan District, 33305, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms; Neoplasm Metastasis; Recurrence

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Results Point of Contact

• Title: Vi Nguyen
• Organization: Clovis Oncology

vnguyen@clovisoncology.com

+1 415 915 9982

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: July 10, 2014
• Study Start: November 1, 2014
• Primary Completion: June 28, 2017
• Study Completion: June 28, 2017
• Last Updated: May 7, 2019
• Results First Posted: April 30, 2019

Record last verified: 2019-04

Locations

US (54); DE (5); IT (1); KR (7); ES (2); TW (3); HK (2)