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A Trial of TAK-788 (AP32788) in Non-small Cell Lung Cancer (NSCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02716116
Recruitment Status : Recruiting
First Posted : March 23, 2016
Last Update Posted : September 5, 2019
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Brief Summary:
The purpose of this phase 1/2 study is to evaluate the safety, recommended phase 2 dose (RP2D), dose limiting toxicities (DLTs), maximum tolerated dose (MTD), pharmacokinetics of oral TAK-788 and its active metabolites, anti-tumor activity of TAK-788 in participants with NSCLC with epidermal growth factor receptor (EGFR) or human epidermal growth factor 2 (HER2) mutations, and anti-tumor activity of TAK-788 in participants with solid tumors other than NSCLC with EGFR or HER2 mutations, and to explore relationship between tumor and/or plasma biomarkers, and TAK-788 efficacy, safety, and/or cytochrome P450 3A (CYP3A) induction. The study will also determine the efficacy of TAK-788 in participants with locally advanced or metastatic NSCLC harboring EGFR in-frame exon 20 insertion mutations who have received at least 1 prior line of therapy for locally advanced or metastatic NSCLC.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: TAK-788 Phase 1 Phase 2

Detailed Description:

This phase 1/2 study will evaluate the safety, pharmacokinetics, and anti-tumor activity of oral EGFR/HER2 Inhibitor TAK-788 in participants with NSCLC and anti-tumor activity of TAK-788 in participants with solid tumors other than NSCLC with EGFR or HER2 mutations. The trial will be conducted in three parts: a dose escalation and expansion phase, followed by an extension phase.

The objectives of the dose escalation phase are to determine the safety profile of orally administered TAK-788, including the MTD, DLTs, RP2D and pharmacokinetic profile. The primary goal of the expansion component of the trial is to evaluate the anti-tumor activity of TAK-788 in seven histologically and molecularly defined cohorts at the RP2D (determined based on dose escalation phase of the trial).

The seven expansion cohorts will be:

  1. NSCLC participants with EGFR exon 20 activating insertions, who have either not received or not shown an objective response to an EGFR TKI, and who have no active, measurable CNS metastases;
  2. NSCLC participants with HER2 exon 20 activating insertions or point mutations and no active, measurable CNS metastases;
  3. NSCLC participants with EGFR exon 20 activating insertions or HER2 exon 20 activating insertions or point mutations and active, measurable CNS metastases;
  4. NSCLC participants with other targets against which TAK-788 is active (examples include EGFR exon 19 deletions or exon 21 substitutions [with or without T790M mutations] and other uncommon EGFR activating mutations), without active CNS metastases;
  5. NSCLC participants with EGFR exon 20 activating insertions, who have previously shown an objective response to an EGFR TKI and subsequently progressed, without active CNS metastases;
  6. NSCLC participants with EGFR exon 20 activating insertions, who have not received prior systemic anticancer treatment for locally advanced or metastatic disease, without active CNS metastases; and
  7. Participants with solid tumors other than NSCLC with EGFR/HER2 mutations against which TAK-788 is active, without active CNS metastases.

The extension phase will evaluate efficacy of TAK-788 in participants with locally advanced or metastatic NSCLC whose tumors harbor EGFR exon 20 insertion mutations and who have been previously treated. The study will enroll approximately 341 participants.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 341 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of the Oral EGFR/HER2 Inhibitor TAK-788 (AP32788) in Non-Small Cell Lung Cancer
Actual Study Start Date : April 30, 2016
Estimated Primary Completion Date : January 28, 2020
Estimated Study Completion Date : January 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose Escalation Cohort
TAK-788 treatment for participants with advanced NSCLC.
Drug: TAK-788
TAK-788 capsules.
Other Name: AP32788

Experimental: Expansion Cohort 1
TAK-788 treatment for NSCLC participants with EGFR exon 20 activating insertions, who have either not received or not shown an objective response to an EGFR tyrosine kinase inhibitors (TKI), and who have no active, measurable central nervous system (CNS) metastases.
Drug: TAK-788
TAK-788 capsules.
Other Name: AP32788

