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Small-cell Lung CancerPhase 2ACHILESNCT03540420

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

A Phase 2 study testing Atezolizumab in people with Small-cell Lung Cancer, run by Norwegian University of Science and Technology at 41 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small-cell Lung Cancer
What is being tested?
Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
212 participants
Where
41 sitesin 6 countries
Study dates
31 Jul 2018to 1 Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

41 sites in 6 countries.

41 sites in 6 countries

Norway14 sites

  • Ålesund Hospital

    Ålesund

  • Haukeland Universitetssykehus

    Bergen

  • Drammen sykehus - Vestre Viken

    Drammen

  • Haugesund hospital

    Haugesund

  • Sørlandet Sykehus

    Kristiansand

  • Sykehuset i Kristansund

    Kristiansund

  • Sykehuset Levanger

    Levanger

  • Molde Sjukehus

    Molde

  • Akershus Universitetssykehus AHUS

    Oslo

  • Oslo University Hospital Ullevål

    Oslo

  • Stavanger University Hospital

    Stavanger

  • Universitetssykehuset Nord-Norge

    Tromsø

  • Cancer Clinic at St. Olavs Hospital

    Trondheim

  • Volda hospital

    Volda

Other trials in Norway

Switzerland9 sites

  • Universitätsspital Basel

    Basel

  • Inselspital

    Bern

  • University Hospital Inselspital

    Bern

  • Kantonsspital Graubünden

    Chur

  • Kantonsspital Olten - Solothurner Spitäler

    Olten

  • Cantonal Hospital of St. Gallen

    Sankt Gallen

  • Spital STS AG

    Thun

  • Kantonsspital Winterthur

    Winterthur

  • Hirslanden Klinik

    Zurich

Other trials in Switzerland

Netherlands8 sites

  • Antoni van Leeuwenhoek Ziekenhuis

    Amsterdam

  • Rijnstate Ziekenhuis

    Arnhem

  • Amphia Ziekenhuis

    Breda

  • Medische Centrum Twente

    Enschede

  • Erasmus MC

    Rotterdam

  • Zuyderland Ziekenhuis

    Sittard

  • Antonius Ziekenhuis

    Utrecht

  • Isala Ziekenhuis

    Zwolle

Other trials in Netherlands

Sweden6 sites

  • Gävle hospital

    Gävle

  • Sahlgrenska Universitetssjukhus

    Gothenburg

  • Universitetssjukhuset Linköping

    Linköping

  • Skånes University Hospital

    Lund

  • Universitetssjukhuset Örebro

    Örebro

  • Karolinska University Hospital

    Stockholm

Other trials in Sweden

Denmark3 sites

  • Aalborg Universitetshospital

    Aalborg

  • Rigshospitalet

    Copenhagen

  • Odense University Hospital

    Odense

Other trials in Denmark

Lithuania1 site

  • National Cancer Institute

    Vilnius

Other trials in Lithuania

About this study

Official title: A Randomized Phase II Study Comparing Atezolizumab After Concurrent Chemo-radiotherapy With Chemo-radiotherapy Alone in Limited Disease Small-cell Lung Cancer

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.

Read the 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).
Being tested
Atezolizumab
Keywords
Atezolizumab, Chemoradiotherapy, Immunotherapy
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called anti-PDL1, Tecentriq

    atezolizumab 1200 mg intravenous every 3 weeks in 12 months

Study groups in NCT03540420
Study groupRoleWhat they receive
AtezolizumabExperimentalatezolizumab after completed chemo-radiotherapy and non-progression
Receives: Drug: Atezolizumab
ObservationNo interventionstandard care after completed chemo-radiotherapy and non-progression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2 year survival

    Measured: 2 year after enrollment is completed

Secondary outcomes (4)

  1. Progression free survival

    Measured: 2 year after enrollment is completed

  2. Best response rate during study treatment period

    Measured: 2 year after enrollment is completed

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

    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.

    Measured: 13 months after last patient completed atezolizumab therapy

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

    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.

    Measured: 2 year after enrollment is completed

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2018
  2. Study start31 Jul 2018
  3. Primary completion1 Apr 2024
  4. Study completion1 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
212 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03540420
Sponsor's protocol ID
2017-11-03BHG
Other IDs
2017-004572-62, 2017
Acronym
ACHILES
Status last verified
Apr 2026
First submitted
16 May 2018
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab in people with Small-cell Lung Cancer, run by Norwegian University of Science and Technology at 41 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in Norway, Switzerland, Netherlands, Sweden, Denmark and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2 year survival (time frame: 2 year after enrollment is completed). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03540420.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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