Loading
CheckMate 816 was the first trial to show that immunotherapy before lung cancer surgery improves survival.
CheckMate 816, trial NCT02998528 sponsored by Bristol Myers Squibb and reported in 2022, was the first trial to show that immunotherapy before lung cancer surgery improves survival. It randomised 358 patients with resectable stage IB to IIIA non-small-cell lung cancer to three cycles of nivolumab plus platinum chemotherapy or chemotherapy alone, met both primary endpoints of pathologic complete response and event-free survival, showed an overall survival benefit in a 2025 update, and produced the first neoadjuvant-only immunotherapy approval in 2022. OnCo links it to the pCR and perioperative terms, to Tina Cascone, Jonathan Spicer, Patrick M. Forde and Valerie W. Rusch, and its event-free survival benefit was reproduced by KEYNOTE-671, AEGEAN, CheckMate 77T and NEOTORCH. Whether adding an adjuvant phase after neoadjuvant treatment adds anything is the open question.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
358 randomised.
Step lines join published landmark estimates; the true curve between them is not shown.
Curves show the trial population; they are not a prediction for any one person.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Pathologic complete responseprimary | Nivolumab + chemotherapy | 179 | 24% | - | <0.001 | link |
| Chemotherapy | 179 | 2.2% | ||||
| Event-free survivalprimary | Nivolumab + chemotherapy | - | 31.6 months | 0.63 (0.43 to 0.91) | 0.005 | link |
| Chemotherapy | - | 20.8 months | ||||
| Overall survival at 5 years | Nivolumab + chemotherapy | - | 65% | 0.72 (0.52 to 0.99) | - | link |
| Chemotherapy | - | 55% |
A second publication from the CheckMate 816 trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
Patients with operable stage II-III lung cancer without EGFR or ALK alterations should have chemo-immunotherapy discussed before surgery rather than only afterwards. Three pre-operative cycles do not compromise the operation and improve cure rates. Whether to continue immunotherapy after surgery, as the perioperative trials do, and whether patients with pCR need any further treatment, remain open questions.
Shares Tina Cascone, KEYNOTE-091 (PEARLS), A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer, A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer.
Shares A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer, A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer, Pathologic complete response (pCR), Neoadjuvant / adjuvant / perioperative.
Shares CheckMate 816: three cycles of nivolumab plus chemotherapy before lung cancer surgery, Neoadjuvant / adjuvant / perioperative, Resectable stage I to III non-small-cell lung cancer, Nivolumab.
Shares A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer, CheckMate 816: three cycles of nivolumab plus chemotherapy before lung cancer surgery, Neoadjuvant / adjuvant / perioperative, Resectable stage I to III non-small-cell lung cancer.
Shares A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer, A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer, Resectable stage I to III non-small-cell lung cancer, Lung cancer (all types).
Shares Use pre-surgery immunotherapy windows as the field's biomarker engine, Pathologic complete response (pCR), Neoadjuvant / adjuvant / perioperative, Resectable stage I to III non-small-cell lung cancer.
Shares Use pre-surgery immunotherapy windows as the field's biomarker engine, Surgery roadmap: radical operations → less surgery → no surgery when a drug has done the work, Pathologic complete response (pCR), Neoadjuvant / adjuvant / perioperative.
Shares CheckMate 816: three cycles of nivolumab plus chemotherapy before lung cancer surgery, Neoadjuvant / adjuvant / perioperative, Resectable stage I to III non-small-cell lung cancer, Lung cancer (all types).