Experimental: Expansion Cohort 2
TAK-788 treatment for NSCLC participants with HER2 exon 20 activating insertions or point mutations and no active, measurable CNS metastases.
Drug: TAK-788
TAK-788 capsules.
Other Name: AP32788

Experimental: Expansion Cohort 3
TAK-788 treatment for NSCLC participants with EGFR exon 20 activating insertions or HER2 exon 20 activating insertions or point mutations and active, measurable CNS metastases.
Drug: TAK-788
TAK-788 capsules.
Other Name: AP32788

Experimental: Expansion Cohort 4
TAK-788 treatment for NSCLC participants with other targets against which TAK-788 is active (examples include EGFR exon 19 deletions or exon 21 substitutions [with or without T790M mutations] and other uncommon EGFR activating mutations), without active CNS metastases.
Drug: TAK-788
TAK-788 capsules.
Other Name: AP32788

Experimental: Expansion Cohort 5
TAK-788 treatment for NSCLC participants with EGFR exon 20 activating insertions, who have previously shown an objective response to an EGFR TKI and subsequently progressed without active CNS metastases.
Drug: TAK-788
TAK-788 capsules.
Other Name: AP32788

Experimental: Expansion Cohort 6
TAK-788 treatment NSCLC participants with EGFR exon 20 activating insertions, who have not received prior systemic anticancer treatment for locally advanced or metastatic disease without active CNS metastases
Drug: TAK-788
TAK-788 capsules.
Other Name: AP32788

Experimental: Expansion Cohort 7
TAK-788 treatment for participants with solid tumors other than NSCLC with EGFR/HER2 mutations against which TAK-788 is active without active CNS metastases.
Drug: TAK-788
TAK-788 capsules.
Other Name: AP32788

Experimental: Extension Cohort
TAK-788 treatment for participants with previously treated locally advanced or metastatic NSCLC whose tumors harbor EGFR exon 20 insertion mutations.
Drug: TAK-788
TAK-788 capsules.
Other Name: AP32788




Primary Outcome Measures :
  1. Dose Escalation Cohort: RP2D of Orally Administered TAK-788 [ Time Frame: Day 1 to 28 (Cycle 1) ]
  2. Expansion Cohorts 1, 2, 4, 5 and 7: Confirmed Objective Response Rate (ORR) Assessed by the Investigator [ Time Frame: up to 36 months after first dose ]
  3. Expansion Cohort 3: Intracranial ORR (iORR) Assessed by Independent Review Committee (IRC) [ Time Frame: up to 36 months after first dose ]
  4. Extension Cohort: Confirmed ORR Assessed by IRC [ Time Frame: up to 36 months after first dose ]
  5. Expansion Cohort 6: Confirmed ORR Assessed by IRC [ Time Frame: up to 36 months after first dose ]

