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Small Cell Lung Cancer Extensive StagePhase 2TREASURENCT04462276

Thoracic RadiothErapy With Atezolizumab in Small Cell lUng canceR Extensive Disease

A Phase 2 study testing Atezolizumab and thoracic radiotherapy (TRT) in people with Small Cell Lung Cancer Extensive Stage and Thoracic Radiotherapy, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 20 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a multicenter phase 2 clinical trial to investigate the treatment efficacy and feasibility of combining thoracic radiotherapy (TRT) with the IMpower133 regimen in the upfront treatment of ED SCLC patients. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Atezolizumab and thoracic radiotherapy (TRT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
20 sitesin 2 countries
Study dates
28 Jul 2020to 2 Sep 2024
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

  • Fully-informed written consent and locally required authorization (European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
  • Age ≥ 18 years.
  • Histologically or cytologically confirmed ED SCLC as defined according to the Veterans Administration Lung Study Group staging system.
  • Measurable ED SCLC according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. In cases of CR or PR without residual measurable disease after 4 cycles of induction therapy, patients may still be included. In such cases "No Evidence of Disease (NED)" should be reported in eCRF.
  • ECOG performance status score of 0 or 1 at screening
  • Any response after four cycles of standard chemo-immunotherapy (carboplatin, etoposide, atezolizumab) defined as CR/PR or thoracic SD with CR/PR of extrathoracic lesions as per RECIST 1.1
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  • Thoracic treatment volume considered treatable using acceptable radiation fields as judged by a radiation oncologist
  • 28 ± 7 days between last administration of chemo-immunotherapy (carboplatin, etoposide, atezolizumab) and randomization.
  • Patients with a history of treated CNS metastases are eligible, if there is no ongoing requirement for corticosteroids as therapy for CNS disease. Before randomization, MRI of brain (with contrast, unless contraindicated) is recommended in subjects with suspected or known brain metastases, as per local standard., Patients with asymptomatic brain metastases that do not require local therapy with irradiation (whole brain irradiation) can be included. In ambiguous cases, consultation with the LKP or his/her delegate is advised.
  • No previous radiotherapy to lung and mediastinal lymph nodes within the past 5 years before the first dose of study drug.
  • Availability of pre-treatment tumor tissue specimen
  • The patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations.
  • FEV1 ≥ 40% (%Soll)
  • Adequate bone marrow and renal function including the following:
  • Hemoglobin ≥ 9.0 g/dL;
  • Absolute neutrophil count ≥ 1.0 x 10^9/L;
  • Platelets ≥75x 10^9/L;
  • Calculated creatinine clearance ≥30 mL/min as determined by the Cockcroft-Gault equation
  • Adequate hepatic function (with stenting for any obstruction, if required) including the following:
  • Serum bilirubin ≤ 3 x institutional upper limit of normal (ULN);
  • AST (SGOT) / ALT (SGPT) and alkaline phosphatase ≤ 2.5x ULN
  • Following exceptions apply:
  • Patients with documented liver metastases: AST and/or ALT ≤ 5x ULN
  • Patients with documented liver or bone metastases: alkaline phosphatase ≤ 5x ULN.
  • Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.
  • Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
  • Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
  • Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).

Who cannot join

  • Previous treatment with CD137 agonists, immune-checkpoint blockade therapies, anti-PD-1, or anti-PD-L1 therapeutic antibodies (with the exclusion of prior immunotherapy as defined in inclusion criterion 6).
  • Prior therapy for limited-stage SCLC with curative intent.
  • Prior radiotherapy of lung and mediastinal lymph nodes within the past 5 years before the first dose of study drug.
  • Oxygen-dependent medical condition.
  • History or current radiology suggestive of interstitial lung disease (ILD) (including but not limited to idiopathic pulmonary fibrosis (IPF)/usual interstitial pneumonia (UIP)/cryptogenic fibrosing alveolitis (CFA)), non-infectious pneumonitis, drug-induced pneumonitis, idiopathic pneumonitis.
  • Criterion removed.
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  • Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study, or during the follow-up period of an interventional study.
  • Participation in another clinical study with an investigational product within 21 days prior to the first dose of the study treatment.
  • Any concurrent chemotherapy, investigational product (IMP), biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer related conditions (e.g., hormone replacement therapy) is acceptable.
  • Major surgery (as defined by the Investigator) within 4 weeks prior to enrollment into the study; patients must have recovered from effects of any major surgery. Note: Local non-major surgery for palliative intent is acceptable.
  • Active or prior documented autoimmune or inflammatory disorders (including but not limited to diverticulitis [with the exception of diverticulosis], celiac disease, systemic lupus erythematosus, Sarcoidosis, or Wegener's syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis). The following are exceptions to this criterion:
  • Patients with vitiligo or alopecia
  • Patients with hypothyroidism (e.g., following Hashimoto's disease) stable on hormone replacement
  • Patients with controlled Type I diabetes mellitus on an insulin regimen
  • Any chronic skin condition that does not require systemic therapy
  • Patients without active disease in the last 5 years may be included but only after consultation with the study physician.
  • Active, uncontrolled inflammatory bowel disease [e.g. ulcerative colitis or Crohn's disease]. Patients in stable remission for more than 1 year may be included.
  • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, interstitial lung disease, gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
  • History of another primary malignancy except for:
  • Malignancy treated with curative intent and with no known active disease ≥ 3 years before the first dose of IMP and of low potential risk for recurrence
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  • Adequately treated carcinoma in situ without evidence of disease
  • History of active primary immunodeficiency
  • History of allogenic organ or tissue transplantation.
  • Clinical diagnosis of active tuberculosis.
  • Positive testing for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  • Positive testing for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of atezolizumab. The following are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids, or local steroid injections (e.g. intra articular injection)
  • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
  • Steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication)
  • Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 5 months after the last dose of atezolizumab monotherapy.
  • Known allergy or hypersensitivity to the IMP or any of the constituents of the product.
  • Any co-existing medical condition that in the investigator's judgement will substantially increase the risk associated with the patient's participation in the study.
  • Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities.
  • Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts.

Trial locations and contacts

20 sites in 2 countries.

20 sites in 2 countries

Germany18 sites

  • DRK Kliniken Berlin-Mitte

    Berlin, 13359

  • Kliniken der Stadt Köln gGmbH Lungenklinik Köln-Merheim

    Cologne, 51109

  • Universitätsklinikum Carl-Gustav-Carus Dresden

    Dresden, 01307

  • Universitätsklinikum Essen

    Essen, 45147

  • Universitätsmedizin Göttingen

    Göttingen, 37075

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Thoraxklinik am Universitätsklinikum Heidelberg

    Heidelberg, 69126

  • Lungenklinik Hemer

    Hemer, 58675

  • Klinik Löwenstein gGmbH

    Löwenstein, 74245

  • Klinikum Ludwigsburg

    Ludwigsburg, 71640

  • Universitätsmedizin Mainz

    Mainz, 55131

  • Klinikum der Universität München

    München, 80336

  • Klinikum Bogenhausen

    München, 81925

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Münster, 48153

  • Sana Klinikum Offenbach GmbH

    Offenbach, 63069

  • Krankenhaus Barmherzige Brüder

    Regensburg, 93049

  • Vinzent von Paul Kliniken gGmbH Marienhospital Stuttgart

    Stuttgart, 70199

  • Universitätsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Austria2 sites

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt, 9020

  • Kepler Universitätsklinikum, MC III., Pneumologie

    Linz

Other trials in Austria

About this study

Official title: Thoracic RadiothErapy With Atezolizumab in Small Cell lUng canceR Extensive Disease: a Randomized, Open-label, Multicenter Phase II Study

This is a multicenter phase 2 clinical trial to investigate the treatment efficacy and feasibility of combining thoracic radiotherapy (TRT) with the IMpower133 regimen in the upfront treatment of ED SCLC patients. Patients with a response after induction therapy with carboplatin/etoposide and atezolizumab will be included into this study to subsequently receive atezolizumab maintenance therapy and will be randomized to receive TRT or not. This trial aims to i.) increase the efficacy of combined atezolizumab- and chemotherapy by adding radiotherapy and ii.) determine the safety and tolerability of the combination of chemotherapeutic, immunological and radiological treatment in the first-line setting of advanced SCLC, and iii.) to collect tumor tissue as well as blood and stool samples for separate biomarker research project.

Being tested
Atezolizumab, thoracic radiotherapy (TRT)
Keywords
SCLC, thoracic radiotherapy, Atezolizumab

What participants receive

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

  • AtezolizumabDrug

    fixed dose of 1,200 mg as an IV infusion, on day 1, to be repeated every 3 weeks (Q3W)

  • thoracic radiotherapy (TRT)Radiation

    30 Gy in 10 fractions

Study groups in NCT04462276
Study groupRoleWhat they receive
Arm A: Atezolizumab + thoracic radiotherapyExperimentalAtezolizumab at a fixed dose of 1,200 mg as an IV infusion, on day 1, to be repeated every 3 weeks (Q3W) Thoracic radiation therapy (TRT), 30 Gy in 10 fractions
Receives: Drug: Atezolizumab; Radiation: thoracic radiotherapy (TRT)
Arm B: AtezolizumabExperimentalAtezolizumab at a fixed dose of 1,200 mg as an IV infusion, on day 1, to be repeated every 3 weeks (Q3W)
Receives: Drug: Atezolizumab

