Building Real-World Evidence in China

AstraZeneca PLC (AZN) is conducting the DREAM study in China, involving 200 patients with locally advanced small cell lung cancer (LS-SCLC). NCT07161388, a prospective, multi-center, single-cohort observational study, commenced on November 17, 2025, and is currently recruiting, with updates as of June 24, 2026. Twenty-one institutions in China are participating. The study aims to complete enrollment by September 30, 2028, and will evaluate patients who have received platinum-based concurrent or sequential chemoradiotherapy (CRT) and have not experienced disease progression. Physicians will prescribe Imfinzi at their discretion. The study focuses on understanding how factors such as patient selection, radiation modality, and access to treatment in the Chinese healthcare setting impact real-world outcomes, rather than comparing it to a randomized controlled trial.

Drug and Clinical Design

Imfinzi (durvalumab) is a monoclonal antibody that blocks programmed death-ligand 1 (PD-L1). As a non-interventional observational study evaluating a marketed drug, it does not fall under Phase 1, 2, or 3 classifications. The primary endpoint is the median real-world progression-free survival (rwPFS) observed over a maximum of 36 months. Overall survival (OS), time to treatment discontinuation (TTD), time to first subsequent anti-cancer therapy (TFST), and sites of progression will also be measured. Treatment-related adverse events, serious adverse events, and immune-related adverse events will be collected to validate the efficacy and safety differences between controlled clinical trials and routine clinical practice.

Established Regulatory Basis

In the global Phase 3 ADRIATIC trial, durvalumab maintenance therapy extended the median OS from 33.4 months to 55.9 months compared to placebo, with a hazard ratio (HR) of 0.73 and a p-value of 0.0104. The median PFS was also improved from 9.2 months to 16.6 months, with an HR of 0.76 and a p-value of 0.0161. The FDA approved Imfinzi on December 4, 2024, for adult patients with LS-SCLC who have not experienced disease progression after platinum-based CRT. The European Union approved the label change on March 12, 2025. DREAM is not a Phase 3 trial to re-establish this regulatory efficacy but rather a post-marketing study to generate real-world evidence in the Chinese setting, where concurrent and sequential CRT regimens are mixed, to broaden the reproducibility and applicability of the results.

Competitive and Commercial Significance

The current standard of care involves cisplatin or carboplatin combined with etoposide and concurrent thoracic radiation therapy. Imfinzi has established itself as an approved immune maintenance therapy administered after CRT. Roche Holding AG (RHHBY)'s Tecentriq (atezolizumab) targets the same PD-L1 pathway, but in the Phase 3 NRG-LU005 trial involving 554 patients, concurrent or adjuvant administration of CRT did not improve OS. The median OS was 39.5 months in the control group and 33.1 months in the Tecentriq group, with an HR of 1.11. This result supports the notion that the timing of immune checkpoint inhibitor administration is critical for efficacy and highlights the differentiation of Imfinzi's post-CRT maintenance strategy. Imfinzi's global product sales in 2025 reached $6.063 billion, a 29% increase year-over-year, further enhancing the commercial value of DREAM in supporting the expansion of Imfinzi prescriptions, reimbursement, and clinical guideline discussions in China.