TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations
A Randomized Phase 3 Multicenter Open-Label Study to Compare the Efficacy of TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy in Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations
Other study identifiers
Sponsor study identifier
Secondary identifiers
REGISTRY · CCMO
REGISTRY · EudraCT
OTHER_GRANT · WHO
REGISTRY · jRCT
NIH
interventional
354
24 countries
134
Study Start
January 10, 2020
Actual (reported)Primary Completion
September 22, 2026
Actual (reported)Study Completion
September 22, 2026
Actual (reported)Brief 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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- completed
- Actual enrollment (reported)
- 354 participants
- Study completion date
September 22, 2026
Actual (reported)- Listed locations
- 24 countries · 134 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
October 7, 2019
Actual (reported)First Posted
October 16, 2019
Actual (reported)Study Start
January 10, 2020
Actual (reported)Primary Completion
September 22, 2026
Actual (reported)Study Completion
September 22, 2026
Actual (reported)
- Last Updated
- October 23, 2026
- Status Verified
- October 2026
- Last Update Submitted
- October 22, 2026