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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49619

Enrollment

100

Registered

2019-10-03

Start date

2020-06-09

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

cancer small-cell longcancer

Interventions

Treatment with chemo-radiotherapy with or without adjuvant follow-up treatment with atezolizumab.

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
OS	—

Secondary

Measure	Time frame
BRR, PFS, adverse events, quality of life.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)