TAK-788 as First-line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

ID#: NCT04129502

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: January 06, 2020

End Date: November 30, 2024

Contact Information:
Takeda Study Registration Call Center
1-866-835-2233
Summary: The purpose of this study is to compare the efficacy 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 harbor epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
Eligibility:

Inclusion Criteria:

- Histologically or cytologically confirmed nonsquamous cell locally advanced not suitable for definitive therapy, recurrent, or metastatic (Stage IV) non-small cell lung cancer (NSCLC)

- Documented epithelial growth factor receptor (EGFR) in-frame exon 20 insertion mutation assessed by a clinical laboratory improvements amendment (CLIA)-certified (United States [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 HER2 mutations except EGFR mutations for which there are approved anti-EGFR 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 response evaluation criteria in solid tumors (RECIST) version 1.1

- Life expectancy ≥3 months

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion Criteria:

- Received prior systemic treatment for locally advanced or metastatic disease

- Received radiotherapy ≤14 days before randomization or has not recovered from radiotherapy-related toxicities

- Received a moderate or strong cytochrome P-450 (CYP)3A inhibitor or moderate or strong CYP3A inducer within 10 days before randomization

- 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