Secondary Outcome Measures :
  1. Dose Escalation and Expansion Cohorts: Safety Analysis of TAK-788 Assessed by Adverse Events, Toxicity Grades, and Laboratory Test Results [ Time Frame: up to 36 months after first dose ]
  2. Dose Escalation Cohort: Identify DLTs and MTD of TAK-788 [ Time Frame: Day 1 to 28 in Cycle 1 (Cycle length is equal to [=] 28 days) ]
  3. Dose Escalation and Expansion Cohorts: Tmax: Time of First Occurrence of Maximum Plasma Concentration (Cmax) of TAK-788 and its Active Metabolite [ Time Frame: Cycle 1 Day 1 and Cycle 2 Day 1 (cycle length=28 days) ]
  4. Dose Escalation and Expansion Cohorts: AUC(0-24): Area Under the Concentration-time Curve from Time Zero to 24 hours for TAK-788 and its Active Metabolites [ Time Frame: Cycle 1 Day 1 and Cycle 2 Day 1 (cycle length=28 days) ]
  5. Dose Escalation and Expansion Cohorts: AUCt: Area Under the Concentration-time Curve from Time Zero to Time t for TAK-788 and its Active Metabolites [ Time Frame: Cycle 1 Day 1 and Cycle 2 Day 1 (cycle length=28 days) ]
  6. Dose Escalation and Expansion Cohorts: RAC (Cmax): Accumulation Ratio Based on Cmax of TAK-788 and its Active Metabolites [ Time Frame: Cycle 1 Day 1 and Cycle 2 Day 1 (cycle length=28 days) ]
  7. Dose Escalation and Expansion Cohorts: Ctrough: Observed Concentration at the end of a Dosing Interval of TAK-788 and its Active Metabolites [ Time Frame: Cycle 1 Day 1 and Cycle 2 Day 1 (cycle length=28 days) ]
  8. Dose Escalation and Expansion Cohorts: RAC (AUC): Accumulation Ratio Based on AUC of TAK-788 and its Active Metabolites [ Time Frame: Cycle 1 Day 1 and Cycle 2 Day 1 (cycle length=28 days) ]
  9. Dose Escalation and Expansion Cohorts: Cmax: Maximum Observed Concentration of TAK-788 and its Active Metabolites [ Time Frame: Cycle 1 Day 1 and Cycle 2 Day 1 (cycle length=28 days) ]
  10. Expansion Cohorts 1, 2, 3, 4, 5, and 7: Confirmed ORR as Assessed by IRC [ Time Frame: up to 36 months after first dose ]
  11. Expansion Cohorts: Best Overall Response as Assessed by the Investigator and IRC [ Time Frame: up to 36 months after first dose ]
  12. Expansion Cohorts: Best Target Lesion Response as Assessed by the Investigator and IRC [ Time Frame: up to 36 months after first dose ]
  13. Expansion and Extension Cohorts: Duration of Response as Assessed by the Investigator and IRC [ Time Frame: up to 36 months after first dose ]
  14. Expansion and Extension Cohorts: Time to Response as Assessed by the Investigator and IRC [ Time Frame: up to 36 months after first dose ]
  15. Expansion Cohort 3: Duration of Intracranial Response (iDOR) [ Time Frame: up to 36 months after first dose ]
  16. Expansion and Extension Cohorts: Disease Control Rate (DCR) as Assessed by the Investigator and IRC [ Time Frame: up to 36 months after first dose ]
  17. Expansion and Extension Cohorts: Progression Free Survival (PFS) as Assessed by the Investigator and IRC [ Time Frame: up to 36 months after first dose ]
  18. Expansion Cohort 3: Intracranial PFS (iPFS) [ Time Frame: up to 36 months after first dose ]
  19. Expansion and Extension Cohorts: Overall Survival (OS) [ Time Frame: up to 36 months after first dose ]
  20. Extension Cohort: Confirmed ORR as Assessed by the Investigator [ Time Frame: up to 36 months after first dose ]
  21. Dose Escalation and Expansion Cohorts: Cmax: Dose Linearity for TAK-788 Exposure [ Time Frame: Cycle 1 Day 1 and Cycle 2 Day 1 (cycle length=28 days) ]
  22. Dose Escalation and Expansion Cohorts: AUC: Dose Linearity for TAK-788 Exposure [ Time Frame: Cycle 1 Day 1 and Cycle 2 Day 1 (cycle length=28 days) ]
  23. Number of Participants With Patient-reported Symptoms (Lung Cancer), Functioning, and Health-related Quality of Life (HRQoL) Based on European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-core 30 (EORTC QLQ-C30) [ Time Frame: up to 30 days after last dose of drug (approximately up to 37 months) ]
  24. Number of Participants With Patient-reported Symptoms (Lung Cancer), Functioning, and health-related Global Quality of Life (HRQoL) Based on Quality of Life Questionnaire Lung Cancer Module-13 (QLQ-LC13) [ Time Frame: up to 30 days after last dose of drug (approximately up to 37 months) ]
  25. Expansion Cohorts 6: Confirmed ORR as Assessed by the Investigator [ Time Frame: up to 36 months after first dose ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria (all cohorts: dose escalation, expansion and extension):

