TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations (NCT04129502)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: City of Hope National Medical Center — Long Beach, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (134 Sites)
Showing the first 25 of 134 sites.
- City of Hope National Medical Center — Long Beach, California
- University of California Irvine — Orange, California
- Stanford University — Palo Alto, California
- AdventHealth — Orlando, Florida
- Northwestern University — Chicago, Illinois
- University of Maryland Greenebaum Cancer Center — Baltimore, Maryland
- Beth Israel Deaconess Medical Center - 330 Brookline Ave — Boston, Massachusetts
- Dana Farber Cancer Institute — Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts
- Sarah Cannon Cancer Center — Nashville, Tennessee
- University of Virginia Health System — Charlottesville, Virginia
- GenesisCare North Shore — St Leonards, New South Wales
- Princess Alexandra Hospital — Woolloongabba, Queensland
- Flinders Medical Centre — Bedford Park, South Australia
- Klinik Floridsdorf — Vienna,
- Cliniques Universitaires Saint-Luc — Brussels, Brussels Capital
- Grand Hopital de Charleroi asbl — Charleroi, Hainaut
- AZ Sint-Lucas — Aalst, Oost-Vlaanderen
- British Columbia Cancer Agency — Vancouver, British Columbia
- William Osler Health System — Brampton, Ontario
- Princess Margaret Hospital — Toronto, Ontario
- Hopital Du Sacre Coeur de Montreal — Montreal, Quebec
- Beijing Cancer Hospital - PPDS — Beijing, Beijing Municipality
- Henan Cancer Hospital — Zhengzhou, Henan
- Jilin Cancer Hospital — Changchun, Jilin
📞 Contact the Study Coordinator
Phone: (800) 826-4673
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.