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Alkylating agents

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

Q: What is the common purpose of TAK-788?

<p>TAK-788 is most often used to treat <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>. However, it has also shown efficacy against metastatic ureter urothelial carcinoma, <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a>, non-hodgkin's lymphoma, and other malignant neoplasms.</p>

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%

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

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

Find a Location

Who is running the clinical trial?

Millennium Pharmaceuticals, Inc.Lead Sponsor

404 Previous Clinical Trials

46,560 Total Patients Enrolled

TakedaLead Sponsor

1,202 Previous Clinical Trials

4,177,908 Total Patients Enrolled

Medical DirectorStudy DirectorMillennium Pharmaceuticals, Inc.

2,777 Previous Clinical Trials

8,063,126 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04129502 — Phase 3

Lung Cancer Research Study Groups: Platinum-based Chemotherapy Group (Arm B), TAK-788 Group (Arm A)

Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04129502 — Phase 3

Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04129502 — Phase 3

Frequently Asked Questions

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

When might TAK-788 be available for general use?

"TAK-788 has received a safety score of 3. This is because there is evidence from past clinical trials to support its efficacy as well as multiple rounds of data supporting its safety."

Answered by AI

Are there any other instances where TAK-788 has been trialed before?

"TAK-788 was first studied in 1997, and there have been 1776 completed trials since then. According to current data, 1213 live trials are being conducted, with a significant portion taking place in Orlando, Florida."

Answered by AI

Could you provide a ballpark estimate for how many hospitals are testing this new treatment?

"21 different medical sites are participating in this trial, which makes it easier for patients to enroll. For example, there are centres located in Orlando, Long Beach and Charlotte. It is important to pick the site that is closest to your location to reduce travel time if you do decide to enroll."

Answered by AI

Can people sign up for this experiment right now?

"This study, which is actively recruiting patients, was first posted on clinicaltrials.gov on 1/10/2020 and most recently updated on 8/2/2022."

Answered by AI

What is the common purpose of TAK-788?

"TAK-788 is most often used to treat melanoma. However, it has also shown efficacy against metastatic ureter urothelial carcinoma, lymphoma, non-hodgkin's lymphoma, and other malignant neoplasms."

Answered by AI

How many test subjects are needed for this experiment?

"The sponsor, Millennium Pharmaceuticals, Inc., needs to recruit 318 patients that meet the clinical trial's inclusion criteria from different locations including AdventHealth in Orlando, Florida and Pacific Shores Medical Group in Long Beach, California."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

2020. "TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04129502.

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