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Carcinoma, Non-Small-Cell LungPhase 1/2NCT02716116

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

A Phase 1/2 study testing TAK-788 in people with Carcinoma, Non-Small-Cell Lung, run by Takeda at 62 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
TAK-788
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
324 participants
Where
62 sitesin 10 countries
Study dates
16 Jun 2016to 29 Sep 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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
Show all 22Show fewer
  • 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.

Trial locations and contacts

62 sites in 10 countries.

62 sites in 10 countries

United States36 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • Brookwood Medical Center

    Birmingham, Alabama, 35209

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Carolinas Healthcare System

    Charlotte, North Carolina, 28204

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • The University of Chicago Medicine

    Chicago, Illinois, 60637

  • City of Hope Comprehensive Cancer Center - Duarte

    Duarte, California, 91010

  • Virginia Cancer Specialists - Fairfax Office

    Fairfax, Virginia, 22031

  • Compassionate Cancer Care - Fountain Valley

    Fountain Valley, California, 92708

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Lumi Research

    Houston, Texas, 77090

  • Investigative Clinical Research - Indiana

    Indianapolis, Indiana, 46260

  • Thompson Oncology Group - Knoxville - Downtown

    Knoxville, Tennessee, 37916

  • 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

  • Atlantic Health - Morristown Medical Center

    Morristown, New Jersey, 07960

  • SCRI - Tennessee Oncology - Nashville - Centennial

    Nashville, Tennessee, 37203

  • University of Virginia Cancer Center

    Nashville, Tennessee, 37232

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73102

  • University of California Irvine Health Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • AdventHealth Orlando

    Orlando, Florida, 32804

  • Stanford Cancer Center - Palo Alto

    Palo Alto, California, 94305

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • SLO Oncology and Hematology Health Center

    San Luis Obispo, California, 93405

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Siteman Cancer Center - Washington University Medical Campus

    St Louis, Missouri, 63110

  • The Oncology Institute of Hope and Innovation - West Tucson

    Tucson, Arizona, 85745

  • The Oncology Institute of Hope and Innovation

    Whittier, California, 90603

Other trials in United States

China5 sites

  • Peking University Cancer Hospital/Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100036

  • Beijing Chest Hospital

    Beijing, Beijing Municipality, 101149

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang, 310003

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

Other trials in China

Japan4 sites

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • Kurume University Hospital

    Kurume-shi, Fukuoka, 830-0011

  • Kindai University Hospital

    Ōsaka-sayama, Osaka, 589-8511

  • Sendai Kousei Hospital

    Sendai, Miyagi, 980-0873

Other trials in Japan

South Korea4 sites

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

Taiwan4 sites

  • National Taiwan University Hospital - YunLin Branch

    Douliu, Yunlin, 640

  • Taichung Veterans General Hospital

    Taichung, 407

  • National Cheng Kung University Hospital

    Tainan, Tainan CITY, 70403

  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

Spain3 sites

  • Complejo Hospitalario Universitario A Coruna

    A Coruña, LA Coruna, 15006

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

Other trials in Spain

Germany2 sites

  • HELIOS Klinikum Emil von Behring

    Berlin, 14165

  • Thoraxklinik Heidelberg

    Heidelberg, Baden-Wurttemberg, 69126

Other trials in Germany

Italy2 sites

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

    Milan, 20141

  • Azienda Ospedaliero Universitaria di Parma

    Parma, 43126

Other trials in Italy

Puerto Rico1 site

  • In Situ Global Clinical Trials Network

    Manati, 00674

Other trials in Puerto Rico

United Kingdom1 site

  • The Royal Marsden NHS Foundation Trust

    London, England, SW3 6JJ

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
TAK-788
Keywords
Drug Therapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAK-788Drug

    Also called AP32788

    TAK-788 capsules.

Study groups in NCT02716116
Study groupRoleWhat they receive
Part 1: Dose Escalation ComponentExperimentalTAK-788 treatment for participants with advanced NSCLC.
Receives: Drug: TAK-788
Part 2: Expansion Cohort 1ExperimentalTAK-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.
Receives: Drug: TAK-788
Part 2: Expansion Cohort 2ExperimentalTAK-788 treatment for NSCLC participants with HER2 exon 20 activating insertions or point mutations and no active, measurable CNS metastases.
Receives: Drug: TAK-788
Part 2: Expansion Cohort 3ExperimentalTAK-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.
Receives: Drug: TAK-788
Part 2: Expansion Cohort 4ExperimentalTAK-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.
Receives: Drug: TAK-788
Part 2: Expansion Cohort 5ExperimentalTAK-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.
Receives: Drug: TAK-788
Part 2: Expansion Cohort 6ExperimentalTAK-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
Receives: Drug: TAK-788
Part 2: Expansion Cohort 7ExperimentalTAK-788 treatment for participants with solid tumors other than NSCLC with EGFR/HER2 mutations against which TAK-788 is active without active CNS metastases.
Receives: Drug: TAK-788
Part 3: Extension CohortExperimentalTAK-788 treatment for participants with previously treated locally advanced or metastatic NSCLC whose tumors harbor EGFR exon 20 insertion mutations.
Receives: Drug: TAK-788

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1, Dose Escalation Component: Recommended Phase 2 Dose (RP2D) of Orally Administered TAK-788

    Measured: 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

    Measured: Up to 36 months after first dose

  3. Part 2, Expansion Cohort 3: Intracranial ORR (iORR) Assessed by Independent Review Committee (IRC)

    Measured: Up to 36 months after first dose

  4. Part 2, Expansion Cohort 6: Confirmed ORR Assessed by IRC

    Measured: Up to 36 months after first dose

  5. Part 3, Extension Cohort: Confirmed ORR Assessed by IRC

    Measured: Up to 36 months after first dose

Secondary outcomes (22)

  1. Part 1, Dose Escalation Component: Dose Limiting Toxicities (DLTs) of TAK-788

    Measured: Cycle 1 (Cycle length=28 days)

  2. Part 1, Dose Escalation Component: Maximum Tolerated Dose (MTD) of TAK-788

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Up to 36 months after first dose

  10. Part 2, Expansion Cohorts: Best Overall Response as Assessed by the Investigator and IRC

    Measured: Up to 36 months after first dose

  11. Part 2, Expansion Cohorts: Best Target Lesion Response as Assessed by the Investigator and IRC

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Up to 36 months after first dose

  16. Parts 2 and 3, Expansion and Extension Cohorts: Overall Survival (OS)

    Measured: Up to 36 months after first dose

  17. Part 2, Expansion Cohort 3: Duration of Intracranial Response (iDOR)

    Measured: up to 36 months after first dose

  18. Part 2, Expansion Cohort 3: Intracranial PFS (iPFS)

    Measured: up to 36 months after first dose

  19. Part 2, Expansion Cohorts 6: Confirmed ORR as Assessed by the Investigator

    Measured: Up to 36 months after first dose

  20. Part 3, Extension Cohort: Confirmed ORR as Assessed by the Investigator

    Measured: 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)

    Measured: 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)

    Measured: Up to 30 days after last dose of drug (approximately up to 37 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2016 (estimated)
  2. Study start16 Jun 2016
  3. Primary completion29 Sep 2026
  4. Study completion29 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
324 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02716116
Sponsor's protocol ID
AP32788-15-101
Other IDs
U1111-1217-7205, 2016-001271-68, 2016
Status last verified
Oct 2026
First submitted
14 Mar 2016
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Zhou YF, Wang GX, Yang RN, Qi H, Fan YY, Li WY, Zhao GA, Hao GL, Lin F, Chen ZG. Electrophysiological consequences of acute mobocertinib exposure in isolated rat and guinea-pig hearts and transfected cell lines. Biochem Biophys Res Commun. 2025 Sep 16;780:152460. doi: 10.1016/j.bbrc.2025.152460. Epub 2025 Aug 7.

