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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

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

Secondary outcome measures

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%

Blood creatinine increased

27%

Dyspepsia

23%

Dry skin

19%

Anaemia

19%

Weight decreased

19%

Cough

15%

Pruritus

15%

Mucosal inflammation

15%

Dermatitis acneiform

15%

Hypomagnesaemia

15%

Dizziness

15%

Urinary tract infection

15%

Stomatitis

15%

Epistaxis

15%

Alopecia

15%

Gastrooesophageal reflux disease

12%

Amylase increased

12%

Constipation

12%

Paronychia

12%

Dehydration

12%

Dyspnoea

12%

Headache

12%

Hyperkalaemia

12%

Lipase increased

12%

Musculoskeletal chest pain

Hypokalaemia

Pyrexia

Chills

Muscle spasms

Arthralgia

Dysgeusia

Hypercalcaemia

Hypophosphataemia

Insomnia

Lethargy

Pain in extremity

Rash erythematous

Rash pruritic

Rhinorrhoea

Skin ulcer

Taste disorder

Mouth ulceration

Hypertension

Acute kidney injury

Rash maculo-papular

Dry mouth

Abdominal pain

Angular cheilitis

Lung neoplasm malignant

Sepsis

Respiratory failure

Pneumonia

Cerebrovascular accident

Pulmonary embolism

Spinal cord compression

Pneumothorax

Ileus

Arrhythmia

Respiratory tract infection

Malignant pleural effusion

Haemoptysis

Metastases to meninges

Urinary tract obstruction

Pericardial effusion malignant

100%

80%

60%

40%

20%

Study treatment Arm

Parts A and B: Midazolam + Mobocertinib

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 / 4Eligibility criteria met