A Phase II randomized Study to evaluate the efficacy and safety of Cisplatin or Carboplatin / Etoposide and concomitant Radiotherapy combined with Durvalumab followed by Maintenance Therapy with Durvalumab versus Cisplatin or Carboplatin / Etoposide and concomitant Radiotherapy in Patients with limited disease Small Cell Lung Cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513433-20-00

Enrollment

105

Registered

2024-09-03

Start date

2020-12-16

Completion date

Unknown

Last updated

2025-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Limited Disease Small Cell Lung Cancer

Brief summary

Progression-free survival (PFS) after 18 months according to RECIST1.1 as well as iRECIST for Durvalumab group only

Detailed description

Progression-free survival (PSF) after other assessments, Overall survival (OS), Overall response rate (ORR), Disease control rate (DCR), Safety and Tolerability, Symptom control assessed by patient-reported quality of life (QoL) with QLQ-C30, QLQ-LC13 and EQ-5D

Interventions

DRUGETOPOSIDE

DRUGCARBOPLATIN

DRUGCISPLATIN

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS) after 18 months according to RECIST1.1 as well as iRECIST for Durvalumab group only	—

Secondary

Measure	Time frame
Progression-free survival (PSF) after other assessments, Overall survival (OS), Overall response rate (ORR), Disease control rate (DCR), Safety and Tolerability, Symptom control assessed by patient-reported quality of life (QoL) with QLQ-C30, QLQ-LC13 and EQ-5D	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026