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Tyrosine Kinase Inhibitor

TAK-788 for Non-Small Cell Lung Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Millennium Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

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 (Extension Cohort Specific Inclusion Criteria)

Previously untreated intracranial CNS metastases or previously treated intracranial CNS metastases with radiologically documented new or progressing CNS lesions (Expansion Cohort 3 Specific Inclusion Criteria)

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial is testing a new cancer drug, TAK-788, to see if it's safe and effective in treating non-small cell lung cancer.

Who is the study for?

Adults with advanced non-small cell lung cancer (NSCLC) who have specific genetic mutations in their tumors and haven't responded to standard treatments can join. They must have a normal heart rhythm, adequate organ function, and at least a 3-month life expectancy. Those with certain other cancers or active brain metastases cannot participate.Check my eligibility

What is being tested?

The trial is testing TAK-788 (mobocertinib), which participants will take as capsules possibly combined with chemotherapy. The study aims to find the best dose by assessing side effects, how the body processes it, and its safety across different patient groups.See study design

What are the potential side effects?

Potential side effects of TAK-788 include digestive issues that may require antidiarrhea prevention measures. Other risks are not specified but typically could involve fatigue, skin reactions, changes in blood tests or liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've had 1 or 2 treatments for my advanced cancer.

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I have new or worsening brain metastases that haven't been treated before.

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My cancer has a specific EGFR mutation, but not the exon 20 insertion.

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My NSCLC with EGFR exon 20 mutation responded to treatment but has worsened without spreading to my brain.

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My lung cancer has a specific genetic change and hasn't been treated yet for its advanced stage.

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My cancer, not lung, has specific mutations and no brain metastases.

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My cancer is advanced or has spread and is confirmed by lab tests.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days after last dose of drug (approximately up to 37 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days after last dose of drug (approximately up to 37 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after last dose of drug (approximately up to 37 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

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

+2 more

Secondary outcome measures

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

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

Part 2 and 3, Expansion and Extension Cohorts: Time to Response as Assessed by the Investigator and IRC

+19 more

Side effects data

From 2021 Phase 1 trial • 26 Patients • NCT04051827

96%

Diarrhoea

65%

Nausea

50%

Decreased appetite

50%

Fatigue

35%

Rash

35%

Vomiting

27%

Blood creatinine increased

27%

Dyspepsia

23%

Dry skin

19%

Anaemia

19%

Cough

19%

Weight decreased

15%

Dermatitis acneiform

15%

Alopecia

15%

Epistaxis

15%

Pruritus

15%

Hypomagnesaemia

15%

Dizziness

15%

Gastrooesophageal reflux disease

15%

Mucosal inflammation

15%

Stomatitis

15%

Urinary tract infection

12%

Dyspnoea

12%

Constipation

12%

Amylase increased

12%

Dehydration

12%

Musculoskeletal chest pain

12%

Headache

12%

Hyperkalaemia

12%

Paronychia

12%

Lipase increased

Pyrexia

Chills

Dry mouth

Abdominal pain

Acute kidney injury

Angular cheilitis

Arthralgia

Dysgeusia

Hypercalcaemia

Hypertension

Hypokalaemia

Hypophosphataemia

Muscle spasms

Insomnia

Lethargy

Mouth ulceration

Pain in extremity

Rash erythematous

Rash maculo-papular

Rash pruritic

Rhinorrhoea

Skin ulcer

Taste disorder

Ileus

Pneumonia

Arrhythmia

Cerebrovascular accident

Haemoptysis

Lung neoplasm malignant

Malignant pleural effusion

Pericardial effusion malignant

Metastases to meninges

Respiratory failure

Respiratory tract infection

Urinary tract obstruction

Pneumothorax

Sepsis

Pulmonary embolism

Spinal cord compression

100%

80%

60%

40%

20%

Study treatment Arm

Parts A and B: Midazolam + Mobocertinib

Trial Design

9Treatment groups

Experimental Treatment

Group I: Part 3: Extension CohortExperimental Treatment1 Intervention

TAK-788 treatment for participants with previously treated locally advanced or metastatic NSCLC whose tumors harbor EGFR exon 20 insertion mutations.

Group II: Part 2: Expansion Cohort 7Experimental Treatment1 Intervention

TAK-788 treatment for participants with solid tumors other than NSCLC with EGFR/HER2 mutations against which TAK-788 is active without active CNS metastases.

Group III: Part 2: Expansion Cohort 6Experimental Treatment1 Intervention

TAK-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

Group IV: Part 2: Expansion Cohort 5Experimental Treatment1 Intervention

TAK-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.

Group V: Part 2: Expansion Cohort 4Experimental Treatment1 Intervention

TAK-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.

