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CompletedPhase 3NCT04129502
Official study title

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

Study summary

The purpose of this study is to compare 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedTAK-788 and Pemetrexed

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 23, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?134 U.S. locations

Locations may change over time.

Who runs it?Takeda

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Takeda
Interventions being studied
Drug: TAK-788; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Locally advanced→Metastatic or stage IV→
Biomarkers
EGFR→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • City of Hope National Medical CenterLong Beach, California
  • University of California IrvineOrange, California
  • Stanford UniversityPalo Alto, California
  • AdventHealthOrlando, Florida
  • Northwestern UniversityChicago, Illinois
  • University of Maryland Greenebaum Cancer CenterBaltimore, Maryland
  • Beth Israel Deaconess Medical Center - 330 Brookline AveBoston, Massachusetts
  • Dana Farber Cancer InstituteBoston, Massachusetts
  • Massachusetts General HospitalBoston, Massachusetts
  • Sarah Cannon Cancer CenterNashville, Tennessee
  • University of Virginia Health SystemCharlottesville, Virginia
  • GenesisCare North ShoreSt Leonards, New South Wales

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 23, 2026. Always confirm current availability with the study team.

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