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Active, not recruiting Phase 1Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT02716116

Public ClinicalTrials.gov record NCT02716116. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 25, 2026, 12:14 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02716116
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Takeda
Industry
Enrollment
334 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 15, 2016
Primary completion
Oct 30, 2026
Completion
Oct 30, 2026
Last update posted
Feb 24, 2026

2016 – 2026

United States locations

U.S. sites
36
U.S. states
20
U.S. cities
31
Facility City State ZIP Site status
Brookwood Medical Center Birmingham Alabama 35209 —
Banner MD Anderson Cancer Center Gilbert Arizona 85234 —
The Oncology Institute of Hope and Innovation - West Tucson Tucson Arizona 85745 —
City of Hope Comprehensive Cancer Center - Duarte Duarte California 91010 —
Compassionate Cancer Care - Fountain Valley Fountain Valley California 92708 —
University of California San Diego Moores Cancer Center La Jolla California 92093 —
Pacific Shores Medical Group-Long Beach Elm Long Beach California 90813 —
Cancer and Blood Specialty Clinic Los Alamitos California 90720 —
University of California Irvine Health Chao Family Comprehensive Cancer Center Orange California 92868 —
Stanford Cancer Center - Palo Alto Palo Alto California 94305 —
SLO Oncology and Hematology Health Center San Luis Obispo California 93405 —
The Oncology Institute of Hope and Innovation Whittier California 90603 —
University of Colorado Cancer Center Aurora Colorado 80045 —
AdventHealth Orlando Orlando Florida 32804 —
Winship Cancer Institute Atlanta Georgia 30322 —
The University of Chicago Medicine Chicago Illinois 60637 —
Investigative Clinical Research - Indiana Indianapolis Indiana 46260 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 —
Dana Farber Cancer Institute Boston Massachusetts 02215 —
University of Michigan Comprehensive Cancer Center Ann Arbor Michigan 48109 —
Siteman Cancer Center - Washington University Medical Campus St Louis Missouri 63110 —
Atlantic Health - Morristown Medical Center Morristown New Jersey 07960 —
Memorial Sloan Kettering Cancer Center New York New York 10065 —
Levine Cancer Institute Charlotte North Carolina 28203 —
Carolinas Healthcare System Charlotte North Carolina 28204 —
Hightower Clinical Oklahoma City Oklahoma 73102 —
Oregon Health and Science University Portland Oregon 97239 —
Thompson Oncology Group - Knoxville - Downtown Knoxville Tennessee 37916 —
SCRI - Tennessee Oncology - Nashville - Centennial Nashville Tennessee 37203 —
University of Virginia Cancer Center Nashville Tennessee 37232 —
The University of Texas MD Anderson Cancer Center Houston Texas 77030 —
Lumi Research Houston Texas 77090 —
University of Virginia Cancer Center Charlottesville Virginia 22908 —
Virginia Cancer Specialists - Fairfax Office Fairfax Virginia 22031 —
Swedish Cancer Institute Seattle Washington 98104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 26 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02716116, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 24, 2026 · Synced Sep 25, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02716116 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →