New pill shows promise against lung cancer in early trial

NCT ID NCT02716116

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an oral drug called TAK-788 (mobocertinib) in adults with advanced non-small cell lung cancer. The goal is to find the best dose, check safety, and see if the drug shrinks tumors. Participants take TAK-788 capsules, sometimes with chemotherapy, and continue treatment as long as it helps and side effects are manageable.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 334 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2016

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, non-small-cell lung

Contacts and locations

Locations

AdventHealth Orlando

Orlando, Florida, 32804, United States
Asan Medical Center

Seoul, 05505, South Korea
Atlantic Health - Morristown Medical Center

Morristown, New Jersey, 07960, United States
Azienda Ospedaliero Universitaria di Parma

Parma, 43126, Italy
Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States
Beijing Chest Hospital

Beijing, Beijing Municipality, 101149, China
Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States
Brookwood Medical Center

Birmingham, Alabama, 35209, United States
Cancer and Blood Specialty Clinic

Los Alamitos, California, 90720, United States
Carolinas Healthcare System

Charlotte, North Carolina, 28204, United States
City of Hope Comprehensive Cancer Center - Duarte

Duarte, California, 91010, United States
Compassionate Cancer Care - Fountain Valley

Fountain Valley, California, 92708, United States
Complejo Hospitalario Universitario A Coruna

A Coruña, LA Coruna, 15006, Spain
Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States
HELIOS Klinikum Emil von Behring

Berlin, 14165, Germany
Hightower Clinical

Oklahoma City, Oklahoma, 73102, United States
Hospital Clinic de Barcelona

Barcelona, 08036, Spain
Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain
Hubei Cancer Hospital

Wuhan, Hubei, 430079, China
In Situ Global Clinical Trials Network

Manati, 00674, Puerto Rico
Investigative Clinical Research - Indiana

Indianapolis, Indiana, 46260, United States
Istituto Di Ricovero E Cura A Carattere Scientifico - Istituto Europeo Di Oncologia

Milan, 20141, Italy
Kindai University Hospital

Ōsaka-sayama, Osaka, 589-8511, Japan
Kurume University Hospital

Kurume-shi, Fukuoka, 830-0011, Japan
Levine Cancer Institute

Charlotte, North Carolina, 28203, United States
Lumi Research

Houston, Texas, 77090, United States
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan
National Cheng Kung University Hospital

Tainan, Tainan CITY, 70403, Taiwan
National Taiwan University Hospital

Taipei, 100, Taiwan
National Taiwan University Hospital - YunLin Branch

Douliu, Yunlin, 640, Taiwan
Oregon Health and Science University

Portland, Oregon, 97239, United States
Pacific Shores Medical Group-Long Beach Elm

Long Beach, California, 90813, United States
Peking University Cancer Hospital/Beijing Cancer Hospital

Beijing, Beijing Municipality, 100036, China
SCRI - Tennessee Oncology - Nashville - Centennial

Nashville, Tennessee, 37203, United States
SLO Oncology and Hematology Health Center

San Luis Obispo, California, 93405, United States
Sendai Kousei Hospital

Sendai, Miyagi, 980-0873, Japan
Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea
Seoul National University Hospital

Seoul, 03080, South Korea
Severance Hospital

Seoul, 03722, South Korea
Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China
Siteman Cancer Center - Washington University Medical Campus

St Louis, Missouri, 63110, United States
Stanford Cancer Center - Palo Alto

Palo Alto, California, 94305, United States
Swedish Cancer Institute

Seattle, Washington, 98104, United States
Taichung Veterans General Hospital

Taichung, 407, Taiwan
The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, 310003, China
The Oncology Institute of Hope and Innovation

Whittier, California, 90603, United States
The Oncology Institute of Hope and Innovation - West Tucson

Tucson, Arizona, 85745, United States
The Royal Marsden NHS Foundation Trust

London, England, SW3 6JJ, United Kingdom
The University of Chicago Medicine

Chicago, Illinois, 60637, United States
The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States
Thompson Oncology Group - Knoxville - Downtown

Knoxville, Tennessee, 37916, United States
Thoraxklinik Heidelberg

Heidelberg, Baden-Wurttemberg, 69126, Germany
University of California Irvine Health Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States
University of California San Diego Moores Cancer Center

La Jolla, California, 92093, United States
University of Colorado Cancer Center

Aurora, Colorado, 80045, United States
University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States
University of Virginia Cancer Center

Nashville, Tennessee, 37232, United States
University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States
Virginia Cancer Specialists - Fairfax Office

Fairfax, Virginia, 22031, United States
Winship Cancer Institute

Atlanta, Georgia, 30322, United States

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