    PubMed 40818285

  • Hanley MJ, Zhang S, Griffin R, Zhu SX, Fram RJ, Lin J, Venkatakrishnan K, Gupta N. A phase 1 study to assess the absolute bioavailability, mass balance, pharmacokinetics, metabolism, and excretion of [14C]-mobocertinib, an oral inhibitor of EGFR exon 20 insertion mutations, in healthy participants. Invest New Drugs. 2024 Aug;42(4):343-352. doi: 10.1007/s10637-024-01446-y. Epub 2024 May 24.

    PubMed 38789848

  • Ou SI, Lin HM, Hong JL, Yin Y, Jin S, Lin J, Mehta M, Zhang P, Nguyen D, Neal JW. Comparative effectiveness of mobocertinib and standard of care in patients with NSCLC with EGFR exon 20 insertion mutations: An indirect comparison. Lung Cancer. 2023 May;179:107186. doi: 10.1016/j.lungcan.2023.107186. Epub 2023 Apr 1.

    PubMed 37075617

  • Christopoulos P, Prawitz T, Hong JL, Lin HM, Hernandez L, Jin S, Tan M, Proskorovsky I, Lin J, Zhang P, Patel JD, Ou SI, Thomas M, Stenzinger A. Indirect comparison of mobocertinib and real-world therapies for pre-treated non-small cell lung cancer with EGFR exon 20 insertion mutations. Lung Cancer. 2023 May;179:107191. doi: 10.1016/j.lungcan.2023.107191. Epub 2023 Apr 8.

    PubMed 37058788

  • Ou SI, Hong JL, Christopoulos P, Lin HM, Vincent S, Churchill EN, Soeda J, Kazdal D, Stenzinger A, Thomas M. Distribution and Detectability of EGFR Exon 20 Insertion Variants in NSCLC. J Thorac Oncol. 2023 Jun;18(6):744-754. doi: 10.1016/j.jtho.2023.01.086. Epub 2023 Feb 3.

    PubMed 36738930

  • Yang JC, Zhou C, Janne PA, Ramalingam SS, Kim TM, Riely GJ, Spira AI, Piotrowska Z, Mekhail T, Garcia Campelo MR, Felip E, Bazhenova L, Jin S, Kaur M, Diderichsen PM, Gupta N, Bunn V, Lin J, N Churchill E, Mehta M, Nguyen D. Characterization and management of adverse events observed with mobocertinib (TAK-788) treatment for EGFR exon 20 insertion-positive non-small cell lung cancer. Expert Rev Anticancer Ther. 2023 Jan;23(1):95-106. doi: 10.1080/14737140.2023.2157815. Epub 2022 Dec 28.

    PubMed 36537204

  • Duke ES, Stapleford L, Drezner N, Amatya AK, Mishra-Kalyani PS, Shen YL, Maxfield K, Zirkelbach JF, Bi Y, Liu J, Zhang X, Wang H, Yang Y, Zheng N, Reece K, Wearne E, Glen JJ, Ojofeitimi I, Scepura B, Nair A, Bikkavilli RK, Ghosh S, Philip R, Pazdur R, Beaver JA, Singh H, Donoghue M. FDA Approval Summary: Mobocertinib for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations. Clin Cancer Res. 2023 Feb 1;29(3):508-512. doi: 10.1158/1078-0432.CCR-22-2072.

    PubMed 36112541

  • 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.

    PubMed 34647988

  • 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.

    PubMed 34380634

  • 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.

    PubMed 33632775

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TAK-788 in people with Carcinoma, Non-Small-Cell Lung, run by Takeda at 62 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, China, Japan, South Korea, Taiwan and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02716116, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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