NCT02716116CompletedPhase 1/2

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

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

Source: ClinicalTrials.gov · Last updated 28 Oct 2026

Brief summary (registry, in English)

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.

Status (registry): Completed
Phase (registry): Phase 1/2
Study type: Interventional
Enrollment: 324 (actual)
First submitted: 14 Mar 2016
Start date: 16 Jun 2016
Primary completion date: 29 Sept 2026
Lead sponsor: Takeda
Diseases: Lung cancer
NCT number: NCT02716116
EudraCT number: 2016-001271-68

What you commit to

Study type: Interventional · Phase 1/2
Participants enrolled: 324
From 16 Jun 2016 to the primary completion date, 29 Sept 2026
62 sites in 10 countries
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Previously received TAK-788.
Received antineoplastic monoclonal antibodies including immunotherapy within 28 days of the first dose of TAK-788.
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
Received a moderate or strong CYP4503A inhibitor or moderate or strong CYP3A inducer within 10 days prior to first dose of TAK-788.
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.
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.
Have prolonged QTcF interval, or being treated with medications known to be associated with the development of torsades de pointes.

Other illness

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.
Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging) or leptomeningeal disease (symptomatic or asymptomatic).
Have significant, uncontrolled, or active cardiovascular disease.
Have a known history of uncontrolled hypertension. Participants with hypertension should be under treatment on study entry to control blood pressure.
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.
Currently have or have a history of interstitial lung disease, radiation pneumonitis that required steroid treatment, or drug-related pneumonitis.
Have gastrointestinal illness or disorder that could affect oral absorption of TAK-788.
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.

Lab values

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).
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.

Criteria the registry did not label

General Inclusion Criteria all cohorts: dose escalation, antidiarrhea prophylaxis, dose escalation combination, expansion, and extension:
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.
Must have sufficient tumor tissue available for analysis.
Must have measurable disease by response evaluation criteria in solid tumors (RECIST) v1.1.
Male or female adult participants (aged 18 years or older, or as defined per local regulations).
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
Minimum life expectancy of 3 months or more.
Adequate organ function at baseline.
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.
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:
Have a documented EGFR in-frame exon 20 insertion by a local test.
Previously treated with one or more regimens of systemic therapy for locally advanced or metastatic disease.
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:
Have one of the following documented by a local test:
- A HER2 exon 20 insertion;
- An activating point mutation in HER2.
Previously treated with one or more regimens of systemic therapy for locally advanced or metastatic disease.
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:
Have one of the following documented by a local test:
- An EGFR exon 20 insertion;
- A HER2 exon 20 insertion;
- An activating point mutation in HER2.
Previously treated with one or more regimen of systemic therapy for locally advanced or metastatic disease.
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.
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.
Have either previously untreated intracranial CNS metastases or previously treated intracranial CNS metastases with radiologically documented new or progressing CNS lesions.
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:
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.
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.
Have a documented EGFR in-frame exon 20 insertion by a local test.
Previously treated with one or more regimens of systemic therapy for locally advanced or metastatic disease.
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.
Have a documented EGFR in-frame exon 20 insertion by a local test.
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.
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.
Is refractory to standard therapy.
Have EGFR or HER2 mutations, documented by a local test.
- Part 3: Extension Cohort Specific Inclusion Criteria:
Have a documented EGFR in-frame exon 20 insertion by a local test and sufficient tumor tissue available for central analysis.
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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (62)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Beijing Chest Hospital Coordinator of this site? Confirm its status	Beijing	China	Unknown status
Peking University Cancer Hospital/Beijing Cancer Hospital Coordinator of this site? Confirm its status	Beijing	China	Unknown status
The First Affiliated Hospital, Zhejiang University Coordinator of this site? Confirm its status	Hangzhou	China	Unknown status
Shanghai Pulmonary Hospital Coordinator of this site? Confirm its status	Shanghai	China	Unknown status
Hubei Cancer Hospital Coordinator of this site? Confirm its status	Wuhan	China	Unknown status
Helios Klinikum Emil von Behring Coordinator of this site? Confirm its status	Berlin	Germany	Unknown status
Thoraxklinik Heidelberg Coordinator of this site? Confirm its status	Heidelberg	Germany	Unknown status
Complejo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status	A Coruña	Spain	Unknown status
Hospital Clinic de Barcelona Coordinator of this site? Confirm its status	Barcelona	Spain	Unknown status
Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status	Barcelona	Spain	Unknown status
The Royal Marsden NHS Foundation Trust Coordinator of this site? Confirm its status	London	United Kingdom	Unknown status
Istituto Di Ricovero E Cura A Carattere Scientifico - Istituto Europeo Di Oncologia Coordinator of this site? Confirm its status	Milan	Italy	Unknown status
Azienda Ospedaliero Universitaria di Parma Coordinator of this site? Confirm its status	Parma	Italy	Unknown status
National Cancer Center Hospital East Coordinator of this site? Confirm its status	Kashiwa	Japan	Unknown status
Kurume University Hospital Coordinator of this site? Confirm its status	Kurume-shi	Japan	Unknown status
Kindai University Hospital Coordinator of this site? Confirm its status	Ōsaka-sayama	Japan	Unknown status
Sendai Kousei Hospital Coordinator of this site? Confirm its status	Sendai	Japan	Unknown status
Seoul National University Bundang Hospital Coordinator of this site? Confirm its status	Seongnam-si	South Korea	Unknown status
Severance hospital Coordinator of this site? Confirm its status	Seoul	South Korea	Unknown status
Seoul National University Hospital Coordinator of this site? Confirm its status	Seoul	South Korea	Unknown status
Asan Medical Center Coordinator of this site? Confirm its status	Seoul	South Korea	Unknown status
In Situ Global Clinical Trials Network Coordinator of this site? Confirm its status	Manati	Puerto Rico	Unknown status
National Taiwan University Hospital Yunlin Branch Coordinator of this site? Confirm its status	Douliu	Taiwan	Unknown status
Taichung Veterans General Hospital Coordinator of this site? Confirm its status	Taichung	Taiwan	Unknown status
National Cheng Kung University Hospital Coordinator of this site? Confirm its status	Tainan	Taiwan	Unknown status
National Taiwan University Hospital Coordinator of this site? Confirm its status	Taipei	Taiwan	Unknown status
University Of Michigan Comprehensive Cancer Center Coordinator of this site? Confirm its status	Ann Arbor	United States	Unknown status
Winship Cancer Institute Coordinator of this site? Confirm its status	Atlanta	United States	Unknown status
University of Colorado Cancer Center Coordinator of this site? Confirm its status	Aurora	United States	Unknown status
Brookwood Medical Center Coordinator of this site? Confirm its status	Birmingham	United States	Unknown status
Massachusetts General Hospital Coordinator of this site? Confirm its status	Boston	United States	Unknown status
Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status	Boston	United States	Unknown status
Dana-Farber Cancer Institute Coordinator of this site? Confirm its status	Boston	United States	Unknown status
Carolinas Healthcare System Coordinator of this site? Confirm its status	Charlotte	United States	Unknown status
Levine Cancer Institute Coordinator of this site? Confirm its status	Charlotte	United States	Unknown status
University of Virginia Cancer Center Coordinator of this site? Confirm its status	Charlottesville	United States	Unknown status
The University of Chicago Medicine Coordinator of this site? Confirm its status	Chicago	United States	Unknown status
City of Hope Comprehensive Cancer Center - Duarte Coordinator of this site? Confirm its status	Duarte	United States	Unknown status
Virginia Cancer Specialists - Fairfax Office Coordinator of this site? Confirm its status	Fairfax	United States	Unknown status
Compassionate Cancer Care - Fountain Valley Coordinator of this site? Confirm its status	Fountain Valley	United States	Unknown status
Banner MD Anderson Cancer Center Coordinator of this site? Confirm its status	Gilbert	United States	Unknown status
Lumi Research Coordinator of this site? Confirm its status	Houston	United States	Unknown status
The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status	Houston	United States	Unknown status
Investigative Clinical Research - Indiana Coordinator of this site? Confirm its status	Indianapolis	United States	Unknown status
Thompson Oncology Group - Knoxville - Downtown Coordinator of this site? Confirm its status	Knoxville	United States	Unknown status
University of California San Diego Moores Cancer Center Coordinator of this site? Confirm its status	La Jolla	United States	Unknown status
Pacific Shores Medical Group-Long Beach Elm Coordinator of this site? Confirm its status	Long Beach	United States	Unknown status
Cancer and Blood Specialty Clinic Coordinator of this site? Confirm its status	Los Alamitos	United States	Unknown status
Atlantic Health - Morristown Medical Center Coordinator of this site? Confirm its status	Morristown	United States	Unknown status
SCRI - Tennessee Oncology - Nashville - Centennial Coordinator of this site? Confirm its status	Nashville	United States	Unknown status
University of Virginia Cancer Center Coordinator of this site? Confirm its status	Nashville	United States	Unknown status
Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status	New York	United States	Unknown status
Hightower Clinical Coordinator of this site? Confirm its status	Oklahoma City	United States	Unknown status
University of California Irvine Health Chao Family Comprehensive Cancer Center Coordinator of this site? Confirm its status	Orange	United States	Unknown status
AdventHealth Orlando Coordinator of this site? Confirm its status	Orlando	United States	Unknown status
Stanford Cancer Center - Palo Alto Coordinator of this site? Confirm its status	Palo Alto	United States	Unknown status
Oregon Health and Science University Coordinator of this site? Confirm its status	Portland	United States	Unknown status
SLO Oncology and Hematology Health Center Coordinator of this site? Confirm its status	San Luis Obispo	United States	Unknown status
Swedish Cancer Institute Coordinator of this site? Confirm its status	Seattle	United States	Unknown status
Siteman Cancer Center - Washington University Medical Campus Coordinator of this site? Confirm its status	St Louis	United States	Unknown status
The Oncology Institute of Hope and Innovation - West Tucson Coordinator of this site? Confirm its status	Tucson	United States	Unknown status
The Oncology Institute of Hope and Innovation Coordinator of this site? Confirm its status	Whittier	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.