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NCT04129502 · ClinicalTrials.gov registry record · Phase 3
TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations
A Phase 3 study of Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC), sponsored by Takeda.
- Active
- Registry status
- Phase 3
- Development phase
- 354
- Enrollment target
- 20
- Study locations
NCT04129502: Active Phase 3 study of Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC), sponsored by Takeda.
NCT04129502 is a Phase 3 study of Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) that is active but no longer recruiting, run by Takeda. The registered enrollment target is 354 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04129502, a Phase 3 study of Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC), is active but no longer recruiting, sponsored by Takeda.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 354 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare effectiveness of TAK-788 as first-line treatment with that of platinum-based chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors has epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Participants will be randomly assigned to one of the two treatment groups- TAK-788 group or Platinum-based chemotherapy group. Participants will receive TAK-788 orally and pemetrexed/cisplatin or pemetrexed/carboplatin via vein until the participants experience worsening disease (PD) as assessed by blinded independent review committee (IRC), intolerable harmful effects or another discontinuation criteria.
Primary Outcome
PFS is defined as the time interval from the date of randomization until the first date at which the criteria for progressive disease (PD) according to RECIST Version 1.1 are met or death, whichever occurs first.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Pemetrexed
- DRUG TAK-788
Study Locations (20)
California
- City of Hope National Medical Center - Long Beach
- University of California Irvine - Orange
- Stanford University - Palo Alto
Massachusetts
- Beth Israel Deaconess Medical Center - 330 Brookline Ave - Boston
- Dana Farber Cancer Institute - Boston
- Massachusetts General Hospital - Boston
Florida
- AdventHealth - Orlando
Illinois
- Northwestern University - Chicago
Maryland
- University of Maryland Greenebaum Cancer Center - Baltimore
Tennessee
- Sarah Cannon Cancer Center - Nashville
Virginia
- University of Virginia Health System - Charlottesville
New South Wales
- GenesisCare North Shore - St Leonards
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 354 participants |
| Start Date | 2020-01-10 |
| Est. Completion | 2026-10-31 |
| Phase | Phase 3 |
What the registry record for NCT04129502 still lists
NCT04129502 is an interventional study that assigns participants to a tested intervention. The registered 354 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.
NCT04129502 names 20 study sites across 16 states, led by California, Massachusetts, Florida.
Frequently Asked Questions
What is clinical trial NCT04129502 about?
NCT04129502 is a clinical study titled "TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations". The purpose of this study is to compare effectiveness of TAK-788 as first-line treatment with that of platinum-based chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors has epidermal growth factor receptor (EGFR) exon 20 insertion mutation...
What is the current status of trial NCT04129502?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 354 participants. The study started on 2020-01-10. Estimated completion is 2026-10-31.
What conditions does trial NCT04129502 study?
This clinical trial studies the following conditions: Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC).
What interventions are being tested in trial NCT04129502?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Pemetrexed (DRUG), TAK-788 (DRUG).
Who is sponsoring clinical trial NCT04129502?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04129502 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04129502's enrollment target sits among peer trials
354 1026th of 2000 higher than 973 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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