A Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non-Small Cell Lung Cancer
Summary
This is a Phase II, randomized, multi-center, multinational, open-label, cross-over study in adult participants with PD-L1-positive NSCLC. Two populations will be included: participants with resected Stage II, IIIA, and selected IIIB (T3-N2) NSCLC who have completed adjuvant platinum-based chemotherapy without evidence of disease relapse/recurrence, and chemotherapy-naïve participants with Stage IV NSCLC. The study will evaluate participant- and healthcare professionals (HCP)-reported preference for atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV).
Timeline
- Start
- 2022-04-04
- Primary completion
- 2023-11-09
- Completion
- 2024-10-25
Outcome
Met primary endpoint
paper The primary analysis of IMscin002 (NCT05171777) demonstrated that most patients preferred atezolizumab subcutaneous (SC) administration over intravenous (IV) administration; PMID 41296193 ↗
paper Overall, 87/123 patients (70.7%) preferred atezolizumab SC PMID 41296193 ↗
Publications
- Burotto M, Zvirbule Z, Alvarez R, Chewaskulyong B, Felip E, Majem M, Korbenfeld E, Kolb-Sielecki J, Isla D, Barata T, Bustillos A, Herraez-Baranda LA, Tosti N, Young F, Zanghi J, Cappuzzo F. Efficacy and safety of subcutaneous and intravenous administration of atezolizumab in patients with non-small cell lung cancer, including early-stage, locally advanced or metastatic disease: Updated results of the IMscin001 and IMscin002 randomized studies. Lung Cancer. 2026 Jul;217:109452. doi: 10.1016/j.lungcan.2026.109452. Epub 2026 May 12.
- Majem M, Chewaskulyong B, Zvirbule Z, Lee KH, Korbenfeld E, Kolb-Sielecki J, Castro Sanchez AY, Bustillos A, Herraez-Baranda L, Liu X, Kim SW, Cappuzzo F. Exploratory Analyses of Patient Preferences for Atezolizumab Subcutaneous Versus Intravenous from the IMscin002 Study in Patients with Non-Small Cell Lung Cancer. Oncol Ther. 2026 Mar;14(1):313-326. doi: 10.1007/s40487-025-00402-x. Epub 2025 Nov 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 1200 mg | Subcutaneous |
| Subject | Atezolizumab | Monoclonal antibody | 1875 mg | Subcutaneous |