A Study of TAK-788 in Adults With Non-Small Cell Lung Cancer

• ClinicalTrials.gov Identifier: NCT02716116
• Recruitment Status: Active, not recruiting
• First Posted: March 23, 2016
• Last Update Posted: October 18, 2023
• Sponsor: Takeda
• Information provided by (Responsible Party): Takeda

Study Description

Brief Summary:

This study is about a medicine called TAK-788, also known as mobocertinib, given to adults with non-small cell lung cancer. The main aims of this study are to check if there are any side effects from TAK-788, to learn how TAK-788 is processed by the body, and to determine the best dose of TAK-788 to treat this condition. Participants will take TAK-788 capsules with chemotherapy. Participants will continue to take TAK-788 unless they or their doctor decide they should stop this treatment. Participants will take TAK-788 capsules with or without chemotherapy under antidiarrhea prevention to determine the safety of TAK-788 treatment. Non-Asian, non-White participants will take TAK-788 to determine the safety and tolerability of TAK-788 treatment.

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 (Part 1), expansion phase (Part 2), followed by an extension phase (Part 3).

The objectives of the dose escalation phase (Part 1), is to determine the safety profile of orally administered TAK-788, including the MTD, DLTs, RP2D, 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 enrolled 324 participants.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 334 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: June 16, 2016
• Estimated Primary Completion Date: March 28, 2025
• Estimated Study Completion Date: March 28, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Part 1: Dose Escalation Component; TAK-788 treatment for participants with advanced NSCLC.	Drug: TAK-788; TAK-788 capsules.; Other Name: AP32788
Experimental: Part 2: 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: Part 2: 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: Part 2: 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: Part 2: 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: Part 2: 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: Part 2: 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: Part 2: 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: Part 3: 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

Outcome Measures

Primary Outcome Measures :

1. Part 1, Dose Escalation Component: Recommended Phase 2 Dose (RP2D) of Orally Administered TAK-788 [ Time Frame: Cycle 1 (Cycle length is equal to [=] 28 days) ]
2. Part 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. Part 2, Expansion Cohort 3: Intracranial ORR (iORR) Assessed by Independent Review Committee (IRC) [ Time Frame: Up to 36 months after first dose ]
4. Part 2, Expansion Cohort 6: Confirmed ORR Assessed by IRC [ Time Frame: Up to 36 months after first dose ]
5. Part 3, Extension Cohort: Confirmed ORR Assessed by IRC [ Time Frame: Up to 36 months after first dose ]

Secondary Outcome Measures :

1. Part 1, Dose Escalation Component: Dose Limiting Toxicities (DLTs) of TAK-788 [ Time Frame: Cycle 1 (Cycle length=28 days) ]
2. Part 1, Dose Escalation Component: Maximum Tolerated Dose (MTD) of TAK-788 [ Time Frame: Cycle 1 (Cycle length=28 days) ]
3. Parts 1 and 2, Dose Escalation and Expansion Cohorts: Cmax; Maximum Observed Concentration of TAK-788 and its Metabolites [ Time Frame: Cycle 1 Day 1 and Cycle 2 Day 1 (cycle length=28 days for Parts 1 and 2) ]
4. Parts 1 and 2, Dose Escalation and Expansion Cohorts: Tmax; Time of First Occurrence of Maximum Plasma Concentration (Cmax) of TAK-788 and its Metabolites [ Time Frame: Cycle 1 Day 1 and Cycle 2 Day 1 (cycle length=28 days for Parts 1 and 2) ]
5. Parts 1 and 2, Dose Escalation and Expansion Cohorts: AUC 24; Area Under the Concentration-time Curve from Time Zero to 24 hours for TAK-788 and its Metabolites [ Time Frame: Cycle 1 Day 1 and Cycle 2 Day 1 (cycle length=28 days for Parts 1 and 2) ]
6. Parts 1 and 2, Dose Escalation and Expansion Cohorts: AUCt: Area Under the Concentration-time Curve from Time Zero to Time t for TAK-788 and its Metabolites [ Time Frame: Cycle 1 Day 1 and Cycle 2 Day 1 (cycle length=28 days for Parts 1 and 2) ]
7. Parts 1 and 2, Dose Escalation and Expansion Cohorts: RAC (Cmax): Accumulation Ratio Based on Cmax of TAK-788 and its Metabolites [ Time Frame: Cycle 1 Day 1 and Cycle 2 Day 1 (cycle length=28 days for Parts 1 and 2) ]
8. Parts 1 and 2, Dose Escalation and Expansion Cohorts: RAC (AUC): Accumulation Ratio Based on AUC of TAK-788 and its Metabolites [ Time Frame: Cycle 1 Day 1 and Cycle 2 Day 1 (cycle length=28 days for Parts 1 and 2) ]
9. Part 2, Expansion Cohorts 1, 2, 3, 4, 5, and 7: Confirmed ORR as Assessed by IRC [ Time Frame: Up to 36 months after first dose ]
10. Part 2, Expansion Cohorts: Best Overall Response as Assessed by the Investigator and IRC [ Time Frame: Up to 36 months after first dose ]
11. Part 2, Expansion Cohorts: Best Target Lesion Response as Assessed by the Investigator and IRC [ Time Frame: Up to 36 months after first dose ]
12. Parts 2 and 3, Expansion and Extension Cohorts: Duration of Response as Assessed by the Investigator and IRC [ Time Frame: Up to 36 months after first dose ]
13. Parts 2 and 3, Expansion and Extension Cohorts: Disease Control Rate (DCR) as Assessed by the Investigator and IRC [ Time Frame: Up to 36 months after first dose ]
14. Part 2 and 3, Expansion and Extension Cohorts: Time to Response as Assessed by the Investigator and IRC [ Time Frame: Up to 36 months after first dose ]
15. Parts 2 and 3, Expansion and Extension Cohorts: Progression Free Survival (PFS) as Assessed by the Investigator and IRC [ Time Frame: Up to 36 months after first dose ]
16. Parts 2 and 3, Expansion and Extension Cohorts: Overall Survival (OS) [ Time Frame: Up to 36 months after first dose ]
17. Part 2, Expansion Cohort 3: Duration of Intracranial Response (iDOR) [ Time Frame: up to 36 months after first dose ]
18. Part 2, Expansion Cohort 3: Intracranial PFS (iPFS) [ Time Frame: up to 36 months after first dose ]
19. Part 2, Expansion Cohorts 6: Confirmed ORR as Assessed by the Investigator [ Time Frame: Up to 36 months after first dose ]
20. Part 3, Extension Cohort: Confirmed ORR as Assessed by the Investigator [ Time Frame: Up to 36 months after first dose ]
21. Part 3, 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) ]
22. Part 3, Extension Cohort: 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) ]

Eligibility Criteria

• 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, antidiarrhea prophylaxis, dose escalation combination, expansion, and extension:

1. Have histologically or cytologically confirmed locally advanced (and not a candidate for definitive therapy) or metastatic NSCLC disease (Stage IIIB or IV) or other solid tumors. 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.
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.

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. With an EGFR exon 20 insertion: 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.

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.
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 (greater than or equal to [ ≥ ]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, and 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 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 criteria 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, 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.

Contacts and Locations

Locations

United States, Alabama

Brookwood Medical Center

Birmingham, Alabama, United States, 35209

United States, Arizona

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234

The Oncology Institute of Hope and Innovation - West Tucson

Tucson, Arizona, United States, 85745

United States, California

City of Hope Comprehensive Cancer Center - Duarte

Duarte, California, United States, 91010

Compassionate Cancer Care - Fountain Valley

Fountain Valley, California, United States, 92708

University of California San Diego Moores Cancer Center

La Jolla, California, United States, 92093

Pacific Shores Medical Group-Long Beach Elm

Long Beach, California, United States, 90813

Cancer and Blood Specialty Clinic

Los Alamitos, California, United States, 90720

University of California Irvine Health Chao Family Comprehensive Cancer Center

Orange, California, United States, 92868

Stanford Cancer Center - Palo Alto

Palo Alto, California, United States, 94305

SLO Oncology and Hematology Health Center

San Luis Obispo, California, United States, 93405

The Oncology Institute of Hope and Innovation

Whittier, California, United States, 90603

United States, Colorado

University of Colorado Cancer Center

Aurora, Colorado, United States, 80045

United States, Florida

AdventHealth Orlando

Orlando, Florida, United States, 32804

United States, Georgia

Winship Cancer Institute

Atlanta, Georgia, United States, 30322

United States, Illinois

The University of Chicago Medicine

Chicago, Illinois, United States, 60637

United States, Indiana

Investigative Clinical Research - Indiana

Indianapolis, Indiana, United States, 46260

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

United States, Michigan

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States, 48109

United States, Missouri

Siteman Cancer Center - Washington University Medical Campus

Saint Louis, Missouri, United States, 63110

United States, New Jersey

Atlantic Health - Morristown Medical Center

Morristown, New Jersey, United States, 07960

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

United States, North Carolina

Levine Cancer Institute

Charlotte, North Carolina, United States, 28203

Carolinas Healthcare System

Charlotte, North Carolina, United States, 28204

United States, Oklahoma

Hightower Clinical

Oklahoma City, Oklahoma, United States, 73102

United States, Oregon

Oregon Health and Science University

Portland, Oregon, United States, 97239

United States, Tennessee

Thompson Oncology Group - Knoxville - Downtown

Knoxville, Tennessee, United States, 37916

SCRI - Tennessee Oncology - Nashville - Centennial

Nashville, Tennessee, United States, 37203

University of Virginia Cancer Center

Nashville, Tennessee, United States, 37232

United States, Texas

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Lumi Research

Houston, Texas, United States, 77090

United States, Virginia

University of Virginia Cancer Center

Charlottesville, Virginia, United States, 22908

Virginia Cancer Specialists - Fairfax Office

Fairfax, Virginia, United States, 22031

United States, Washington

Swedish Cancer Institute

Seattle, Washington, United States, 98104

China, Beijing

Peking University Cancer Hospital/Beijing Cancer Hospital

Beijing, Beijing, China, 100036

Beijing Chest Hospital

Beijing, Beijing, China, 101149

China, Hubei

Hubei Cancer Hospital

Wuhan, Hubei, China, 430079

China, Shanghai

Shanghai Pulmonary Hospital

Shanghai, Shanghai, China, 200433

China, Zhejiang

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, China, 310003

Germany

Thoraxklinik Heidelberg

Heidelberg, Baden-wuerttemberg, Germany, 69126

HELIOS Klinikum Emil von Behring

Berlin, Germany, 14165

Italy

Istituto Di Ricovero E Cura A Carattere Scientifico - Istituto Europeo Di Oncologia

Milano, Italy, 20141

Azienda Ospedaliero Universitaria di Parma

Parma, Italy, 43126

Japan

National Cancer Center Hospital East

Kashiwa, Chiba, Japan, 277-8577

Kurume University Hospital

Kurume-shi, Fukuoka, Japan, 830-0011

Sendai Kousei Hospital

Sendai, Miyagi, Japan, 980-0873

Kindai University Hospital

Osaka-sayama, Osaka, Japan, 589-8511

Korea, Republic of

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Severance Hospital

Seoul, Korea, Republic of, 03722

Asan Medical Center

Seoul, Korea, Republic of, 05505

Puerto Rico

In Situ Global Clinical Trials Network

Manati, Puerto Rico, 00674

Spain

Complejo Hospitalario Universitario A Coruna

A Coruna, LA Coruna, Spain, 15006

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 08035

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

Taiwan

National Cheng Kung University Hospital

Tainan, Tainan CITY, Taiwan, 70403

National Taiwan University Hospital - YunLin Branch

Douliu, Yunlin, Taiwan, 640

Taichung Veterans General Hospital

Taichung, Taiwan, 407

National Taiwan University Hospital

Taipei, Taiwan, 100

United Kingdom

The Royal Marsden NHS Foundation Trust

London, England, United Kingdom, SW3 6JJ

Sponsors and Collaborators

Takeda

Investigators

• Study Director: Study Director; Takeda

More Information

Additional Information:

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Zhou C, Ramalingam SS, Kim TM, Kim SW, Yang JC, Riely GJ, Mekhail T, Nguyen D, Garcia Campelo MR, Felip E, Vincent S, Jin S, Griffin C, Bunn V, Lin J, Lin HM, Mehta M, Janne PA. Treatment Outcomes and Safety of Mobocertinib in Platinum-Pretreated Patients With EGFR Exon 20 Insertion-Positive Metastatic Non-Small Cell Lung Cancer: A Phase 1/2 Open-label Nonrandomized Clinical Trial. JAMA Oncol. 2021 Dec 1;7(12):e214761. doi: 10.1001/jamaoncol.2021.4761. Epub 2021 Dec 16. Erratum In: JAMA Oncol. 2022 Feb 24;: JAMA Oncol. 2022 Sep 1;8(9):1359.

Han H, Li S, Chen T, Fitzgerald M, Liu S, Peng C, Tang KH, Cao S, Chouitar J, Wu J, Peng D, Deng J, Gao Z, Baker TE, Li F, Zhang H, Pan Y, Ding H, Hu H, Pyon V, Thakurdin C, Papadopoulos E, Tang S, Gonzalvez F, Chen H, Rivera VM, Brake R, Vincent S, Wong KK. Targeting HER2 Exon 20 Insertion-Mutant Lung Adenocarcinoma with a Novel Tyrosine Kinase Inhibitor Mobocertinib. Cancer Res. 2021 Oct 15;81(20):5311-5324. doi: 10.1158/0008-5472.CAN-21-1526. Epub 2021 Aug 11.

Riely GJ, Neal JW, Camidge DR, Spira AI, Piotrowska Z, Costa DB, Tsao AS, Patel JD, Gadgeel SM, Bazhenova L, Zhu VW, West HL, Mekhail T, Gentzler RD, Nguyen D, Vincent S, Zhang S, Lin J, Bunn V, Jin S, Li S, Janne PA. Activity and Safety of Mobocertinib (TAK-788) in Previously Treated Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations from a Phase I/II Trial. Cancer Discov. 2021 Jul;11(7):1688-1699. doi: 10.1158/2159-8290.CD-20-1598. Epub 2021 Feb 25. Erratum In: Cancer Discov. 2023 Sep 6;13(9):2107.

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT02716116
• Other Study ID Numbers: AP32788-15-101; U1111-1217-7205 ( Registry Identifier: WHO ); 2016-001271-68 ( EudraCT Number )
• First Posted: March 23, 2016
• Last Update Posted: October 18, 2023
• Last Verified: October 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• URL: https://vivli.org/ourmember/takeda/

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda:

Drug Therapy

Additional relevant MeSH terms:

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; Mobocertinib; Tyrosine Kinase Inhibitors; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action