CheckMate 77T
Neoadjuvant nivolumab plus chemotherapy followed by surgery and adjuvant nivolumab versus neoadjuvant chemotherapy plus placebo in resectable non-small-cell lung cancer
Phase 3NCT04025879
- Population
- Adults with resectable stage IIA to IIIB non-small-cell lung cancer
- Design
- Randomised, double-blind phase 3 trial. Neoadjuvant nivolumab plus chemotherapy or chemotherapy plus placebo every 3 weeks for 4 cycles, followed by surgery and adjuvant nivolumab or placebo every 4 weeks for 1 year.
- Primary endpoint
- EFS
- Arms
- Nivolumab plus chemotherapy (experimental): Neoadjuvant nivolumab plus chemotherapy for 4 cycles, surgery, then adjuvant nivolumab for 1 year
- Chemotherapy plus placebo (control): Neoadjuvant chemotherapy plus placebo for 4 cycles, surgery, then adjuvant placebo for 1 year
- People
- Cascone T, CheckMate 77T Investigators
EFSHR 0.58Δ 18-month EFS+20.2 pointsΔ pCR+20.6 pointsΔ MPR+23.3 points
Show the numbers
| Endpoint | Analysis | Nivolumab plus chemotherapy | Chemotherapy plus placebo | Effect |
|---|---|---|---|---|
| EFSRandomised patientsTime to disease progression or recurrence, abandoned surgery, or death, assessed by blinded independent review | interimmedian follow-up 25.4 monthsCascone 2024 | 70.2% at 18 mo | 50% at 18 mo | HR 0.58P<0.001Primary endpoint. The abstract reports the hazard ratio as 0.58 with a 97.36% CI of 0.42 to 0.81, so no ci95 is entered. |
| pCRRandomised patients | interimCascone 2024 | 25.3% | 4.7% | Secondary endpoint. Odds ratio 6.64 (95% CI 3.40 to 12.97). Grade 3 or 4 treatment-related adverse events: 32.5% vs 25.2%. |
| MPRRandomised patients | interimCascone 2024 | 35.4% | 12.1% | Secondary endpoint. Odds ratio 4.01 (95% CI 2.48 to 6.49). |
| Endpoint | Analysis | Nivolumab plus chemotherapy | Chemotherapy plus placebo | Effect |
|---|---|---|---|---|
| EFSRandomised patientsTime to disease progression or recurrence, abandoned surgery, or death, assessed by blinded independent review | interimmedian follow-up 25.4 monthsCascone 2024 | 70.2% at 18 mo | 50% at 18 mo | HR 0.58P<0.001Primary endpoint. The abstract reports the hazard ratio as 0.58 with a 97.36% CI of 0.42 to 0.81, so no ci95 is entered. |
| pCRRandomised patients | interimCascone 2024 | 25.3% | 4.7% | Secondary endpoint. Odds ratio 6.64 (95% CI 3.40 to 12.97). Grade 3 or 4 treatment-related adverse events: 32.5% vs 25.2%. |
| MPRRandomised patients | interimCascone 2024 | 35.4% | 12.1% | Secondary endpoint. Odds ratio 4.01 (95% CI 2.48 to 6.49). |