TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations
NCT04129502Phase 3Completed
- Lead sponsor
- Takeda (Industry)
- Enrollment
- 354 (actual)
- Start date
- 10 Jan 2020
- Primary completion
- 22 Sep 2026 (actual)
- Study completion
- 22 Sep 2026
- Last update posted
- 23 Oct 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- None
- Arms
- 2
Interventions
- TAK-788 Drug
- Pemetrexed Drug
- Cisplatin Drug
- Carboplatin Drug
Conditions and primary outcome
- Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
Primary outcome
Progression Free Survival (PFS) as Assessed by Blinded Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (Up to approximately 40 months after the first participant is randomized)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
1 on PubMedFirst-Line Mobocertinib Versus Platinum-Based Chemotherapy in Patients With EGFR Exon 20 Insertion-Positive Metastatic Non-Small Cell Lung Cancer in the Phase III EXCLAIM-2 Trial.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025 May
PubMed 39879577 (opens in a new tab)DOI 10.1200/JCO-24-01269 (opens in a new tab)
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT04129502 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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