NCT03540420

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.

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for phase_2

Timeline
11mo left

Started Jul 2018

Longer than P75 for phase_2

Geographic Reach
6 countries

41 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jul 2018Apr 2027

First Submitted

Initial submission to the registry

May 16, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 31, 2018

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Expected
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

5.7 years

First QC Date

May 16, 2018

Last Update Submit

April 9, 2026

Conditions

Small-cell Lung Cancer

Keywords

AtezolizumabChemoradiotherapyImmunotherapy

Outcome Measures

Primary Outcomes (1)

  • 2 year survival

    2 year after enrollment is completed

Secondary Outcomes (4)

  • Progression free survival

    2 year after enrollment is completed

  • Best response rate during study treatment period

    2 year after enrollment is completed

  • Number of treatment-related adverse events as assessed by CTCAE v5.0

    13 months after last patient completed atezolizumab therapy

  • Patient-reported Health related quality of life on the EORTC QLQ-C30 and LC13 questionnaires.

    2 year after enrollment is completed

Study Arms (2)

Atezolizumab

EXPERIMENTAL

atezolizumab after completed chemo-radiotherapy and non-progression

Drug: Atezolizumab

Observation

NO INTERVENTION

standard care after completed chemo-radiotherapy and non-progression

Interventions

AtezolizumabDRUG

atezolizumab 1200 mg intravenous every 3 weeks in 12 months

Also known as: anti-PDL1, Tecentriq
Atezolizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (41)

Aalborg Universitetshospital

Aalborg, Denmark

Location

Rigshospitalet

Copenhagen, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

National Cancer Institute

Vilnius, Lithuania

Location

Antoni van Leeuwenhoek Ziekenhuis

Amsterdam, Netherlands

Location

Rijnstate Ziekenhuis

Arnhem, Netherlands

Location

Amphia Ziekenhuis

Breda, Netherlands

Location

Medische Centrum Twente

Enschede, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

Zuyderland Ziekenhuis

Sittard, Netherlands

Location

Antonius Ziekenhuis

Utrecht, Netherlands

Location

Isala Ziekenhuis

Zwolle, Netherlands

Location

Ålesund Hospital

Ålesund, Norway

Location

Haukeland Universitetssykehus

Bergen, Norway

Location

Drammen sykehus - Vestre Viken

Drammen, Norway

Location

Haugesund hospital

Haugesund, Norway

Location

Sørlandet Sykehus

Kristiansand, Norway

Location

Sykehuset i Kristansund

Kristiansund, Norway

Location

Sykehuset Levanger

Levanger, Norway

Location

Molde Sjukehus

Molde, Norway

Location

Akershus Universitetssykehus AHUS

Oslo, Norway

Location

Oslo University Hospital Ullevål

Oslo, Norway

Location

Stavanger University Hospital

Stavanger, Norway

Location

Universitetssykehuset Nord-Norge

Tromsø, Norway

Location

Cancer Clinic at St. Olavs Hospital

Trondheim, Norway

Location

Volda hospital

Volda, Norway

Location

Gävle hospital

Gävle, Sweden

Location

Sahlgrenska Universitetssjukhus

Gothenburg, Sweden

Location

Universitetssjukhuset Linköping

Linköping, Sweden

Location

Skånes University Hospital

Lund, Sweden

Location

Universitetssjukhuset Örebro

Örebro, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Universitätsspital Basel

Basel, Switzerland

Location

Inselspital

Bern, Switzerland

Location

University Hospital Inselspital

Bern, Switzerland

Location

Kantonsspital Graubünden

Chur, Switzerland

Location

Kantonsspital Olten - Solothurner Spitäler

Olten, Switzerland

Location

Cantonal Hospital of St. Gallen

Sankt Gallen, Switzerland

Location

Spital STS AG

Thun, Switzerland

Location

Kantonsspital Winterthur

Winterthur, Switzerland

Location

Hirslanden Klinik

Zurich, Switzerland

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Torstein B Rø, MD, PhD

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2018

First Posted

May 30, 2018

Study Start

July 31, 2018

Primary Completion

April 1, 2024

Study Completion (Estimated)

April 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

NO(14)DK(3)SE(6)LI(1)CH(9)NL(8)