What is being measured

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

  1. Overall survival (OS)

    time from randomization to death

    Measured: at 24 month after lat patient randomized

Secondary outcomes (10)

  1. 1-year Overall Survival (OS) rate

    OS rate after 1 year after randomization

    Measured: at 1 year after randomization

  2. 2-year Overall Survival (OS) rate

    OS rate after 2 years after randomization

    Measured: at 2 years after randomization

  3. Progression-free survival (PFS)

    PFS is defined as time from randomization to the date of first observed disease progression (investigator assessment according to RECIST 1.1) or death from any cause

    Measured: at study end (approx. 2 years after last patient randomized)

  4. objective response rate (ORR)

    ORR will be assessed according to RECIST 1.1. The objective response rate will be defined as the proportion of allocated / randomized subjects with best response of complete or partial response.

    Measured: at study end (approx. 2 years after last patient randomized)

  5. Intrathoracic tumor control

    rate of intrathoracic progression will be determined via assessing the proportion of allocated / randomized subjects with an intrathoracic progression (investigator assessment according to RECIST 1.1).

    Measured: at study end (approx. 2 years after last patient randomized)

  6. Incidence, nature, causal relationship and severity of Adverse Events

    Incidence, nature, causal relationship and severity of Adverse Events according to CTC v5.0

    Measured: at study end (approx. 2 years after last patient randomized)

  7. Frequency of abnormal laboratory parameters

    Frequency of abnormal laboratory parameters

    Measured: at study end (approx. 2 years after last patient randomized)

  8. frequency of treatment withdrawal

    description of relative and absolute frequencies of treatment withdrawal (either due to adverse events or other reasons), which will be compared between treatment groups

    Measured: at study end (approx. 2 years after last patient randomized)

  9. completion of radiotherapy

    relative and absolute numbers of radiotherapy completers

    Measured: at study end (approx. 2 years after last patient randomized)

  10. Cancer related quality of life (Functional Assessment of Cancer Therapy for patients with Lung cancer (FACT-L))

    Cancer-related quality of life measured via the total- and subscores of FACT-L will be compared between the two treatments by analyzing the mean change from baseline. Score scales are ranging from 0 (minimum) to 4 (maximum).

    Measured: at study end (approx. 2 years after last patient randomized)

Timeline

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

  1. First posted8 Jul 2020
  2. Study start28 Jul 2020
  3. Primary completion2 Sep 2024
  4. Study completion2 Sep 2024

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
Model description
Randomized, open label, multicenter, phase II trial
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04462276
Sponsor's protocol ID
TREASURE
Acronym
TREASURE
Status last verified
Jan 2025
First submitted
28 Jun 2020
Last updated
30 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD will be shared.

Publications

  • Bozorgmehr F, Chung I, Behnisch R, Weykamp F, Adeberg S, Overbeck T, El Shafie R, Maguire N, Koerber SA, Buchmeier EL, Hammer-Hellmig M, Gauler T, Pottgen C, Wermke M, Troost EGC, Kokowski K, Roper B, Reinacher-Schick A, Consdorf NS, Ulmer M, Muller AC, Wehler T, Hey-Koch S, Alt J, Stockinger M, Kuon J, Bischof M, Lamprecht B, Geinitz H, Lerchenmuller C, Kriz J, Rauter M, Raunik W, Schmidt B, Stupavsky A, Kropf-Sanchen C, Schmidtke-Schrezenmeier G, Wiegel T, Tufman A, Manapov F, Merling M, Heussel CP, Polke M, Reck M, Al-Batran SE, Thomas M, Christopoulos P, Rieken S. Consolidative Thoracic Radiotherapy With Atezolizumab Maintenance in Extensive-Stage Small Cell Lung Cancer: The Phase 2 TREASURE Randomized Clinical Trial (AIO-TRK-0320). JAMA Oncol. 2026 Jul 9:e262330. doi: 10.1001/jamaoncol.2026.2330. Online ahead of print.

    PubMed 42424047

  • Bozorgmehr F, Christopoulos P, Chung I, Cvetkovic J, Feisst M, Krisam J, Schneider MA, Heussel CP, Kreuter M, Muller DW, Thomas M, Rieken S. Protocol of the TREASURE study: Thoracic RadiothErapy with Atezolizumab in Small cell lUng canceR Extensive disease - a randomized, open-label, multicenter phase II trial. BMC Cancer. 2022 Sep 24;22(1):1011. doi: 10.1186/s12885-022-10074-9.

    PubMed 36153496

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab and thoracic radiotherapy (TRT) in people with Small Cell Lung Cancer Extensive Stage and Thoracic Radiotherapy, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 20 sites in 2 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 28 inclusion and 36 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: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Germany, Austria. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall survival (OS) (time frame: at 24 month after lat patient randomized). 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 NCT04462276, which also lists 2 linked publications.

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 30 Jan 2025.

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