  1. Have histologically or cytologically confirmed locally advanced (and not a candidate for definitive therapy) or metastatic disease (Stage IIIB or IV). For all cohorts except Expansion Cohort 7, the locally advanced or metastatic disease is NSCLC. For Expansion Cohort 7, the locally advanced or metastatic disease is any solid tumor other than NSCLC.
  2. Must have sufficient tumor tissue available for analysis. For participants in the expansion cohorts and in the extension cohort, tumor tissue obtained after progression on the most recent prior therapy is preferred.
  3. Must have measurable disease by response evaluation criteria in solid tumors (RECIST) v1.1.
  4. Male or female adult participants (aged 18 years or older, or as defined per local regulations).
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
  6. Minimum life expectancy of 3 months or more.
  7. Adequate organ function at baseline.
  8. Normal QT interval on screening electrocardiogram (ECG), defined as QT interval corrected (Fridericia) (QTcF) of less than or equal to (<=) 450 millisecond (ms) in males or <=470 ms in females.
  9. Willingness and ability to comply with scheduled visits and study procedures.

Part 1: Dose Escalation Cohort Specific Inclusion Criteria:

1. Refractory to standard available therapies.

Part 2: Expansion Cohort 1 Specific Inclusion Criteria:

  1. Have a documented EGFR in-frame exon 20 insertion by a local test.
  2. Previously treated with one or more regimens of systemic therapy for locally advanced or metastatic disease.
  3. Prior treatment with an EGFR TKI is allowed unless the participants had an objective response and subsequent progression as assessed by the investigator or treating physician during treatment with that prior TKI.

Expansion Cohort 2 Specific Inclusion Criteria:

  1. Have one of the following documented by a local test:

    1. A HER2 exon 20 insertion;
    2. An activating point mutation in HER2.
  2. Previously treated with one or more regimens of systemic therapy for locally advanced or metastatic disease.
  3. Prior treatment with a pan-HER TKI (example, afatinib, neratinib, or dacomitinib) is allowed unless the participants had an objective response and subsequent progression as assessed by the investigator or treating physician during treatment with that prior TKI.

Part 2: Expansion Cohort 3 Specific Inclusion Criteria:

  1. Have one of the following documented by a local test:

    1. An EGFR exon 20 insertion;
    2. A HER2 exon 20 insertion;
    3. An activating point mutation in HER2.
  2. Previously treated with one or more regimen of systemic therapy for locally advanced or metastatic disease.
  3. For participants with an EGFR exon 20 insertion: prior treatment with an EGFR TKI is allowed unless the participants had an objective response and subsequent progression as assessed by the investigator or treating physician during treatment with that prior TKI.
  4. For participants with a HER2 exon 20 insertion or HER2 activating point mutation: prior treatment with a pan-HER TKI (example, afatinib, neratinib, or dacomitinib) is allowed unless the participants had an objective response and subsequent progression as assessed by the investigator or treating physician during treatment with that prior TKI.
  5. Have either previously untreated intracranial CNS metastases or previously treated intracranial CNS metastases with radiologically documented new or progressing CNS lesions.
  6. Have at least one target (that is, measurable) intracranial CNS lesion (>=10 millimeter [mm] in longest diameter by contrast enhanced magnetic resonance imaging [MRI]).

Part 2: Expansion Cohort 4 Specific Inclusion Criteria:

  1. Have one of the following documented by a local test: an activating mutation in EGFR including exon 19 deletions or exon 21 L858R substitution (with or without T790M), or an uncommon activating mutation other than exon 20 insertion including, but not limited to, G719X (where X is any other amino acid), S768I, L861Q, or L861R.
  2. Treatment naive for locally advanced or metastatic disease or previously treated with one or more regimens of systemic therapy for locally advanced or metastatic disease.

Part 2: Expansion Cohort 5 Specific Inclusion Criteria:

NSCLC participants with EGFR exon 20 activating insertions, who have previously shown an objective response to an EGFR TKI and subsequently progressed, without active CNS metastases.

  1. Have a documented EGFR in-frame exon 20 insertion by a local test.
  2. Previously treated with one or more regimens of systemic therapy for locally advanced or metastatic disease.
  3. Previously showed an objective response to an EGFR TKI, then subsequently progressed as assessed by the investigator or treating physician.

Part 2: Expansion Cohort 6 Specific Inclusion Criteria:

NSCLC participants with EGFR exon 20 activating insertions, who have not received prior systemic anticancer treatment for locally advanced or metastatic disease, without active CNS metastases.

