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


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Trial ID: NCT04129502


The purpose of this study is to compare the 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.

Official Title

A Randomized Phase 3 Multicenter Open-Label Study to Compare the Efficacy of TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy in Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations

Stanford Investigator(s)

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)


Inclusion Criteria:

   - 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 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 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


drug: TAK-788

drug: Pemetrexed

drug: Cisplatin

drug: Carboplatin


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Richard A. Quick

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