Group VI: Part 2: Expansion Cohort 3Experimental Treatment1 Intervention

TAK-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.

Group VII: Part 2: Expansion Cohort 2Experimental Treatment1 Intervention

TAK-788 treatment for NSCLC participants with HER2 exon 20 activating insertions or point mutations and no active, measurable CNS metastases.

Group VIII: Part 2: Expansion Cohort 1Experimental Treatment1 Intervention

TAK-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.

Group IX: Part 1: Dose Escalation ComponentExperimental Treatment1 Intervention

TAK-788 treatment for participants with advanced NSCLC.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TAK-788

2019

Completed Phase 1

~140

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Millennium Pharmaceuticals, Inc.Lead Sponsor

404 Previous Clinical Trials

46,580 Total Patients Enrolled

TakedaLead Sponsor

1,202 Previous Clinical Trials

4,177,928 Total Patients Enrolled

Study DirectorStudy DirectorTakeda

1,207 Previous Clinical Trials

489,346 Total Patients Enrolled

Media Library

TAK-788 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02716116 — Phase 1 & 2

Non-Small Cell Lung Cancer Research Study Groups: Part 2: Expansion Cohort 7, Part 3: Extension Cohort, Part 1: Dose Escalation Component, Part 2: Expansion Cohort 1, Part 2: Expansion Cohort 2, Part 2: Expansion Cohort 3, Part 2: Expansion Cohort 4, Part 2: Expansion Cohort 5, Part 2: Expansion Cohort 6

Non-Small Cell Lung Cancer Clinical Trial 2023: TAK-788 Highlights & Side Effects. Trial Name: NCT02716116 — Phase 1 & 2

TAK-788 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02716116 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still available for this investigation?

"Per the source material found on clinicaltrials.gov, this trial is not presently open to recruitment. This study was initially posted June 16th 2016 and last edited November 17th 2022. At present, 2122 other studies are actively seeking participants for their respective trials."

Answered by AI

How many individuals are currently participating in this research initiative?

"This clinical trial is not accepting new participants at this juncture. It was posted on June 16th, 2016 and most recently updated on November 17th 2022. However, if you are looking for similar studies to join, there are presently 1360 trials recruiting patients with carcinoma non-small-cell lung cancer and 762 actively searching for volunteers taking TAK-788."

Answered by AI

How widely is this research endeavor being conducted?

"This medical trial is recruiting patients from Banner MD Anderson Cancer Center in Gilbert, North carolina; Levine Cancer Institute in Charlotte, Virginia; and University of Virginia Cancer Centre in Charlottesville. Additionally, there are 7 other enrolment centres located throughout the country."

Answered by AI

How is TAK-788 traditionally employed therapeutically?

"TAK-788 is indicated for first line treatment of certain conditions, including advanced thymoma, testicular cancer, carcinomas and neuroendocrine tumors."

Answered by AI

What other investigations have been conducted regarding TAK-788?

"TAK-788 was first investigated in 2002 at H Central de Asturias. This has led to 1047 completed trials, with 762 currently undergoing recruitment primarily from the Gilbert Medical Center in North carolina."

Answered by AI

Recent research and studies

egfrJournal

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

Riely, Gregory J., Joel W. Neal, D. Ross Camidge, Alexander I. Spira, Zofia Piotrowska, Daniel B. Costa, Anne S. Tsao, et al.. 2021. “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 Discovery. American Association for Cancer Research (AACR). doi:10.1158/2159-8290.cd-20-1598.

egfrJournal

Treatment Outcomes and Safety of Mobocertinib in Platinum-pretreated Patients with egfr Exon 20 Insertion–positive Metastatic Non–small Cell Lung Cancer

Zhou, Caicun, Suresh S. Ramalingam, Tae Min Kim, Sang-We Kim, James Chih-Hsin Yang, Gregory J. Riely, Tarek Mekhail, et al.. 2021. “Treatment Outcomes and Safety of Mobocertinib in Platinum-pretreated Patients with egfr Exon 20 Insertion–positive Metastatic Non–small Cell Lung Cancer”. JAMA Oncology. American Medical Association (AMA). doi:10.1001/jamaoncol.2021.4761.

her2Journal

Targeting her2 Exon 20 Insertion–mutant Lung Adenocarcinoma with a Novel Tyrosine Kinase Inhibitor Mobocertinib

Han, Han, Shuai Li, Ting Chen, Michael Fitzgerald, Shengwu Liu, Chengwei Peng, Kwan Ho Tang, et al.. 2021. “Targeting her2 Exon 20 Insertion–mutant Lung Adenocarcinoma with a Novel Tyrosine Kinase Inhibitor Mobocertinib”. Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/0008-5472.can-21-1526.

egfrJournal