TROG 20.01 CHEST RT: Chemotherapy and Immunotherapy in Extensive Stage Small Cell Lung Cancer With Thoracic Radiotherapy

• Status: Recruiting
• Trial end date: 2026-07-31
• Target enrollment: 0
• Participant gender: All

Summary

Chemotherapy and Immunotherapy in extensive stage small cell lung cancer with thoracic radiotherapy

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trans Tasman Radiation Oncology Group
• Collaborator: AstraZeneca

Criteria

Inclusion Criteria:

• Age greater than or equal to 18,

• Untreated ES-SCLC patients

• Provided written informed consent

• Histologically or cytologically documented ES-SCLC - ES-SCLC defined as; American Joint Committee on Cancer [8th edition] SCLC stage IV

• T any, N any, M1 a/b/c, or

• T3?4 due to multiple lung nodules that are too extensive or have tumour/nodal volume that is too large to be encompassed in a feasible radiation plan

• ECOG performance-status score of 0 or 1 at registration. Patients with worse performance status (PS) prior to cycle 1 may be included if PS improves to 0-1 prior to cycle 2; these patients would be registered prior to cycle 2

• Life expectancy greater than or equal to 12 weeks at registration

• Brain metastases must be controlled or asymptomatic

• Thoracic disease deemed suitable for radiation therapy following initial systemic therapy

• Bodyweight of at least 30 kg

• Suitability for first-line platinum-based chemotherapy

• Adequate organ and marrow function; and negative pregnancy test for pre-menopausal women

• No prior exposure to immune-mediated therapy including, but not limited to, other anti-cytotoxic T-lymphocyte-associated antigen-4, anti-programmed cell death-1, anti-programmed cell death ligand-1, and anti-programmed cell death ligand-2 antibodies, excluding therapeutic anticancer vaccines.

Exclusion Criteria:

• Previous high dose radiotherapy to the chest precluding mediastinal radiation

• Significant active or previous autoimmune or inflammatory disorder

• Paraneoplastic syndrome of autoimmune nature requiring systemic treatment

• Interstitial lung disease/pulmonary fibrosis

• History of active primary immunodeficiency

• Uncontrolled, concurrent illness or active infections