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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)

Must not have

Received a moderate or strong CYP4503A inhibitor or moderate or strong CYP3A inducer within 10 days prior to first dose of TAK-788

Previously received TAK-788

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken strong or moderate CYP3A affecting drugs in the last 10 days.

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I have previously been treated with TAK-788.

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I do not have active brain tumors, uncontrolled heart issues, severe infections, lung conditions, or am not pregnant or breastfeeding.

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I have not had major surgery in the last 4 weeks.

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I haven't taken cancer immunotherapy or similar treatments in the last 28 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2021 Phase 1 trial • 26 Patients • NCT04051827

96%

Diarrhoea

65%

Nausea

50%

Fatigue

50%

Decreased appetite

35%

Rash

35%

Vomiting

27%

Blood creatinine increased

27%

Dyspepsia

23%

Dry skin

19%

Weight decreased

19%

Anaemia

19%

Cough

15%

Urinary tract infection

15%

Gastrooesophageal reflux disease

15%

Mucosal inflammation

15%

Dermatitis acneiform

15%

Stomatitis

15%

Alopecia

15%

Epistaxis

15%

Dizziness

15%

Pruritus

15%

Hypomagnesaemia

12%

Dyspnoea

12%

Lipase increased

12%

Dehydration

12%

Hyperkalaemia

12%

Paronychia

12%

Musculoskeletal chest pain

12%

Amylase increased

12%

Headache

12%

Constipation

Rhinorrhoea

Angular cheilitis

Arthralgia

Rash maculo-papular

Rash erythematous

Mouth ulceration

Acute kidney injury

Chills

Skin ulcer

Pyrexia

Muscle spasms

Dysgeusia

Rash pruritic

Dry mouth

Pain in extremity

Abdominal pain

Hypercalcaemia

Taste disorder

Hypertension

Hypokalaemia

Hypophosphataemia

Insomnia

Lethargy

Malignant pleural effusion

Arrhythmia

Pneumonia

Pneumothorax

Cerebrovascular accident

Haemoptysis

Respiratory failure

Ileus

Lung neoplasm malignant

Pericardial effusion malignant

Sepsis

Respiratory tract infection

Urinary tract obstruction

Metastases to meninges

Pulmonary embolism

Spinal cord compression

100%

80%

60%

40%

20%

Study treatment Arm

Parts A and B: Midazolam + Mobocertinib

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 13Eligibility criteria met