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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05015608 | Study on Savolitinib Combined With Osimertinib in Treatment of Advanced NSCLC With MET Amplification | PHASE3 | COMPLETED | 216 | — | — | Nov 22, 2021 | Aug 22, 2025 | May 27, 2026 | 1 | China |
| NCT05009836 | Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC | PHASE3 | ACTIVE NOT_RECRUITING | 320 | — | — | Sep 6, 2021 | Aug 30, 2026 | Aug 29, 2025 | 1 | China |
Progression-free survival (PFS) using Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
| Arm | Type | Description |
|---|---|---|
| Savolitinib + Osimertinib | EXPERIMENTAL | Savolitinib orally once per day (QD) + Osimertinib orally QD,21day cycles (every 3 weeks) |
| Pemetrexed combined with platinum | ACTIVE_COMPARATOR | Pemetrexed combined with platinumon on Day 1 of 21day cycles (every 3 weeks) |
| Savolitinib | EXPERIMENTAL | Savolitinib 600 mg or 400 mg QD orally +Osimertinib 80 mg QD orally ( every 3 weeks) |
| placebo | PLACEBO_COMPARATOR | placebo 600 mg or 400 mg QD orally+ Osimertinib 80 mg QD orally ( every 3 weeks) |
| Name | Type | Description |
|---|---|---|
| Savolitinib + Osimertinib | DRUG | Subjects will receive Savolitinib orally once per day (QD) + Osimertinib orally QD,21day cycles (every 3 weeks) until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent. |
| Pemetrexed + Cisplatin /Carboplatin | DRUG | Pemetrexed combined with platinumon on Day 1 of 21day cycles (every 3 weeks) |
| Savolitinib | DRUG | Subjects will receive Savolitinib orally once per day (QD) + Osimertinib orally QD,21day cycles (every 3 weeks) until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent. |
| Placebo | DRUG | Subjects will receive placebo orally once per day (QD) + Osimertinib orally QD,21day cycles (every 3 weeks) until disease progression, death, adverse |
Inclusion Criteria: 1. Fully aware this study and voluntary to sign the informed consent form, and willing and able to comply with the study procedure; 2. Age ≥ 18 and ≤75 years; 3. In accordance with the 8th Edition of TNM staging for lung cancers by International Association for the Study of Lung...