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NSCLC Stage IVPhase 2NCT04549428

Atezolizumab Plus 8 Gy Single-fraction Radiotherapy for Advanced Oligoprogressive NSCLC

A Phase 2 study testing Atezolizumab in people with NSCLC Stage IV, run by Oncology Institute of Southern Switzerland at 3 sites in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Multicentre, phase II, open-label, single-arm study evaluating the preliminary efficacy, safety and tolerability of atezolizumab in association with palliative radiotherapy in adult patients diagnosed with advanced (stage IV) NSCLC, irrespective of PD-L1 status, and who have oligoprogressed to both immunotherapy with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC Stage IV
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
12 participants
Where
3 sitesSwitzerland
Study dates
1 Oct 2020to 31 May 2025
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Signed Informed Consent Form
  • Male or female aged ≥ 18 years
  • Ability to comply with the procedures of the study protocol, in the investigator's judgment
  • Histologically or cytologically confirmed diagnosis of metastatic (Stage IV) NSCLC as per the American Joint Committee on Cancer (AJCC) 8th edition
  • No sensitizing EGFR mutation (L858R or exon 19 deletions), ALK fusion oncogene or ROS1 rearrangement detected
  • Progressing to one line of chemotherapy defined as follows:a) A platinum-doublet.
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  • In case of patients being ineligible for platinum-containing regimens but otherwise compliant with the other inclusion-exclusion criteria of the present study, at least one line of mono-chemotherapy is required.
  • As an exception, patients with oligoprogression to anti PD-1 agents alone for whom the investigator considers local treatment of metastases and continuation of immunotherapy appropriate (i.e. would not be eligible for 2nd line treatment) may be enrolled without a previous line of chemotherapy. In this case, approval by the Project Leader is necessary.
  • Progressing to an anti-PD-1 agent, either associated to chemotherapy or as monotherapy (e.g., pembrolizumab or nivolumab)
  • Life expectancy ≥ 8 weeks
  • Patients with treated, asymptomatic central nervous system (CNS) metastases are eligible, provided they meet all of the following criteria:
  • Measurable disease outside CNS.
  • Only supratentorial and cerebellar metastases allowed (i.e., no metastases to midbrain, pons, medulla or spinal cord).
  • No ongoing requirement for corticosteroids as therapy for CNS disease; anticonvulsants at a stable dose allowed.
  • No stereotactic radiation within 7 days or whole-brain radiation within 14 days prior to initiating study treatment.
  • No evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study.
  • Patients with new asymptomatic CNS metastases detected at the screening scan must receive radiation therapy and/or surgery for CNS metastases. Following treatment, these patients may then be eligible without the need for an additional brain scan prior to initiating study treatment, if all other criteria are met, including clinical confirmation of no evidence of interim disease progression
  • Measurable disease by RECIST v1.1. Previously irradiated lesions can only be considered as measurable disease if disease progression has been unequivocally documented at that site since radiation and the previously irradiated lesion is not the only site of disease.
  • Oligoprogressive disease defined as follows:
  • A minimum of 1 and a maximum of 4 progressing lesions (with up to 3 total organs and 3 lesions per organ, except skeletal lesions) as assessed by a Positron Emission Tomography-Computed Tomography (PET-CT) scan (contrast enhanced).
  • Definition of progression is made by RECIST 1.1 criteria (new lesions or increased pre-existing ones).
  • Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to initiating study treatment:
  • Absolute neutrophil count ≥ 1,500 cells/μL without granulocyte colony-stimulating factor support b) White blood cell (WBC) counts > 2,500/μL c) Lymphocyte count > 500/μL d) Serum albumin > 2.5 g/dL e) Platelet count ≥ 100,000/μL without transfusion within 2 weeks of laboratory test used to determine eligibility f) Hemoglobin ≥ 9.0 g/dL, patients may be transfused or receive erythropoietic treatment to meet this criterion g) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALK) ≤ 2.5 × ULN with the following exceptions: patients with documented liver metastases: AST and/or ALT ≤ 5 × ULN; patients with documented liver or bone metastases: ALK ≤ 5 × ULN.
  • Serum bilirubin ≤ 1.5 × ULN. Patients with known Gilbert's syndrome who have serum bilirubin level ≤ 3 × ULN may be enrolled i) Serum creatinine ≤ 1.5 × ULN
  • For female patients of childbearing potential agreement to remain abstinent (refrain from heterosexual intercourse) or to use highly effective form(s) of contraceptive methods that result in a failure rate of < 1% per year when used consistently and correctly during the treatment period and for at least 5 months after the last dose of atezolizumab.
  • A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus)
  • Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, and established, proper use of hormonal contraceptives that inhibit ovulation (combined estrogen and progestogen containing hormonal contraception, or progestogen-only hormonal contraception associated with inhibition of ovulation together with another additional barrier method always containing a spermicide), hormone-releasing intrauterine devices, and copper intrauterine devices
  • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
  • Oral contraception should always be combined with an additional contraceptive method because of a potential interaction with the study drug.
  • Women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study drug.

