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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06456138 | Trametinib Plus Anlotinib Combined With Tislelizumab in KRAS-mutant NSCLC | PHASE1 | NOT YET_RECRUITING | 60 | — | — | Jul 1, 2024 | Dec 31, 2028 | Jun 13, 2024 | 1 | China |
recommended phase 2 dose
progression-free survival
| Arm | Type | Description |
|---|---|---|
| Trametinib + Anlotinib + Tislelizumab | EXPERIMENTAL | In Phase I, there are four treatment arms: anlotinib (6 mg) plus trametinib (1 mg) plus tislelizumab (200 mg, Q3W), anlotinib (6 mg) plus trametinib (2 mg) plus tislelizumab (200 mg, Q3W), anlotinib (8 mg) plus trametinib (1 mg) plus tislelizumab (200 mg, Q3W), and anlotinib (8 mg) plus trametinib (2 mg) plus tislelizumab (200 mg, Q3W). In Phase II, there is one treatment arm including trametinib (RP2D) plus anlotinib (RP2D) plus tislelizumab (200 mg, Q3W). |
| Name | Type | Description |
|---|---|---|
| Trametinib | DRUG | Trametinib will be administrated orally every day. |
| Anlotinib | DRUG | Anlotinib will be administrated orally from day 1 to day 14 per 21-day cycle. |
| Tislelizumab | DRUG | Tislelizumab will be administered at full dose (200mg, Q3W) on the patient who received the efficacy evaluation of stable disease (SD) or partial response (PR) or complete response (CR) after 2 cycles' treatment of trametinib plus anlotinib. |
Inclusion Criteria: 1. According to the 8th edition of the AJCC/UICC TNM staging system for NSCLC, patients with locally advanced (stage III B/III C), metastatic or recurrent (stage IV) NSCLC confirmed by histology or cytology who are unable to undergo surgery and radical concomitant radiochemother...