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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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.

Key facts

Study ID

NCT02716116

Run by

Takeda

People needed

334

Starts

2016-06-16

Expected to finish

2026-10-31

Last updated by the study team

2026-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Previously received TAK-788.
• 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).
• Received antineoplastic monoclonal antibodies including immunotherapy within 28 days of the first dose of TAK-788.
• 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.
• 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 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 prolonged QTcF interval, or being treated with medications known to be associated with the development of torsades de pointes.
• 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.
• 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.
• 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.

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• The Oncology Institute of Hope and Innovation - West Tucson — Tucson, Arizona, United States
• City of Hope Comprehensive Cancer Center - Duarte — Duarte, California, United States
• Compassionate Cancer Care - Fountain Valley — Fountain Valley, California, United States
• University of California San Diego Moores Cancer Center — La Jolla, California, United States
• Pacific Shores Medical Group-Long Beach Elm — Long Beach, California, United States
• Cancer and Blood Specialty Clinic — Los Alamitos, California, United States
• University of California Irvine Health Chao Family Comprehensive Cancer Center — Orange, California, United States
• Stanford Cancer Center - Palo Alto — Palo Alto, California, United States
• SLO Oncology and Hematology Health Center — San Luis Obispo, California, United States
• The Oncology Institute of Hope and Innovation — Whittier, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• AdventHealth Orlando — Orlando, Florida, United States
• Winship Cancer Institute — Atlanta, Georgia, United States
• The University of Chicago Medicine — Chicago, Illinois, United States
• Investigative Clinical Research - Indiana — Indianapolis, Indiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Siteman Cancer Center - Washington University Medical Campus — St Louis, Missouri, United States
• Atlantic Health - Morristown Medical Center — Morristown, New Jersey, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• Brookwood Medical Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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