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Extended the PACIFIC idea to people who could not have chemotherapy and radiotherapy at the same time, the majority in much of the world.
PACIFIC established consolidation immunotherapy after concurrent chemoradiotherapy, but a substantial proportion of patients with stage III disease cannot tolerate or cannot access concurrent treatment and receive the two sequentially instead. GEMSTONE-301 tested whether consolidation still works in that population. It randomised 381 of 564 screened patients 2:1 at 50 Chinese centres between August 2018 and December 2020 to sugemalimab, an anti-PD-L1 antibody, or placebo, stratified by performance status, whether chemoradiotherapy was concurrent or sequential, and radiotherapy dose.
At the March 2021 cutoff, with a median follow-up of 14.3 months on sugemalimab and 13.7 on placebo, blinded independently reviewed progression-free survival was significantly longer with sugemalimab: median 9.0 months (95 percent confidence interval 8.1 to 14.1) against 5.8 months.
The trial matters because it is the only phase 3 evidence for consolidation after sequential chemoradiotherapy, and because sugemalimab is approved in China for this indication. It has no marketing authorisation for stage III disease in the United Kingdom, where NICE TA798 covers durvalumab after platinum-based chemoradiation instead.
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.
381 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (blinded independent central review)primary | Sugemalimab | 255 | 9 months | - | - | link |
| Placebo | 126 | 5.8 months |
Shares PACIFIC, Unresectable stage III non-small-cell lung cancer, Durvalumab, PD-L1.
Shares PACIFIC, Unresectable stage III non-small-cell lung cancer, Chemoradiation (chemoradiotherapy, CRT), Durvalumab.
Shares Unresectable stage III non-small-cell lung cancer, Durvalumab, IMRT / IGRT (modern external beam), Immune checkpoint inhibitors.
Shares PACIFIC, Unresectable stage III non-small-cell lung cancer, Durvalumab, PD-L1.
Shares Sugemalimab, IMRT / IGRT (modern external beam), Immune checkpoint inhibitors.
Shares CStone Pharmaceuticals, Sugemalimab, Immune checkpoint inhibitors.
Shares Sugemalimab, Unresectable stage III non-small-cell lung cancer, Immune checkpoint inhibitors.
Shares Durvalumab, Lung cancer (all types), IMRT / IGRT (modern external beam), Immune checkpoint inhibitors.