Who cannot join

  • Cancer-specific exclusion criteria
  • Patients with an ECOG Performance status >2
  • Active or untreated CNS metastases as determined by Computed Tomography (CT) or magnetic resonance imaging (MRI) evaluation of the brain during screening and prior radiographic assessments
  • Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to initiating study treatment
  • Leptomeningeal disease.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters (e.g., PleurX®) are allowed.
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  • Uncontrolled hypercalcemia (>1.5 mmol/L ionized calcium or >3 mmol/L of corrected serum calcium) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab (patients who are receiving bisphosphonate therapy or denosumab specifically to prevent skeletal events and who do not have a history of clinically significant hypercalcemia are eligible; patients who are receiving denosumab to prevent or for mild hypercalcemia prior to enrollment must be willing and eligible to discontinue its use and replace it with a bisphosphonate instead while on study.)
  • History of other malignancy within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death (e.g. expected 5-year OS > 90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent, breast ductal carcinoma in situ treated surgically with curative intent).
  • NCI CTCAE Grade 3 or higher toxicities due to any prior therapy (e.g., radiotherapy) (excluding alopecia), which have not shown improvement and are strictly considered to interfere with current study medication, with special focus on prior toxicity to anti-PD1 agents.
  • General medical exclusion criteria
  • Women who are pregnant or lactating, or intending to become pregnant during the study. Women of childbearing potential including women who have had a tubal ligation, must have a negative serum pregnancy test result within 14 days prior to initiation of study drug.
  • History of autoimmune disease. Exceptions are:
  • Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone may be eligible for this study.
  • Patients with controlled Type I diabetes mellitus on a stable dose of insulin regimen are eligible for this study.
  • Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:
  • Rash must cover less than 10% of body surface area (BSA)
  • Disease is well controlled at baseline and only requiring low potency topical steroids
  • No acute exacerbations of underlying condition within the last 12 months requiring treatment with either psoralen plus ultraviolet radiation (PUVA), methotrexate, retinoids, biologic agents, oral calcineurin inhibitors or high potency or oral steroids
  • History of idiopathic pulmonary fibrosis (IPF), organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • Known positivity for human immunodeficiency virus (HIV)
  • Testing is not required in the absence of clinical symptoms and signs suggestive of HIV infection.
  • Patients with a past history of/or symptoms of HIV are eligible only if serological tests are negative.
  • Known active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or known active hepatitis C a) Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and hepatitis B surface antibody [HBsAb] and absence of HBsAg) are eligible. HBV DNA test must be performed if HBcAb is positive and HBsAb and HBsAg are negative, and in this case, a positive viremia excludes the patient from eligibility. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  • Severe infections within 4 weeks prior to initiating study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater), myocardial infarction within 3 months prior to initiating study treatment, unstable arrhythmias, or unstable angina.
  • Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction (LVEF) < 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate.
  • Major surgical procedure other than for diagnosis within 4 weeks prior to initiating study treatment or anticipation of need for a major surgical procedure during the course of the study
  • Prior allogeneic bone marrow transplantation or solid organ transplant
  • Any serious medical condition (including metabolic dysfunction, physical examination finding) or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study or that may affect the interpretation of the results or render the patient at high risk for treatment complications
  • Patients with an illness or condition that may interfere with capacity or compliance with the study protocol, as per investigator's judgment
  • Treatment with any other investigational agent or participation in another clinical study with therapeutic intent for the lung cancer within 28 days prior to initiating study treatment
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
  • Oral or IV antibiotic treatment. Patients will thus need to have recovered from any infection requiring antibiotics. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or to prevent chronic obstructive pulmonary disease exacerbation) are eligible.
  • Administration of a live, attenuated vaccine within 4 weeks before initiating study treatment or anticipation that such a live attenuated vaccine will be required during the study a) Influenza vaccination is allowed, but should be given during influenza season. However, patients must not receive live, attenuated influenza vaccine (e.g., FluMist®) within 4 weeks prior to initiating study treatment, at any time during the study or within 5 months after the last atezolizumab dose.
  • Prior treatment with CD137 agonists or anti-PD-L1 therapeutic antibodies. Patients who have had prior anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) treatment may be enrolled, provided the following requirements are met:
  • Minimum of 6 weeks from the last dose of anti-CTLA-4 b) No history of severe immune related adverse effects from anti-CTLA-4 (NCI CTCAE Grade 3 and 4)
  • Treatment with systemic corticosteroids or other immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents)
  • Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled in the study after discussion with and approval by the Medical Monitor.
  • The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed.
  • Patients with history of allergic reaction to IV contrast requiring steroid pre-treatment should have baseline and subsequent tumor assessments done by MRI.
  • Patients not willing to stop treatment with traditional herbal medicines
  • 1. Previously irradiated lesions having received the maximum permissible dose.