  1. Have a documented EGFR in-frame exon 20 insertion by a local test.
  2. No prior systemic treatment for locally advanced or metastatic disease.

Part 2: Expansion Cohort 7 Specific Inclusion Criteria:

Participants with solid tumors other than NSCLC with EGFR/HER2 mutations against which TAK-788 is active, without active CNS metastases.

  1. Have a locally advanced or metastatic solid tumor that is not NSCLC, including, but not limited to, bladder/urinary tract cancer, breast cancer, gastric/esophageal cancer, biliary tract cancer, and head and neck cancer.
  2. Is refractory to standard therapy.
  3. Have EGFR or HER2 mutations, documented by a local test.

Part 3: Extension Cohort Specific Inclusion Criteria:

  1. Have a documented EGFR in-frame exon 20 insertion by a local test and sufficient tumor tissue available for central analysis.
  2. Must have received at least 1 prior line of therapy for locally advanced or metastatic disease and no more than 2 regimens of systemic anticancer chemotherapies for locally advanced or metastatic disease.

    • Prior treatment with an EGFR TKI is allowed unless the participant had an objective response and subsequent progression as assessed by the investigator or treating physician during treatment with that prior TKI.

Exclusion Criteria:

  1. Previously received TAK-788.
  2. Received small-molecule anticancer therapy (including cytotoxic chemotherapy, and investigational agents, <=14 days prior to first dose of TAK-788 (except for reversible EGFR TKIs [that is, erlotinib or gefitinib], which are allowed in the dose escalation and expansion cohorts up to 7 days prior to the first dose of TAK-788).
  3. Received antineoplastic monoclonal antibodies including immunotherapy within 28 days of the first dose of TAK-788.
  4. Have been diagnosed with another primary malignancy other than NSCLC except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or participants with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.

    Note: This exclusion criterion does not apply to Expansion Cohort 7.

  5. Received radiotherapy <=14 days prior to the first dose of TAK-788 or has not recovered from radiotherapy-related toxicities. Palliative radiation administered outside the chest and brain, stereotactic radiosurgery (SRS), and stereotactic body radiotherapy are allowed up to 7 days prior to the first dose
  6. Received a moderate or strong CYP4503A inhibitor or moderate or strong CYP3A inducer within 10 days prior to first dose of TAK-788.
  7. Have undergone major surgery within 28 days prior to first dose of TAK-788. Minor surgical procedures, such as catheter placement or minimally invasive biopsy, are allowed.
  8. Part 1 (dose escalation) and Expansion Cohorts 1 to 3 of Part 2 (expansion phase) only:

    Have symptomatic CNS metastases at screening or asymptomatic disease requiring corticosteroids to control symptoms within 7 days prior to the first dose of TAK-788.

    Part 3 (extension cohort) and Expansion Cohorts 4 to 7 of Part 2 (expansion phase) only:

    Have known active brain metastases (have either previously untreated intracranial CNS metastases or previously treated intracranial CNS metastases with radiologically documented new or progressing CNS lesions). Brain metastases are allowed if they have been treated with surgery and/or radiation and have been stable without requiring corticosteroids to control symptoms within 7 days before the first dose of TAK-788, and have no evidence of new or enlarging brain metastases.

  9. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging) or leptomeningeal disease (symptomatic or asymptomatic).
  10. Have significant, uncontrolled, or active cardiovascular disease.
  11. Have a known history of uncontrolled hypertension. Participants with hypertension should be under treatment on study entry to control blood pressure.
  12. Have prolonged QTcF interval, or being treated with medications known to be associated with the development of Torsades de Pointes.
  13. Have an ongoing or active infection, including but not limited to, the requirement for intravenous (IV) antibiotics, or a known history of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Testing is not required in the absence of history.
  14. Currently have or have a history of interstitial lung disease, radiation pneumonitis that required steroid treatment, or drug-related pneumonitis.
  15. Female participants who are lactating and breastfeeding or have a positive urine or serum pregnancy test during the screening period.

    Note: Female participants who are lactating will be eligible if they discontinue breastfeeding.

