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Non-Small Cell Lung CancerPhase 2/3EGFRNCT02186301

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

A Phase 2/3 study testing Rociletinib Mono-Therapy and Erlotinib Mono-Therapy in people with Non-Small Cell Lung Cancer, run by Clovis Oncology, Inc. at 74 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Rociletinib Mono-Therapy and Erlotinib Mono-Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
74 sitesin 7 countries
Study dates
Nov 2014to 28 Jun 2017
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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.
  • Females who are pregnant or breastfeeding
  • Refusal to use adequate contraception for fertile patients (females and males) for 12 weeks after the last dose of rociletinib and 2 weeks after the last dose of erlotinib
  • 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

Trial locations and contacts

74 sites in 7 countries.

74 sites in 7 countries

United States54 sites

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • Texas Oncology, PA

    Austin, Texas, 78745

  • Harry and Jeanette Weinberg Cancer Institute at Franklin Square

    Baltimore, Maryland, 21237

  • Texas Oncology-Beaumont

    Beaumont, Texas, 77702

  • Texas Oncology, P.A.

    Bedford, Texas, 76022

  • Walter Reed Army Institute of Research

    Bethesda, Maryland, 20889

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • East Valley Hematology and Oncology Medical Group, Inc.

    Burbank, California, 91505

  • Hollings Cancer Center

    Charleston, South Carolina, 29425

  • Tennessee Oncology, PLLC

    Chattanooga, Tennessee, 37404

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-8852

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • City of Hope

    Duarte, California, 91010

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Regional Cancer Care Associates, LLC

    East Brunswick, New Jersey, 08816

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Cancer Specialists of North Florida

    Fleming Island, Florida, 32003

  • Florida Cancer Specialists and Research Institute

    Fort Myers, Florida, 33916

  • Compassionate Cancer Care Medical Group, Inc.

    Fountain Valley, California, 92708

  • St. Joseph Heritage Healthcare

    Fullerton, California, 92835-3825

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89014

  • Houston Methodist Cancer Center

    Houston, Texas, 77030

  • The University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093-0698

  • University of Southern California, Norris Comprehensive Cancer Center

    Los Angeles, California, 90089

  • Advanced Medical Specialties

    Miami, Florida, 33176

  • Regional Cancer Care Associates

    Morristown, New Jersey, 07962

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • USC/Norris Comprehensive Cancer Center

    Nashville, Tennessee, 37212-3505

  • Illinois Cancer Specialists

    Niles, Illinois, 60714

  • Oncology Hematology West PC

    Omaha, Nebraska, 68130

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Texas Oncology-Plano East

    Plano, Texas, 75075-7753

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Sutter Medical Group

    Sacramento, California, 95816

  • University of California San Francisco

    San Francisco, California, 94115

  • Sansum Clinic

    Santa Barbara, California, 93105

  • Central Coast Medical Oncology Corporation

    Santa Maria, California, 93454

  • UCLA Medical Center

    Santa Monica, California, 90404

  • University of Washington

    Seattle, Washington, 98109

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Northwest Cancer Specialists, P.C.

