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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05261399 | Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment | PHASE3 | ACTIVE NOT_RECRUITING | 345 | — | — | Aug 3, 2022 | Nov 23, 2026 | Apr 6, 2026 | 226 | United States, Argentina +27 |
| NCT03091192 | Savolitinib vs. Sunitinib in MET-driven PRCC. | PHASE3 | ACTIVE NOT_RECRUITING | 60 | — | — | Jul 25, 2017 | Dec 31, 2026 | Apr 14, 2026 | 59 | United States, Brazil +5 |
Defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause.
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): \>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of randomisation until the date of PD (defined by Recist 1.1 and confirmed by BICR) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression.
| Arm | Type | Description |
|---|---|---|
| Chemotherapy | ACTIVE_COMPARATOR | Pemetrexed (500 mg/m2) with either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles (Q3W) for 4 cycles, followed by pemetrexed maintenance (500 mg/m2) Q3W |
| Savolitinib + Osimertinib | EXPERIMENTAL | 300 mg savolitinib BID plus 80 mg osimertinib QD |
| Savolitinib | EXPERIMENTAL | See: intervention description |
| Sunitinib | ACTIVE_COMPARATOR | See: intervention description |
| Name | Type | Description |
|---|---|---|
| Savolitinib | DRUG | 300 mg savolitinib (3 × 100 mg tablets twice daily) Administrative route : oral |
| Osimertinib | DRUG | 80 mg osimertinib (1 × 80 mg tablet once daily) Administrative route : oral |
| Pemetrexed | DRUG | Pemetrexed (500 mg/m2) Administrative route : IV infusion |
| Cisplatin | DRUG | Cisplatin (75 mg/m2) Administrative route : IV infusion |
| Carboplatin | DRUG | Carboplatin (AUC5) Administrative route : IV infusion |
| Sunitinib | DRUG | 50 mg by mouth (PO) once daily (QD), with or w/o food, 4 weeks on/2weeks off |
Inclusion Criteria: * Provision of signed and dated written ICF prior to any mandatory and non-mandatory study-specific procedures, sampling and analyses. * Participant must be ≥18 years (≥ 19 years of age in South Korea) at the time of signing the informed consent. All genders are permitted. * His...