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

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
   pointes.