Table 3.
Ongoing Randomized Phase III Trials Of Neoadjuvant Immunotherapy In Early-Stage And Locally Advanced NSCLC
| Eligible Patients | Intervention | Estimated Enrollment | The Primary Endpoint | ||
|---|---|---|---|---|---|
| ChekMate816 (NCT02998528) |
Resectable stage IB-IIIA NSCLC | Arm A: nivolumab+ipilimumab×3 cycles→Surgery→CT±RT | N=642 | EFS pCR |
[40] |
| Arm B: platinum doublet×3 cycles→Surgery→CT±RT | |||||
| Arm C: nivolumab+platinum doublet×3 cycles→Surgery→CT±RT | |||||
| IMpower030 (NCT03456063) |
Resectable stage II, IIIA, select IIIB NSCLC | Arm A: atezolizumab+ platinum doublet×4 cycles→Surgery→atezolizumab | N=302 | MPR EFS |
[41] |
| Arm B: placebo+platinum doublet×4 cycles→Surgery→placebo | |||||
| KEYNOTE671 (NCT03425643) |
Stage IIB-IIIA NSCLC | Arm A: pembrolizumab+ platinum doublet×4 cycles→Surgery→pembrolizumab Arm B: placebo+platinum doublet×4 cycles→Surgery→placebo |
N=786 | EFS OS |
[42] |
Notes: MPR is defined as ≤ 10% residual viable tumor at the time of surgical resection, as assessed by central pathology laboratory.
Abbreviations: NSCLC, non-small-cell lung cancer; NCT, National Clinical Trials; CT, chemotherapy; RT, radiation therapy; EFS, Event Free Survival; pCR, Pathological Complete Response; OS, Overall Survival; MPR, Major pathological response.