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

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ClinicalTrials.gov Identifier: NCT03540420
Recruitment Status : Recruiting
First Posted : May 30, 2018
Last Update Posted : June 12, 2019
Sponsor:
Collaborators:
University Hospital of North Norway
Alesund Hospital
Vestre Viken Hospital Trust
University Hospital, Akershus
Levanger Hospital
Helse Stavanger HF
The Hospital of Vestfold
Haukeland University Hospital
Sorlandet Hospital HF
Ullevaal University Hospital
Molde Hospital
Helse Fonna
Nordlandssykehuset HF
Førde Central Hospital
Ostfold Hospital Trust
Namsos Hospital
Volda Hospital
Sykehuset Innlandet HF
Kristiansund Hospital
Sahlgrenska University Hospital, Sweden
Skane University Hospital
Karolinska University Hospital
Ôrebro University Hospital
Gävle Hospital
Norrlands University Hospital
University Hospital, Linkoeping
Odense University Hospital
Herlev Hospital
Aalborg University Hospital
Aarhus University Hospital
Vejle Hospital
Rigshospitalet, Denmark
National Cancer Institute, Lithuania
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief Summary:
Some patients with limited disease small-cell lung cancer (LD SCLC) are cured after chemo-radiotherapy, but the majority relapse and die from their cancer. Better therapy is needed. Immunotherapy represents the largest advance in cancer therapy in recent years and has demonstrated promising activity in SCLC. In this study we will investigate whether atezolizumab prolongs survival in LD SCLC patients who have undergone chemo-radiotherapy.

Condition or disease Intervention/treatment Phase
Small-cell Lung Cancer Drug: Atezolizumab Phase 2

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study Comparing Atezolizumab After Concurrent Chemo-radiotherapy With Chemo-radiotherapy Alone in Limited Disease Small-cell Lung Cancer
Actual Study Start Date : July 31, 2018
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Atezolizumab
atezolizumab after completed chemo-radiotherapy and non-progression
Drug: Atezolizumab
atezolizumab 1200 mg intravenous every 3 weeks in 12 months
Other Names:
  • anti-PDL1
  • Tecentriq

No Intervention: Observation
standard care after completed chemo-radiotherapy and non-progression



Primary Outcome Measures :
  1. 2 year survival [ Time Frame: 2 year after enrollment is completed ]

Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03540420


Contacts
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Contact: Bjørn H Grønberg, MD, PhD +47 47297878 bjorn.h.gronberg@ntnu.no

Locations
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Denmark
Herlev Hospital Not yet recruiting
Herlev, Denmark
Contact: Jon Lykkegaard Andersen         
Odense University Hospital Recruiting
Odense, Denmark
Contact: Tine Schytte         
Norway
Drammen sykehus - Vestre Viken Recruiting
Drammen, Norway
Contact: Inger Storaker         
Molde Sjukehus Recruiting
Molde, Norway
Contact: Inger Storaker         
Oslo University Hospital Ullevål Recruiting
Oslo, Norway
Contact: Maria Moksnes Bjaanes         
Cancer Clinic at St. Olavs Hospital Recruiting
Trondheim, Norway
Contact: Bjørn Henning Grønberg, md prof       inger.storaker@ntnu.no   
Ålesund Hospital Recruiting
Ålesund, Norway
Contact: Øyvind Yksnøy         
Sweden
Sahlgrenska Universitetssjukhus Recruiting
Göteborg, Sweden
Contact: Inger Storaker         
Skånes University Hospital Recruiting
Lund, Sweden
Contact: Maria Planck         
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Georgios Tsakonas         
Sponsors and Collaborators
Norwegian University of Science and Technology
University Hospital of North Norway
Alesund Hospital
Vestre Viken Hospital Trust
University Hospital, Akershus
Levanger Hospital
Helse Stavanger HF
The Hospital of Vestfold
Haukeland University Hospital
Sorlandet Hospital HF
Ullevaal University Hospital
Molde Hospital
Helse Fonna
Nordlandssykehuset HF
Førde Central Hospital
Ostfold Hospital Trust
Namsos Hospital
Volda Hospital
Sykehuset Innlandet HF
Kristiansund Hospital
Sahlgrenska University Hospital, Sweden
Skane University Hospital
Karolinska University Hospital
Ôrebro University Hospital
Gävle Hospital
Norrlands University Hospital
University Hospital, Linkoeping
Odense University Hospital
Herlev Hospital
Aalborg University Hospital
Aarhus University Hospital
Vejle Hospital
Rigshospitalet, Denmark
National Cancer Institute, Lithuania
Investigators
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Study Director: Thorstein B Rø, MD, PhD Norwegian University of Science and Technology

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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03540420     History of Changes
Other Study ID Numbers: 2017-11-03BHG
2017-004572-62 ( EudraCT Number )
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Norwegian University of Science and Technology:
Atezolizumab
Chemoradiotherapy
Immunotherapy

Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Atezolizumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs