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:

Millennium Pharmaceuticals, Inc.

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) 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

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