Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04129502 | TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations | PHASE3 | ACTIVE NOT_RECRUITING | 354 | — | — | Jan 10, 2020 | Oct 31, 2026 | Mar 30, 2026 | 134 | United States, Australia +22 |
PFS is defined as the time interval from the date of randomization until the first date at which the criteria for progressive disease (PD) according to RECIST Version 1.1 are met or death, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| TAK-788 Group (Arm A) | EXPERIMENTAL | TAK-788 160 milligram (mg) with or without food, capsules, orally, once daily until the participants experience PD as assessed by blinded IRC, intolerable toxicity, or another discontinuation criteria. |
| Platinum-based Chemotherapy Group (Arm B) | ACTIVE_COMPARATOR | Pemetrexed 500 milligram per meter square (mg/m\^2) plus cisplatin 75 mg/m\^2, infusion, IV, once on Day 1 of 21-day cycle pemetrexed 500 mg/m\^2 plus carboplatin, infusion, IV, once at a dose calculated to produce area under curve (AUC) of 5 milligram\*minute per milliliter (mg\*min/mL) on Day 1 of 21-day cycle until the participants experience PD as assessed by blinded IRC, intolerable toxicity, or another discontinuation criteria. Pemetrexed/cisplatin or pemetrexed/carboplatin will be repeated every 3 weeks for 4 cycles, followed by maintenance treatment with pemetrexed 500 mg/m\^2, on Day 1 of a 21-day cycle thereafter. |
| Name | Type | Description |
|---|---|---|
| TAK-788 | DRUG | TAK-788 capsule |
| Pemetrexed | DRUG | Pemetrexed IV infusion |
| Cisplatin | DRUG | Cisplatin IV infusion |
| Carboplatin | DRUG | Carboplatin IV infusion |
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 exo...