Trial locations and contacts

3 sites in 1 country.

Switzerland3 sites

  • Oncology Institute of Southern Switzerland

    Bellinzona, 6500

  • Cantonal Hospital of Graubünden (KSGR)

    Chur, 7000

  • Geneva University Hospitals (HUG)

    Geneva, 1205

Other trials in Switzerland

About this study

Official title: Atezolizumab Plus 8 Gy Single-fraction Radiotherapy for Advanced, Oligoprogressive NSCLC After Upfront Chemotherapy and Anti-PD1 Immunotherapy: A Multicentre, Single Arm, Phase II Study

Multicentre, phase II, open-label, single-arm study evaluating the preliminary efficacy, safety and tolerability of atezolizumab in association with palliative radiotherapy in adult patients diagnosed with advanced (stage IV) NSCLC, irrespective of PD-L1 status, and who have oligoprogressed to both immunotherapy with an anti PD-1 agent (e.g., pembrolizumab or nivolumab) and 1 line of chemotherapy.

Read the detailed description

Atezolizumab will be administered at a fixed dose of 1,200 mg by intravenous infusion every 21 days on an outpatient basis according to the its approved prescribing information. Palliative radiation therapy will be delivered concomitant to the 2nd dose of atezolizumab as a single fraction of 8 Gy to all eligible metastatic and primary sites.

Conditions
NSCLC Stage IV
Being tested
Atezolizumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • AtezolizumabDrug

    Also called Tecentriq

    Intravenous infusion every 21 days, until disease progression, intolerance or loss of clinical benefit.

Study groups in NCT04549428
Study groupRoleWhat they receive
AtezolizumabExperimentalAtezolizumab will be administered at a fixed dose of 1,200 mg by intravenous infusion every 21 days on an outpatient basis until progression, intolerance or loss of clinical benefit, according to the its approved prescribing information. Palliative radiation therapy will be delivered concomitant to the 2nd dose of atezolizumab as a single fraction of 8 Gy
Receives: Drug: Atezolizumab

What is being measured

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

  1. Objective Response Rate

    Percentage of patients with a complete response or partial response

    Measured: 3 months

Secondary outcomes (2)

  1. Overall Survival

    Time in months from the first day of study treatment to the date of death

    Measured: 12 months

  2. Progression Free-Survival

    Time in months from the first day of study treatment until the first evidence of tumour progression

    Measured: 12 months

Timeline

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

  1. First posted16 Sep 2020
  2. Study start1 Oct 2020
  3. Primary completion23 Jan 2023
  4. Study completion31 May 2025

Why it stopped: Terminated for futility, as determined by an interim data analysis.

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04549428
Sponsor's protocol ID
IOSI-LUNG-001
Status last verified
Nov 2025
First submitted
8 Sep 2020
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
No
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 NSCLC Stage IV, run by Oncology Institute of Southern Switzerland at 3 sites in Switzerland.

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 30 inclusion and 43 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: stopped early, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Switzerland. 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?

The study was stopped early (reason given: Terminated for futility, as determined by an interim data analysis.). Results are not available in the source record.

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?

Objective Response Rate (time frame: 3 months). 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 NCT04549428.

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 18 Nov 2025.

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