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Imfinzi NSCLC
Imfinzi NSCLC
JOURNAL ONKOLOGIE – STUDIE
ACHILES

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

Rekrutierend

NCT-Nummer:
NCT03540420

Studienbeginn:
Juli 2018

Letztes Update:
14.12.2020

Wirkstoff:
Atezolizumab

Indikation (Clinical Trials):
Lung Neoplasms, Small Cell Lung Carcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Norwegian University of Science and Technology

Collaborator:
University Hospital of North Norway, Alesund Hospital, Vestre Viken Hospital Trust, University Hospital, Akershus, Levanger Hospital, Helse Stavanger HF, Haukeland University Hospital, Sorlandet Hospital HF, Ullevaal University Hospital, Molde Hospital, Helse Fonna

Studienleiter

Torstein B Rø, MD, PhD
Study Director
Norwegian University of Science and Technology

Kontakt

Studienlocations
(3 von 41)

Alle anzeigen

Studien-Informationen

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).

Ein-/Ausschlusskriterien

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 µmol/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, Sjögren syndrome, Guillain-Barré 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

Studien-Rationale

Primary outcome:

1. 2 year survival (Time Frame - 2 year after enrollment is completed)



Secondary outcome:

1. Progression free survival (Time Frame - 2 year after enrollment is completed)

2. Best response rate during study treatment period (Time Frame - 2 year after enrollment is completed)

3. Number of treatment-related adverse events as assessed by CTCAE v5.0 (Time Frame - 13 months after last patient completed atezolizumab therapy):
The number of mild (grade 1-2), severe (grade 3-4) and fatal (grade 5) events during the chemoradiotherapy will be reported for the whole study cohort.

4. Patient-reported Health related quality of life on the EORTC QLQ-C30 and LC13 questionnaires. (Time Frame - 2 year after enrollment is completed):
Patients will report HRQoL before and after chemoradiotherapy and then at each evaluation the first 2 years. Mean scores will be compared at each timepoint. A difference of 10 points or more is considered clinically relevant.

Studien-Arme

  • Experimental: Atezolizumab
    atezolizumab after completed chemo-radiotherapy and non-progression
  • No Intervention: Observation
    standard care after completed chemo-radiotherapy and non-progression

Geprüfte Regime

  • Atezolizumab (anti-PDL1 / Tecentriq / ):
    atezolizumab 1200 mg intravenous every 3 weeks in 12 months

Quelle: ClinicalTrials.gov


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