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Alkylating agents
TAK-788 vs Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer
Beijing, China
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
No Placebo-Only Group
Pivotal Trial
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.
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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 belowSelect...
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.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
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.
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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
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 moreSide effects data
From 2021 Phase 1 trial • 26 Patients • NCT0405182796%
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%
Hypomagnesaemia
15%
Mucosal inflammation
15%
Epistaxis
15%
Gastrooesophageal reflux disease
15%
Pruritus
15%
Urinary tract infection
15%
Alopecia
15%
Stomatitis
15%
Dermatitis acneiform
15%
Dizziness
12%
Constipation
12%
Amylase increased
12%
Dyspnoea
12%
Headache
12%
Musculoskeletal chest pain
12%
Paronychia
12%
Dehydration
12%
Lipase increased
12%
Hyperkalaemia
8%
Acute kidney injury
8%
Arthralgia
8%
Hypophosphataemia
8%
Mouth ulceration
8%
Muscle spasms
8%
Insomnia
8%
Lethargy
8%
Pain in extremity
8%
Pyrexia
8%
Rash erythematous
8%
Rash maculo-papular
8%
Taste disorder
8%
Abdominal pain
8%
Angular cheilitis
8%
Dry mouth
8%
Dysgeusia
8%
Rash pruritic
8%
Rhinorrhoea
8%
Skin ulcer
8%
Chills
8%
Hypercalcaemia
8%
Hypertension
8%
Hypokalaemia
4%
Pulmonary embolism
4%
Respiratory failure
4%
Respiratory tract infection
4%
Pneumothorax
4%
Metastases to meninges
4%
Sepsis
4%
Spinal cord compression
4%
Urinary tract obstruction
4%
Pericardial effusion malignant
4%
Pneumonia
4%
Arrhythmia
4%
Haemoptysis
4%
Ileus
4%
Cerebrovascular accident
4%
Lung neoplasm malignant
4%
Malignant pleural effusion
100%
80%
60%
40%
20%
0%
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.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
Find a Location
Closest Location:University of Virginia Health System· Charlottesville, VA
Who is running the clinical trial?
Millennium Pharmaceuticals, Inc.Lead Sponsor
405 Previous Clinical Trials
46,512 Total Patients Enrolled
TakedaLead Sponsor
1,253 Previous Clinical Trials
4,218,875 Total Patients Enrolled
Medical DirectorStudy DirectorMillennium Pharmaceuticals, Inc.
2,966 Previous Clinical Trials
8,098,511 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,315 Previous Clinical Trials
572,820 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I have high blood pressure that is not well-controlled.I am 18 years old or older.I am on medication that could affect my heart rhythm.I have spinal cord compression or cancer spread to the lining of my brain.I have enough tumor tissue for testing the EGFR exon 20 mutation.I have been diagnosed with a cancer type other than non-small cell lung cancer.I have not received a live vaccine in the last 4 weeks.You have at least one visible and measurable abnormality according to specific guidelines.My cancer has a specific EGFR mutation not targeted by current treatments.My blood counts are within normal ranges without transfusions for over 14 days.You are expected to live for at least 3 more months.I've had treatment for cancer that had spread, but it was over 6 months ago.My lung cancer is advanced and not suitable for surgery or radiation aimed at cure.I haven't taken strong or moderate CYP3A affecting drugs in the last 10 days.I had radiotherapy less than 14 days ago or am still experiencing side effects.
Research Study Groups:
This trial has the following groups:- Group 1: Platinum-based Chemotherapy Group (Arm B)
- Group 2: TAK-788 Group (Arm A)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.