Status:
ACTIVE_NOT_RECRUITING
TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations
Lead Sponsor:
Takeda
Conditions:
Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 lun...
Detailed Description
The drug being tested in this study is called TAK-788. TAK-788 is being tested to evaluate the efficacy as a first line treatment compare with platinum-based chemotherapy in the participants with loca...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2026
Estimated Enrollment :
354 Patients enrolled
Trial Details
Trial ID
NCT04129502
Start Date
January 10 2020
End Date
October 31 2026
Last Update
April 22 2025
Active Locations (134)
Enter a location and click search to find clinical trials sorted by distance.
1
City of Hope National Medical Center
Long Beach, California, United States, 90813
2
University of California Irvine
Orange, California, United States, 92868
3
Stanford University
Palo Alto, California, United States, 94304
4
AdventHealth
Orlando, Florida, United States, 32804