Trial Search Results

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

This study is designed to test the effectiveness and safety of TAK-788 as an initial treatment in patients with nonsquamous cell non–small cell lung cancer (NSCLC) with epithelial growth factor receptor (EGFR) exon 20 insertion mutations. The results in these patients will be compared with results in patients receiving standard of care chemotherapy (platinum-doublet chemotherapy).

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Takeda

Stanford Investigator(s):

Intervention(s):

  • Drug: TAK-788
  • Drug: Pemetrexed
  • Drug: Cisplatin
  • Drug: Carboplatin

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - 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

Exclusion Criteria:

   - 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 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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Richard A. Quick
650-723-2983
Recruiting