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Immunotherapy after Chemo-Radiation may boost lung cancer survival

NCT ID NCT03540420

Disease control Sponsor: Norwegian University of Science and Technology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding the immunotherapy drug atezolizumab after standard chemo-radiotherapy helps people with limited-stage small-cell lung cancer live longer. About 212 participants will receive either atezolizumab or no additional treatment after chemo-radiation. The goal is to see if the drug improves 2-year survival rates.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

212 people

The number who actually took part.

Started

Jul 2018

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Small cell lung cancer

Contacts and locations

Locations

  • Aalborg Universitetshospital

    Aalborg, Denmark

  • Akershus Universitetssykehus AHUS

    Oslo, Norway

  • Amphia Ziekenhuis

    Breda, Netherlands

  • Antoni van Leeuwenhoek Ziekenhuis

    Amsterdam, Netherlands

  • Antonius Ziekenhuis

    Utrecht, Netherlands

  • Cancer Clinic at St. Olavs Hospital

    Trondheim, Norway

  • Cantonal Hospital of St. Gallen

    Sankt Gallen, Switzerland

  • Drammen sykehus - Vestre Viken

    Drammen, Norway

  • Erasmus MC

    Rotterdam, Netherlands

  • Gävle hospital

    Gävle, Sweden

  • Haugesund hospital

    Haugesund, Norway

  • Haukeland Universitetssykehus

    Bergen, Norway

  • Hirslanden Klinik

    Zurich, Switzerland

  • Inselspital

    Bern, Switzerland

  • Isala Ziekenhuis

    Zwolle, Netherlands

  • Kantonsspital Graubünden

    Chur, Switzerland

  • Kantonsspital Olten - Solothurner Spitäler

    Olten, Switzerland

  • Kantonsspital Winterthur

    Winterthur, Switzerland

  • Karolinska University Hospital

    Stockholm, Sweden

  • Medische Centrum Twente

    Enschede, Netherlands

  • Molde Sjukehus

    Molde, Norway

  • National Cancer Institute

    Vilnius, Lithuania

  • Odense University Hospital

    Odense, Denmark

  • Oslo University Hospital Ullevål

    Oslo, Norway

  • Rigshospitalet

    Copenhagen, Denmark

  • Rijnstate Ziekenhuis

    Arnhem, Netherlands

  • Sahlgrenska Universitetssjukhus

    Gothenburg, Sweden

  • Skånes University Hospital

    Lund, Sweden

  • Spital STS AG

    Thun, Switzerland

  • Stavanger University Hospital

    Stavanger, Norway

  • Sykehuset Levanger

    Levanger, Norway

  • Sykehuset i Kristansund

    Kristiansund, Norway

  • Sørlandet Sykehus

    Kristiansand, Norway

  • Universitetssjukhuset Linköping

    Linköping, Sweden

  • Universitetssjukhuset Örebro

    Örebro, Sweden

  • Universitetssykehuset Nord-Norge

    Tromsø, Norway

  • University Hospital Inselspital

    Bern, Switzerland

  • Universitätsspital Basel

    Basel, Switzerland

  • Volda hospital

    Volda, Norway

  • Zuyderland Ziekenhuis

    Sittard, Netherlands

  • Ålesund Hospital

    Ålesund, Norway

More trials for these conditions

Other studies related to the condition(s) this trial covers.