ACHILES Does immunotherapy improve the survival of patients with small cell lung cancer in the Limited Disease stage who have received chemotherapy and radiation therapy?

Denmark, Lithuania, Netherlands, Norway, Sweden, Switzerland (ICTRP)

ID di studio ICTRP
NCT03540420 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
ACHILES A randomized phase II study comparing atezolizumab after concurrent chemoradiotherapy with chemoradiotherapy alone in limited disease small-cell lung cancer (BASEC)

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

Titolo pubblico
Atezolizumab After Concurrent Chemo-radiotherapy Versus Chemo-radiotherapy Alone in Limited Disease Small-cell Lung Cancer (ICTRP)

Malattie studiate
Small-cell Lung Cancer (ICTRP)

Intervento studiato
Drug: Atezolizumab (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Criteri di inclusione/esclusione
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:

- Histologically or cytologically confirmed small-cell lung cancer

- Previous radiotherapy to the thorax is allowed as long as the patient can receive
TRT of 45 Gy.

- Stage I-III according to TNM v8 ineligible for surgery provided all lesions can be
included in a tolerable radiotherapy field ("limited disease")

- ECOG performance status 0-2

- Measureable disease according to the RECIST 1.1

- Adequate organ function defined as: (a) Serum alanine transaminase (ALT) = 2.5 x
upper limit of normal (ULN); (b) Total serum bilirubin = 1.5 x ULN; (c)Absolute
neutrophil count (ANC) = 1.5 x 10 superscr 9/L; (d) Platelets = 100 x 10 superscr
9/L ; (e) Creatinine < 100 ?mol/L and calculated creatinine-clearance > 50 ml/min.
If calculated creatinine-clearance is < 50 ml/min, an EDTA clearance should be
performed

- No malignant cells in pericardial or pleural fluid (at least 1 sample should be
obtained if pleural fluid is present) If there is so little fluid that it cannot
easily be collected, the patient is considered eligible.

- Pulmonary function: FEV1 > 1 l or > 30 % of predicted value and DLCO > 30 % of
predicted value

- Female patients of childbearing potential (Postmenarcheal, not postmenopausal (>12
continuous months of amenorrhea with no identified cause other than menopause), and
no surgical sterilization) should use highly effective contraception and take active
measures to avoid pregnancy while undergoing atezolizumab treatment and for at least
5 months after the last dose. Birth control methods considered to be highly
effective are listed in Appendix D of the protocol

- Written informed consent

Exclusion Criteria:

- previous systemic therapy for SCLC or immune checkpoint blockade therapy

- serious concomitant systemic disorders (for example active infection, unstable
cardiovascular disease) which in the opinion of the investigator would compromise
the patient's ability to complete the study, or would interfere with the evaluation
of the efficacy and safety of the study treatment

- lung disease requiring systemic steroids in doses of >10 mg prednisolone (or
equivalent dose of other steroid)

- previous allogeneic or organ transplant

- active or history of autoimmune disease or immune deficiency, including, but not
limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus
erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid
antibody syndrome, Wegener granulomatosis, Sj?gren syndrome, Guillain-Barr?
syndrome, or multiple sclerosis

- history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis
obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of
active pneumonitis on screening chest computed tomography (CT) scan

- live vaccine administered in the last 30 days

- active infection requiring IV antibiotics

- active viral hepatitis or HIV-positive

- conditions - medical, social, psychological - which could prevent adequate
information and follow-up

- clinically active cancer other than SCLC with the exception of malignancies with a
negligible risk of metastases or death (e.g. 5-years OS rate of >90%), such as
adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma,
localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer.
Hormonal therapy for non-metastatic prostate or breast cancer is allowed.

- pregnant or lactating women (ICTRP)

non disponibile

Endpoint primari e secondari
2 year survival (ICTRP)

Progression free survival;Best response rate during study treatment period;Number of treatment-related adverse events as assessed by CTCAE v5.0;Patient-reported Health related quality of life on the EORTC QLQ-C30 and LC13 questionnaires. (ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
University Hospital of North Norway;Alesund Hospital;Vestre Viken Hospital Trust;University Hospital, Akershus;Helse Nord-Tr?ndelag HF;Helse Stavanger HF;Haukeland University Hospital;Sorlandet Hospital HF;Ullevaal University Hospital;Molde Hospital;Helse Fonna;Nordlandssykehuset HF;Volda Hospital;Kristiansund Hospital;Sahlgrenska University Hospital, Sweden;Skane University Hospital;Karolinska University Hospital;?rebro University Hospital;G?vle Hospital;University Hospital, Linkoeping;Odense University Hospital;Aalborg University Hospital;Rigshospitalet, Denmark;National Cancer Institute, Lithuania;Kantonsspital Winterthur KSW;University Hospital, Basel, Switzerland;Insel Gruppe AG, University Hospital Bern;Kantonsspital Graub?nden;Freiburger Spital;Klinik Hirslanden, Zurich;Kantonsspital Olten;Spital STS AG;Ente Ospedaliero Cantonale, Bellinzona;Cantonal Hospital of St. Gallen;St. Olavs Hospital;Oslo University Hospital;Rijnstate Hospital;Isala;Zuyderland Medisch Centrum;The Netherlands Cancer Institute;St. Antonius Hospital;Amphia Hospital;Medisch Spectrum Twente;Erasmus Medical Center (ICTRP)

Contatti aggiuntivi
Torstein B R?, MD, PhD, Norwegian University of Science and Technology (ICTRP)

ID secondari
2017-004572-62, 2017-11-03BHG (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT03540420 (ICTRP)