A randomized phase II study comparing atezolizumab after concurrent chemoradiotherapy with chemoradiotherapy alone in limited disease small-cell lung cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Norwegian University Of Science And Technolology

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

31 Jul 2018 → ongoing

Decision date (initial)

2024-10-11

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-515755-37-00

EudraCT number

2017-004572-62

ClinicalTrials.gov

NCT03540420

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

To investigate whether atezolizumab improves survival in patients with LD SCLC who have completed chemoradiotherapy (overall survival).

Conditions and MedDRA coding

Limited disease small-cell lung cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Age ≥ 18 years
2. Written informed consent
3. Histologically or cytologically confirmed small-cell lung cancer
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. Measurable disease according to the RECIST 1.1. if the patient is enrolled before chemoradiotherapy commences.
7. Adequate kidney, liver and bone marrow function.
8. Pulmonary function: FEV1 >1 L or >30 % of predicted value and DLCO >30 % of predicted value. If there are reasons to believe that the lung function is reduced due to tumour obstruction of the lung or central airways, the patient is still eligible as long as a radiotherapist consider the patient eligible for thoracic radiotherapy.

Exclusion criteria 9

1. Malignant cells in pericardial or pleural fluid
2. Serious concomitant systemic disorders including disease requiring systemic steroids in doses of >10 mg prednisolone (or equivalent dose of other steroid), previous allogeneic or organ transplant, autoimmune disease or immune deficiency, idiopathic pulmonary fibrosis, or pneumonitis
3. Live vaccine last 30 days, active infection requiring IV antibiotics, no active viral hepatitis or HIV
4. Clinically active cancer other than SCLC with the exception of malignancies with a negligible risk of metastases or death (i.e. 5-years OS rate of >90%)
5. History of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins as well as known hypersensitivity to CHO cell products or any component of atezolizumab
6. Lung disease requiring systemic steroids in doses of >10 mg prednisolone (or equivalent dose of other steroid)
7. Previous allogeneic or organ transplant
8. 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
9. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Overall survival

Secondary endpoints 4

1. Best response rates (best response observed through the whole study period)
2. Progression free survival
3. Toxicity
4. Health related quality of life

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Norwegian University Of Science And Technolology

Sponsor organisation

Norwegian University Of Science And Technolology

Address

Hoegskoleringen 1

City

Trondheim

Postcode

7034

Country

Norway

Scientific contact point

Organisation

Norwegian University Of Science And Technolology

Contact name

Bjørn Henning Grønberg

Public contact point

Organisation

Norwegian University Of Science And Technolology

Contact name

Bjørn Henning Grønberg

Third parties 5

Locations

5 EU/EEA countries · 25 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications