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Clinical Trials List

Protocol NumberTAK-788-3001
NCT Number(ClinicalTrials.gov Identfier)NCT04129502

2020-05-01 - 2025-05-31

Phase III

Recruiting9

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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

  • Trial Applicant

    PPD DEVELOPMENT (HK) LIMITED

  • Sponsor

    Millennium Pharmaceuticals, Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Chien-Chung Lin 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yuh-Min Chen Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 魏裕峰 Division of Thoracic Medicine
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 賴俊良 Division of Thoracic Medicine
Dalin Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳昭勳 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chung-Yu Chen Division of Thoracic Medicine
National Taiwan University Hospital Yunlin Branch 

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Gee-chen Chang Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Yu Hung Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

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

Objectives

To compare the efficacy of TAK-788 as first-line treatment with that of platinum-based chemotherapy in patients with locally advanced or metastatic NSCLC whose tumors harbor EGFR exon 20 insertion mutations, as evidenced by progression-free survival (PFS) as assessed by blinded independent review committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Test Drug

TAK-788 (AP32788)

Active Ingredient

TAK-788 (AP32788)

Dosage Form

Capsule

Dosage

40

Endpoints

To compare the efficacy of TAK-788 as first-line treatment with that of platinum-based chemotherapy in patients with locally advanced or metastatic NSCLC whose tumors harbor EGFR exon 20 insertion mutations, as evidenced by progression-free survival (PFS) as assessed by blinded independent review committee (IRC) per Response Evaluation Criteria in Solid Tumors
(RECIST) version 1.1.

Inclution Criteria

Main inclusion criteria:
• Male or female adult patients (aged 18 years or older, or as defined per local regulations).
• Histologically or cytologically confirmed locally advanced not suitable for definitive therapy, recurrent, or metastatic (Stage IV) NSCLC.
• A documented EGFR in-frame exon 20 insertion mutation (including A763_Y764insFQEA, V769_D770insASV, D770_N771insNPG, D770_N771insSVD, H773_V774insNPH, or any other in-frame exon 20 insertion mutation) assessed by a
Clinical Laboratory Improvements Amendment–certified (United States [US] sites) or an accredited (outside of the US) local laboratory. The local molecular testing reports may be required by the sponsor to confirm the exon 20 insertion mutation status. 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 EGFR tyrosine kinase inhibitors (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 in-frame exon 20 insertion mutation. Note: confirmation of central test positivity is not required before randomization.
• At least 1 measurable lesion per RECIST version 1.1. Previously irradiated lesions may not be used for target lesions, unless there is unambiguous radiological progression after radiotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Adequate organ and hematologic function, as determined by the following:
− Alanine aminotransferase/aspartate aminotransferase ≤2.5 times the upper limit of the normal range (ULN; ≤5 times the ULN is acceptable if liver metastases are present).
− Total serum bilirubin ≤1.5 times the ULN (≤3.0 times the ULN for patients with Gilbert syndrome or if liver metastases are present).
− Estimated creatinine clearance ≥45 mL/min (calculated by using the Cockcroft-Gault equation).
− Serum albumin ≥2 g/dL.
− Serum lipase ≤1.5 times the ULN.
− Serum amylase ≤1.5 times the ULN unless the increased serum amylase is due to salivary isoenzymes.
− Absolute neutrophil count ≥1500/μL.
− Platelets ≥100,000/μL.
− Hemoglobin ≥9 g/dL.

Exclusion Criteria

•Received prior systemic treatment for locally advanced or metastatic disease (with the exception 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. Palliative radiation administered outside the chest and brain, stereotactic radiosurgery, and stereotactic body radiotherapy are allowed up to 7 days before randomization.
• Received a moderate or strong cytochrome P-450 (CYP)3A inhibitor or moderate or strong CYP3A inducer within 10 days before randomization.
• Had major surgery within 28 days before randomization. Minor surgical procedures such as catheter placement or minimally invasive biopsies are allowed.
• Have been diagnosed with another primary malignancy other than NSCLC, except for adequately treated nonmelanoma skin cancer or cervical cancer in situ; definitively treated nonmetastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.
• Have known active brain metastases (have either previously untreated intracranial central nervous system [CNS] metastases or previously treated intracranial CNS metastases with radiologically documented new or progressing CNS lesions). Brain metastases are allowed if they have been treated with surgery and/or radiation and have been stable without requiring corticosteroids to control symptoms within 7 days before randomization and have no evidence of new or enlarging brain metastases.
• Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging) or leptomeningeal disease (symptomatic or asymptomatic).
• Currently being treated with medications known to be associated with the development of torsades de pointes.
• Currently have or have had a history of interstitial lung disease, radiation pneumonitis that required steroid treatment, or drug-related pneumonitis.
• Have an ongoing or active infection including, but not limited to, the requirement for intravenous antibiotics, or a known history of HIV. Testing for HIV is not required in the absence of history.

The Estimated Number of Participants

  • Taiwan

    19 participants

  • Global

    318 participants

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