    Vancouver, Washington, 98684

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Cleveland Clinic Florida

    Weston, Florida, 33331

  • The Oncology Institute of Hope and Innovation

    Whittier, California, 90603

  • Yakima Valley Memorial Hospital, North Star Lodge

    Yakima, Washington, 98902

Other trials in United States

South Korea7 sites

  • Dong-A University Hospital

    Busan, 602-715

  • Inha University Hospital

    Incheon, 400-711

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707

  • Severance Hospital, Yonsei University Health System

    Seoul, 120-752

  • Samsung Medical Center

    Seoul, 135-710

  • Asan Medical Center

    Seoul, 138-736

  • The Catholic University of Korea Saint Vincent's Hospital

    Suwon, 442-723

Other trials in South Korea

Germany5 sites

  • Evangelische Lungenklinik Berlin

    Berlin

  • Universitätsklinikum Köln

    Cologne, North Rhine-Westphalia, 50937

  • Asklepios Fachkliniken München-Gauting

    Gauting, Bavaria, 82131

  • Katholisches Klinikum Mainz, Sankt Hildegardis-Krankenhaus

    Mainz, Rhineland-Palatinate, 55131

  • Pius Hospital Oldenburg

    Oldenburg, Lower Saxony, 26121

Other trials in Germany

Taiwan3 sites

  • Taichung Veterans General Hospital

    Taichung, 40705

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Memorial Hospital Linkou

    Taoyuan, 33305

Other trials in Taiwan

Hong Kong2 sites

  • Prince of Wales Hospital

    Hong Kong, New Territories

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

Spain2 sites

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

Other trials in Spain

Italy1 site

  • Ospedale Civile di Livorno

    Livorno, 57124

Other trials in Italy

About this study

Official title: TIGER 1: A Randomized, Open-Label, Phase 2/3 Study of CO-1686 or Erlotinib as First-Line Treatment of Patients With EGFR-Mutant Advanced/Metastatic NSCLC

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.

Read the detailed description

This is a randomized, Phase 2/3 study of rociletinib versus erlotinib as a first-line treatment for patients with EGFR-mutant advanced/metastatic NSCLC whose tumors have EGFR-activating mutations. The study will consist of Phase 2 and Phase 3 parts which will use the same enrollment criteria and treatment assignment principles. Patients will be randomized 1:1 to erlotinib or rociletinib. The Phase 2 part is an open-label study. In the Phase 3 part, the sponsor will be blinded to the efficacy and safety results. The study will consist of a screening phase to establish study eligibility (including tumor genotype) and document baseline measurements, a treatment phase, in which patients will receive either rociletinib BID (twice a day) or erlotinib QD (once daily) to ascertain safety and efficacy until protocol-defined disease progression, and a follow-up phase, to monitor survival status and subsequent NSCLC cancer therapy. In the Phase 2 part only, patients initially randomized to erlotinib may be eligible to participate in an optional crossover phase to receive rociletinib if they demonstrate the T790M resistance mutation after radiographic progression on erlotinib treatment among other eligibility requirements. Patients eligible for this study must have EGFR-mutated NSCLC who have not been treated with an EGFR-directed therapy.Treatment with rociletinib or erlotinib is continuous. Each 28 day period of treatment will represent one cycle, with dosing initiated on Cycle 1 Day 1 (C1 D1).

Being tested
Rociletinib Mono-Therapy, Erlotinib Mono-Therapy
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
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasms, Neoplasm Metastasis, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rociletinib Mono-TherapyDrug

    Rociletinib will be administered twice daily

  • Erlotinib Mono-TherapyDrug

    Erlotinib will be administered once a day

Study groups in NCT02186301
Study groupRoleWhat they receive
Erlotinib Mono-TherapyActive comparatorNot described
Receives: Drug: Erlotinib Mono-Therapy
Rociletinib Mono-TherapyExperimentalNot described
Receives: Drug: Rociletinib Mono-Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)

  1. Confirmed Response Rate

    Proportion of patients with a best overall confirmed response of partial response (PR) or complete response (CR) recorded from the start of the treatment until disease progression or recurrence.

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as:

    Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

    Partial Response (PR),at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.

    Overall Response (OR),is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment was dependent on the achievement of both measurement and confirmation criteria.

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

  2. Duration of Response

    Duration of Response in Patients with Confirmed Response per Investigator

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2014 (estimated)
  2. Study startNov 2014
  3. Primary completion28 Jun 2017
  4. Study completion28 Jun 2017

Why it stopped: Sponsor discontinued development of CO-1686 for NSCLC

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02186301
Sponsor's protocol ID
CO-1686-022 (TIGER-1)
Acronym
EGFR
Status last verified
Apr 2019
First submitted
30 Jun 2014
Last updated
7 May 2019
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Rociletinib Mono-Therapy and Erlotinib Mono-Therapy in people with Non-Small Cell Lung Cancer, run by Clovis Oncology, Inc. at 74 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, South Korea, Germany, Taiwan, Hong Kong and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS) (time frame: Cycle 1 Day 1 to End of Treatment, up to approximately 35 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02186301.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2019.

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