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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05894889 | Pembrolizumab and Chemotherapy Neoadjuvant/Adjuvant of NSCLC | PHASE2 | ACTIVE NOT_RECRUITING | 70 | — | — | Jan 30, 2024 | Aug 1, 2027 | Jul 23, 2025 | 2 | China |
pCR in eligible stage IIA-IIIB (N2) NSCLC participants (AJCC Version 8, no known sensitizing EGFR or ALK alterations) following neoadjuvant pembrolizumab plus chemotherapy
Post-treatment proportion of CXCL13+PD1+ CD8 T cells in all CD8 T cells in single cell RNA-seq data
| Arm | Type | Description |
|---|---|---|
| Pembrolizumab + Chemotherapy | EXPERIMENTAL | Non-squamous NSCLC: pembrolizumab 200mg as at least 30-minute IV infusion on Day 1, followed by pemetrexed at a dose of 500mg/m2 IV over 30 minutes or per institutional standard with Carboplatin at a dose of AUC 5 over 120 minutes or per institutional standard, of a 3-week treatment cycle, for up to 4 cycles. Squamous NSCLC: pembrolizumab 200mg as at least 30-minute IV infusion on Day 1, followed by nab-paclitaxel at a dose of 135mg/m2 IV over 30 minutes or per institutional standard with Carboplatin at a dose of AUC 5 over 120 minutes or per institutional standard, of a 3-week treatment cycle, for up to 4 cycles. Nab-paclitaxel will also be administered at the dose of 135mg/m2 for over 30 minutes IV infusion or per institutional standard on day 8 of each 3-week treatment cycle. |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab 200 mg IV infusion | BIOLOGICAL | Biological: Pembrolizumab 200 mg IV infusion Drug: nab-paclitaxel IV infusion Drug: Carboplatin IV infusion Drug: Pemetrexed IV infusion |
Inclusion Criteria: 1. Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of \[Stage II, IIIA or IIIB(N2) NSCLC (AJCC Version 8)\] will be enrolled in this study. Note: mixed cellularity tumors are allowed. tu...