  16. Have gastrointestinal illness or disorder that could affect oral absorption of TAK-788.
  17. Have any condition or illness that, in the opinion of the investigator, might compromise participant safety or interfere with the evaluation of the safety of the drug.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716116


Contacts
Layout table for location contacts
Contact: Takeda Study Registration Call Center +1-866-835-2233 globaloncologymedinfo@takeda.com

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Locations
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United States, Arizona
Banner MD Anderson Cancer Center Recruiting
Gilbert, Arizona, United States, 85234
The Oncology Institute of Hope and Innovation Recruiting
Tucson, Arizona, United States, 85745
United States, California
Compassionate Cancer Care Recruiting
Fountain Valley, California, United States, 92708
University of California San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Pacific Shores Medical Group Recruiting
Long Beach, California, United States, 90813-3244
City of Hope Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
University of California Irvine Health Chao Family Comprehensive Cancer Center Recruiting
Orange, California, United States, 92868-3298
Stanford Cancer Center - Palo Alto Recruiting
Palo Alto, California, United States, 94305
The Oncology Institute of Hope and Innovation Recruiting
Riverside, California, United States, 92501
The Oncology Institute of Hope and Innovation Recruiting
Whittier, California, United States, 90603
United States, Colorado
University of Colorado Cancer Center Recruiting
Denver, Colorado, United States, 80045
United States, Florida
Florida Hospital Cancer Institute Recruiting
Orlando, Florida, United States, 32804
United States, Georgia
Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Chicago Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
United States, Kansas
Cancer Center of Kansas Recruiting
Wichita, Kansas, United States, 67214
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 2114
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 2215
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 2215
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Siteman Cancer Center - Washington University Medical Campus Recruiting
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Atlantic Health - Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 7960
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28203
United States, Oregon
Oregon Health and Science University Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
United States, Tennessee
SCRI - Tennessee Oncology - Nashville - Centennial Recruiting
Nashville, Tennessee, United States, 37203
Vanderbilt - Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6307
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22908
Virginia Cancer Specialists Recruiting
Fairfax, Virginia, United States, 22031
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
China, Beijing
The 307th Hospital of Chinese Peoples Liberation Army Not yet recruiting
Beijing, Beijing, China, 100071
Beijing Chest Hospital Recruiting
Beijing, Beijing, China, 101149
Peking University Cancer Hospital/Beijing Cancer Hospital Recruiting
Haidian, Beijing, China, 100036
China, Guangdong
Affiliated Hospital of Guangdong Medical University Not yet recruiting
Zhanjiang, Guangdong, China, 524001
China, Henan
Henan Cancer Hospital Not yet recruiting
Zhengzhou, Henan, China, 450008
China, Hubei
Hubei Cancer Hospital Recruiting
Wuhan, Hubei, China, 430079
China, Jilin
Jilin Provincial Cancer Hospital (Changchun Cancer Hospital) Not yet recruiting
Changchun, Jilin, China, 130012
The First Hospital of Jilin University Not yet recruiting
Changchun, Jilin, China, 130021
China, Shanghai
Shanghai Pulmonary Hospital Recruiting
Shanghai, Shanghai, China, 200433
China, Zhejiang
The First Affiliated Hospital, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 31000
France
Hopital Pontchaillou Not yet recruiting
Rennes cedex 9, Bretagne, France, 35033
Gustave Roussy Not yet recruiting
Villejuif Cedex, Ile-de-france, France, 94805
Hopital Albert Calmette Not yet recruiting
Lille Cedex, NORD Pas-de-calais, France, 59037
Hopital de la Timone Not yet recruiting
