# GEMSTONE-302

Source: https://onco.cc/trials/gemstone-302/  
OnCo record `gemstone-302` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The trial behind sugemalimab's approval in China and later Europe, showing a PD-L1 antibody plus chemotherapy delays progression in both main types of lung cancer.

## Summary

479 patients randomised 2:1. Median progression-free survival 7.8 versus 4.9 months (hazard ratio 0.50) at the interim analysis, with benefit in squamous and non-squamous histology and across PD-L1 levels; overall survival favoured sugemalimab at the final analysis. NMPA approval December 2021; European Commission approval July 2024, the first EU approval of a Chinese-developed PD-L1 antibody.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-10
- Tags: china
- Registry id: NCT03789604
- Phase: 3
- Setting: First-line metastatic squamous and non-squamous NSCLC without EGFR, ALK, ROS1 or RET alterations, China: sugemalimab or placebo plus platinum chemotherapy
- Sponsor: CStone Pharmaceuticals
- Enrolled: 479
- Result: PFS 7.8 vs 4.9 months, HR 0.50.
- Outcomes: Progression-free survival: Sugemalimab + chemotherapy 7.8 months vs Placebo + chemotherapy 4.9 months, HR 0.5

## Sources

- ClinicalTrials.gov NCT03789604: https://clinicaltrials.gov/study/NCT03789604
- Lancet Oncol 2022: https://doi.org/10.1016/S1470-2045(21)00650-1

## Connected records

- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Sugemalimab](https://onco.cc/drugs/sugemalimab/)
- companies: [CStone Pharmaceuticals](https://onco.cc/companies/cstone/)
- people: [Caicun Zhou](https://onco.cc/people/zhou-caicun/)
- key papers: [Interim survival analysis of the randomized phase III GEMSTONE-302 trial: sugemalimab or placebo plus chemotherapy as first-line treatment for metastatic NSCLC](https://onco.cc/key-papers/paper-gemstone-302-nat-cancer-2023-update/), [Sugemalimab versus placebo, in combination with platinum-based chemotherapy, as first-line treatment of metastatic non-small-cell lung cancer (GEMSTONE-302): interim and final analyses of a double-blind, randomised, phase 3 clinical trial](https://onco.cc/key-papers/paper-gemstone-302-lancet-oncol-2022/)

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