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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 April 2024
• Main ID: NCT04129502
• Date of registration: 07/10/2019
• Prospective Registration: Yes
• Primary sponsor: Takeda
• Public title: TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations
• Scientific 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
• Date of first enrolment: January 10, 2020
• Target sample size: 354
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04129502
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Canada, China, Denmark, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Korea, Republic of, Netherlands, Portugal, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Study Director
• Affiliation: Takeda

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

Intervention(s)

Drug: Cisplatin

Drug: Carboplatin

Drug: Pemetrexed

Drug: TAK-788

Primary Outcome(s)

Progression Free Survival (PFS) as Assessed by Blinded Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [Time Frame: Up to approximately 40 months after the first participant is randomized]

Secondary Outcome(s)

Disease Control Rate (DCR) as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator [Time Frame: Up to approximately 40 months after the first participant is randomized]

Confirmed Objective Response Rate (ORR) as Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1 [Time Frame: Up to approximately 40 months after the first participant is randomized]

Time to Response, as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator [Time Frame: Up to approximately 40 months after the first participant is randomized]

Overall Survival (OS) [Time Frame: Up to approximately 40 months after the first participant is randomized]

Confirmed Objective Response Rate (ORR) as Assessed by the Investigator [Time Frame: Up to approximately 40 months after the first participant is randomized]

Participant-reported Symptoms as Assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire, Lung Cancer Module (QLQ-LC13) [Time Frame: Up to approximately 40 months after the first participant is randomized]

Progression Free Survival (PFS) as Assessed by the Investigator [Time Frame: Up to approximately 40 months after the first participant is randomized]

Duration of Response, as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator [Time Frame: Up to approximately 40 months after the first participant is randomized]

Patient-reported Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 [Time Frame: Up to approximately 40 months after the first participant is randomized]

Secondary ID(s)

NL20191212

jRCT2071210098

TAK-788-3001

2019-001845-42

U1111-1232-6059

Source(s) of Monetary Support

Please refer to primary and secondary sponsors