TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations
Running, not enrolling · Phase 3
Conditions studied: Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
In brief
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.
Key facts
- Study ID
- NCT04129502
- Run by
- Takeda
- People needed
- 354
- Starts
- 2020-01-10
- Expected to finish
- 2026-10-31
- Last updated by the study team
- 2026-03-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female adult patients (aged 18 years or older)
- Histologically or cytologically confirmed nonsquamous cell locally advanced not suitable for definitive therapy, recurrent, or metastatic (Stage IV) NSCLC
- Documented epidermal growth factor receptor (EGFR) in-frame exon 20 insertion mutation assessed by a clinical laboratory improvements amendment (CLIA)-certified (US sites) or an accredited (outside of the US) local laboratory The EGFR exon 20 insertion mutation can be either alone or in combination with other EGFR or human epidermal growth factor receptor 2 (HER2) mutations except EGFR mutations for which there are approved anti-EGFR tyrosine kinase inhibitors [TKIs] (ie, exon 19 del, L858R, T790M, L861Q, G719X, or S768I, where X is any other amino acid)
- Adequate tumor tissue available, either from primary or metastatic sites, for central laboratory confirmation of EGFR exon 20 insertion mutation
- At least 1 measurable lesion per RECIST Version 1.1
- Life expectancy ≥3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Adequate organ and hematologic function as defined by blood transfusions with a recommended >/ 14 day washout period.
You may not qualify if…
- Received prior systemic treatment for locally advanced or metastatic disease, including local administration, such as intra-pleural injection of anticancer medication with the exception noted below:
- Neoadjuvant or adjuvant chemotherapy/immune therapy for Stage I to III or combined modality chemotherapy/radiation for locally advanced disease is allowed if completed >6 months before the development of metastatic disease.
- Received radiotherapy ≤14 days before randomization or has not recovered from radiotherapy-related toxicities
- Received a moderate or strong cytochrome P450 (CYP)3A inhibitor or moderate or strong CYP3A inducer within 10 days before first dose of TAK-788
- Have been diagnosed with another primary malignancy other than NSCLC
- Have current spinal cord compression or leptomeningeal disease
- Have uncontrolled hypertension. Participants with hypertension should be under treatment on study entry to control blood pressure
- Received a live vaccine within 4 weeks before randomization per Summary of product characteristics (SmPCs) for pemetrexed, cisplatin, and carboplatin
- Taking medication(s) known to be associated with the development of torsades de pointes.
Where it is running
- University of California Irvine — Orange, California, United States
- Stanford University — Palo Alto, California, United States
- AdventHealth — Orlando, Florida, United States
- Northwestern University — Chicago, Illinois, United States
- University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States
- Beth Israel Deaconess Medical Center - 330 Brookline Ave — Boston, Massachusetts, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Sarah Cannon Cancer Center — Nashville, Tennessee, United States
- University of Virginia Health System — Charlottesville, Virginia, United States
- GenesisCare North Shore — St Leonards, New South Wales, Australia
- Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
- Flinders Medical Centre — Bedford Park, South Australia, Australia
- Klinik Floridsdorf — Vienna, Austria
- Cliniques Universitaires Saint-Luc — Brussels, Brussels Capital, Belgium
- Grand Hopital de Charleroi asbl — Charleroi, Hainaut, Belgium
- AZ Sint-Lucas — Aalst, Oost-Vlaanderen, Belgium
- British Columbia Cancer Agency — Vancouver, British Columbia, Canada
- William Osler Health System — Brampton, Ontario, Canada
- Princess Margaret Hospital — Toronto, Ontario, Canada
- Hopital Du Sacre Coeur de Montreal — Montreal, Quebec, Canada
- Beijing Cancer Hospital - PPDS — Beijing, Beijing Municipality, China
- Henan Cancer Hospital — Zhengzhou, Henan, China
- Jilin Cancer Hospital — Changchun, Jilin, China
- City of Hope National Medical Center — Long Beach, California, United States
Full record on ClinicalTrials.gov
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