NCT03540420

Atezolizumab After Concurrent Chemo-radiotherapy Versus Chemo-radiotherapy Alone in Limited Disease Small-cell Lung Cancer

A Randomized Phase II Study Comparing Atezolizumab After Concurrent Chemo-radiotherapy With Chemo-radiotherapy Alone in Limited Disease Small-cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 212 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Some patients with limited disease small-cell lung cancer (LD SCLC) are cured after chemo-radiotherapy, but the majority relapse and die from their cancer. Better therapy is needed. Immunotherapy represents the largest advance in cancer therapy in recent years and has demonstrated promising activity in SCLC. In this study we will investigate whether atezolizumab prolongs survival in LD SCLC patients who have undergone chemo-radiotherapy.

Detailed description

Patients who have * completed 4 course of platinum/etoposide and thoracic radiotherapy of 45 Gy/30 fractions, 2 fractions per day * non-progression after chemo-radiotherapy * ECOG performance status 0-2 will be randomized to receive atezolizumab 1200 mg IV every 3 weeks in 12 months or standard of care (observation).

Conditions

• Small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Atezolizumab	atezolizumab 1200 mg intravenous every 3 weeks in 12 months

Timeline

• Start date: 2018-07-31
• Primary completion: 2024-04-01
• Completion: 2027-04-01
• First posted: 2018-05-30
• Last updated: 2026-04-13

Locations

41 sites across 6 countries: Denmark, Lithuania, Netherlands, Norway, Sweden, Switzerland