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Alkylating agents

TAK-788 vs Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer

Phase 3

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

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Adequate tumor tissue available, either from primary or metastatic sites, for central laboratory confirmation of EGFR exon 20 insertion mutation

Must not have

Taking medication(s) known to be associated with the development of torsades de pointes.

Have current spinal cord compression or leptomeningeal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 40 months after the first participant is randomized

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial will compare the effectiveness of TAK-788 to platinum-based chemotherapy in participants with NSCLC whose tumors have EGFR exon 20 insertion mutations.

Who is the study for?

Adults with advanced non-squamous NSCLC and specific EGFR exon 20 mutations, who haven't had systemic treatment for advanced disease. They should have a life expectancy of at least 3 months, an ECOG performance status of 0-1, adequate organ function, and no other primary malignancies or conditions like spinal cord compression.

What is being tested?

The trial is testing the effectiveness of TAK-788 taken orally against platinum-based chemotherapy (pemetrexed with cisplatin or carboplatin) given intravenously in patients with certain genetic mutations in their lung cancer. Participants are randomly assigned to one of these treatments.

What are the potential side effects?

TAK-788 may cause side effects such as diarrhea, rash, nausea; while platinum-based chemotherapies can lead to nerve damage (neuropathy), kidney problems, hearing issues, and increased risk of infections due to lowered blood cell counts.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

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I have enough tumor tissue for testing the EGFR exon 20 mutation.

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My cancer has a specific EGFR mutation not targeted by current treatments.

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My lung cancer is advanced and not suitable for surgery or radiation aimed at cure.

Exclusion Criteria

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

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I am on medication that could affect my heart rhythm.

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I have spinal cord compression or cancer spread to the lining of my brain.

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I have been diagnosed with a cancer type other than non-small cell lung cancer.

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I have not received a live vaccine in the last 4 weeks.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 40 months after the first participant is randomized

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 40 months after the first participant is randomized

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 40 months after the first participant is randomized for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS) as Assessed by Blinded Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Secondary study objectives

Confirmed Objective Response Rate (ORR) as Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1

Confirmed Objective Response Rate (ORR) as Assessed by the Investigator

Disease Control Rate (DCR) as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator

+6 more

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%

Dyspepsia

27%

Blood creatinine increased

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%

Lipase increased

12%

Dehydration

12%

Dyspnoea

12%

Hyperkalaemia

12%

Constipation

12%

Paronychia

12%

Musculoskeletal chest pain

12%

Amylase increased

12%

Headache

Dry mouth

Angular cheilitis

Arthralgia

Rash maculo-papular

Mouth ulceration

Chills

Taste disorder

Skin ulcer

Pain in extremity

Rash erythematous

Muscle spasms

Pyrexia

Rhinorrhoea

Dysgeusia

Rash pruritic

Acute kidney injury

Abdominal pain

Hypercalcaemia

Hypertension

Hypokalaemia

Hypophosphataemia

Insomnia

Lethargy

Pericardial effusion malignant

Pulmonary embolism

Cerebrovascular accident

Arrhythmia

Pneumonia

Pneumothorax

Spinal cord compression

Respiratory failure

Ileus

Haemoptysis

Lung neoplasm malignant

Malignant pleural effusion

Respiratory tract infection

Sepsis

Urinary tract obstruction

Metastases to meninges

100%

80%

60%

40%

20%

Study treatment Arm

Parts A and B: Midazolam + Mobocertinib

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TAK-788 Group (Arm A)Experimental Treatment1 Intervention

TAK-788 160 milligram (mg) with or without food, capsules, orally, once daily until the participants experience PD as assessed by blinded IRC, intolerable toxicity, or another discontinuation criteria.

Group II: Platinum-based Chemotherapy Group (Arm B)Active Control3 Interventions

Pemetrexed 500 milligram per meter square (mg/m\^2) plus cisplatin 75 mg/m\^2, infusion, IV, once on Day 1 of 21-day cycle pemetrexed 500 mg/m\^2 plus carboplatin, infusion, IV, once at a dose calculated to produce area under curve (AUC) of 5 milligram\*minute per milliliter (mg\*min/mL) on Day 1 of 21-day cycle until the participants experience PD as assessed by blinded IRC, intolerable toxicity, or another discontinuation criteria. Pemetrexed/cisplatin or pemetrexed/carboplatin will be repeated every 3 weeks for 4 cycles, followed by maintenance treatment with pemetrexed 500 mg/m\^2, on Day 1 of a 21-day cycle thereafter.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TAK-788

2019

Completed Phase 1

~140

0 / 9Eligibility criteria met