NCT04129502

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 354 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The drug being tested in this study is called TAK-788. TAK-788 is being tested to evaluate the efficacy as a first line treatment compare with platinum-based chemotherapy in the participants with locally advanced or NSCLC whose tumors harbor EGFR exon 20 insertion mutations. The study will enroll approximately 318 patients. Participants will be randomly assigned to one of the two treatment groups- * TAK-788 Group (Arm A) * Platinum-based Chemotherapy Group (Arm B) The participants will be administered with TAK-788 orally in arm A and pemetrexed/cisplatin or pemetrexed/carboplatin intravenously (IV) in arm B until the participants experience progressive disease (PD) as assessed by blinded independent review committee (IRC), intolerable toxicity or another discontinuation criteria. Participants in the chemotherapy group may cross over to treatment with TAK-788 after IRC-assessed PD is documented. Randomized treatment with TAK-788 or platinum-based chemotherapy may be continued after PD, at the discretion of the investigator and with the sponsor's approval, if there is still evidence of clinical benefit. This multi-center trial will be conducted in United States (US), Europe, and Asia. The overall time to participate in this study is until 3 years after the last participant is randomized. Participants will make multiple visits to the clinic and will be followed for survival, subsequent anticancer therapy, subsequent disease assessment outcome until disease progression on a subsequent anticancer therapy, and participant-reported health status (EuroQoL-5 Dimensions-5 Levels \[EQ-5D-5L\]) for 3 years after the last participant is randomized in the study and 30 days after the last dose of study drug for safety follow-up.

Conditions

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

Interventions

Type	Name	Description
DRUG	TAK-788	TAK-788 capsule
DRUG	Pemetrexed	Pemetrexed IV infusion
DRUG	Cisplatin	Cisplatin IV infusion
DRUG	Carboplatin	Carboplatin IV infusion

Timeline

• Start date: 2020-01-10
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2019-10-16
• Last updated: 2026-03-30

Locations

134 sites across 24 countries: United States, Australia, Austria, Belgium, Canada, China, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Netherlands, Portugal, Russia, Singapore, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study