A randomized phase II study comparing atezolizumab after concurrent chemo-radiotherapy with chemo-radiotherapy alone in limited disease small-cell lung cancer (ACHILES study)

Phase 2

Recruiting

• Conditions: cancer; small-cell longcancer; 10029107

• Registration Number: NL-OMON49619
• Lead Sponsor: orwegian University of Science and Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1. Age >= 18 years.
2. Histologically or cytologically confirmed SCLC
3. Previous radiotherapy to the thorax is allowed as long as the patient can
receive TRT of 45-60 Gy.
4. Stage I-III according to TNM v8, ineligible for surgery provided all lesions
can be included in a tolerable radiotherapy field (*limited disease*).
5. ECOG performance status 0-2.
6. Measureable disease.
7. Adequate organ function. See protocol chapter 5 for details.
8. FEV1 > 1 L or > 30 % of predicted value and DLCO > 30 % of predicted value.
9. Female patients of childbearing potential should use highly effective
contraception. See protocol chapter 5 for details.

Exclusion Criteria

1. Prior systemic therapy for SCLC or immune checkpoint blockade therapy.
2. Malignant cells in pericardial or pleural fluid. See protocol chapter 5 for
details.
3. Serious concomitant systemic disorders. See protocol chapter 5 for details.
4. Lung disease requiring systemic steroids in doses of >10 mg prednisolone (or
equivalent dose of other steroid).
5. Previous allogeneic or organ transplant.
6. Active or history of autoimmune disease or immune deficiency. See protocol
chapter 5 for details.
7. History of certain lung diseases. See protocol chapter 5 for details.
8. Live vaccine administered last 30 days, active infection requiring IV
antibiotics, active viral hepatitis or HIV.
9. Pregnancy or lactation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>OS</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>BRR, PFS, adverse events, quality of life.</p><br>