Marseille, Provence Alpes COTE D'azur, France, 13005
Centre Leon Berard Not yet recruiting
Lyon Cedex 08, Rhone-alpes, France, 69373
Germany
Thoraxklinik Heidelberg Not yet recruiting
Heidelberg, Baden-wuerttemberg, Germany, 69126
Universitatsklinikum Frankfurt Not yet recruiting
Frankfurt am Main, Hessen, Germany, 60590
Pius Hospital Oldenburg Not yet recruiting
Oldenburg, Niedersachsen, Germany, 26121
Universitaet zu Koeln Not yet recruiting
Heidelberg, Nordrhein-westfalen, Germany, 50923
Kliniken der Stadt Koeln-Krankenhaus Koeln Merheim Not yet recruiting
Koln, Nordrhein-westfalen, Germany, 51109
HELIOS Klinikum Emil von Behring Not yet recruiting
Berlin, Germany, 14165
Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Not yet recruiting
Meldola, Forli-cesena, Italy, 47014
Istituto Clinico Humanitas Not yet recruiting
Rozzano, Milano, Italy, 20089
Centro di Riferimento Oncologico di Aviano Not yet recruiting
Aviano, Pordenone, Italy, 33081
Azienda Ospedaliero - Universitaria San Luigi Gonzaga Not yet recruiting
Orbassano, Torino, Italy, 10043
Fondazione IRCCS - Istituto Nazionale dei Tumori - Milano Not yet recruiting
Milano, Italy, 20133
Istituto Di Ricovero E Cura A Carattere Scientifico - Istituto Europeo Di Oncologia Recruiting
Milano, Italy, 20141
Azienda Ospedaliero Universitaria di Parma Not yet recruiting
Parma, Italy, 43126
Azienda USL della Romagna Not yet recruiting
Ravenna, Italy, 48121
Korea, Republic of
National Cancer Center Not yet recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 411-769
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Seoul National University Hospital Recruiting
Seoul, Gyeonggi-do, Korea, Republic of, 03080
Severance Hospital Not yet recruiting
Seoul, Gyeonggi-do, Korea, Republic of, 03722
Samsung Medical Center Recruiting
Seoul, Gyeonggi-do, Korea, Republic of, 06351
The Catholic University of Korea - Seoul St. Mary's Hospital Not yet recruiting
Seoul, Gyeonggi-do, Korea, Republic of, 06591
Asan Medical Center Recruiting
Seoul, Gyeonggi-do, Korea, Republic of, 138-876
Spain
Institut Catala d'Oncologia Recruiting
L'hospitalet de Llobregat, Barcelona, Spain, 8908
Complejo Hospitalario Universitario A Coruna Recruiting
A Coruna, LA Coruna, Spain, 15006
Hospital Universitario Puerta de Hierro - Majadahonda Not yet recruiting
Majadahonda, Madrid, Spain, 28222
Hospital General Universitario de Alicante Not yet recruiting
Alicante, Spain, 3010
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 8035
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 8036
Hospital General Universitario Gregorio Maranon Recruiting
Madrid, Spain, 28007
Hospital Clinico San Carlos Not yet recruiting
Madrid, Spain, 28040
Hospital Universitario Fundacion Jimenez Diaz Recruiting
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Spain, 41013
Hospital Universitari i Politecnic La Fe de Valencia Recruiting
Valencia, Spain, 46026
Taiwan
China Medical University Hospital Not yet recruiting
Taichung, Taichung CITY, Taiwan, 404
National Cheng Kung University Hospital Not yet recruiting
Tainan, Taipei, Taiwan, 70403
National Taiwan University Hospital - YunLin Branch Recruiting
Douliu, Yunlin, Taiwan, 640
Taichung Veterans General Hospital Not yet recruiting
Taichung, Taiwan, 40705
National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan, 100
United Kingdom
The Royal Marsden NHS Foundation Trust Not yet recruiting
London, England, United Kingdom, SW3 6JJ
The London Clinic Not yet recruiting
London, England, United Kingdom, W1G 6BW
The Christie NHS Foundation Trust Not yet recruiting
Manchester, England, United Kingdom, M20 4BX
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Takeda

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Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02716116     History of Changes
Other Study ID Numbers: AP32788-15-101
U1111-1217-7205 ( Registry Identifier: WHO )
2016-001271-68 ( EudraCT Number )
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment
Keywords provided by Takeda ( Millennium Pharmaceuticals, Inc. ):
NSCLC
EGFR
HER2
human epidermal growth factor receptor 2
exon 20 insertions
exon 19 deletions
exon 21 substitution
T790M
ErbB-2
Epidermal Growth Factor Receptor
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action