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Small Cell Lung CarcinomaPhase 2DURVALUNGNCT05617963

Durvalumab Maintenance After Thoracic Chemoradiotherapy in Frail Small Cell Lung Cancer Patients Whose Disease is Limited to the Thorax

A Phase 2 study testing Durvalumab in people with Small Cell Lung Carcinoma, run by UNICANCER at 32 sites in France.

Active, not recruiting

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

Official record
Search all trials

Trial summary

This study is an academic-lead, open-label, multicenter, randomized phase II trial for frail limited disease Small Cell Lung Cancer (LD-SCLC) patients. Frail conditions are: Eastern Cooperative Oncology Group performance status (ECOG PS) 2 or ECOG PS 0-1 and older than 70 or ECOG PS 0-1 and did not receive a… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Carcinoma
What is being tested?
Durvalumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
32 sitesFrance
Study dates
24 Mar 2023to 24 Feb 2030
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

  • Criteria for Screening
  • Patient must have signed a first written informed consent form prior to screening visit and to any trial specific procedures.
  • Histological confirmation of SCLC.
  • Limited disease (T0-T4, N0-N3 and M0) according to the TNM classification 8th edition or to the VALSG 2-stage classification. As per standard guidelines a complete radiological evaluation has to be performed within 28 days before the start of induction chemotherapy including all the radiological exams below:
  • Total body PET- scan.
  • Contrast enhanced CT-scan of thorax and upper abdomen.
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  • Contrast enhanced MRI or CT-scan of brain.
  • Measurable disease according to RECIST v1.1 criteria.
  • Patients must not have been previously treated for the SCLC. Note: patients who have already begun the initial CRT are eligible.
  • Patients ≥18 years old.
  • Body weight >30 kg.
  • Patients can be candidate to concomitant or sequential thoracic CRT by IMRT. Patients have to receive at least 60 Gy (one-daily fraction of 1.8-2 Gy) or 45 Gy twice daily (1.5 Gy per fraction) combined with cisplatin-etoposide regimen or with carboplatin AUC5 to AUC6 etoposide regimen.
  • Patients that received previous thorax radiotherapy may be eligible if they can receive the CRT schedule planned in the clinical study according to previous irradiation fields and, in any case, after the medical monitor agreement.
  • Women of childbearing potential must have a negative serum beta-HCG test before the beginning of the trial, during the study treatment and for a period of at least 3 months after the last administration of the experimental drug.
  • All sexually active men and women of childbearing potential must use an effective contraception method for the duration of study treatment and for 3 months after completing treatment.
  • Patients affiliated to the social security system.
  • Patient must be willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.
  • Criteria for Inclusion:
  • Patient must have signed a second written informed consent form prior to inclusion and to any specific trial procedure.
  • Patients must have completed concomitant or sequential thoracic CRT by IMRT:
  • Patients that received concomitant or sequential thoracic CRT must have received at least 60 Gy (one-daily fraction of 1.8-2 Gy) or 45 Gy twice daily (1.5 Gy per fraction) combined with cisplatin-etoposide regimen or with carboplatin AUC5 to AUC6 etoposide regimen.
  • Confirmation of disease control (SD, CR or PR) at radiological assessment with contrast enhanced thorax and upper abdomen CT-scan or PET-CT and contrast enhanced brain CT-scan or MRI after the thoracic CRT according to RECIST v1.1.
  • Use of brain MRI in case of PCI avoidance is mandatory. PCI has to be prescribed according to the investigator's choice and the local recommendations.
  • Body weight >30 kg
  • Patients must belong to one of these groups at the screening visit after the thoracic CRT :
  • ECOG PS 2.
  • ECOG PS 0-1 and older than 70.
  • ECOG PS 0-1 and who did not receive a concomitant thoracic CRT because of comorbidities (radiotherapy beginning before D1C3 of chemotherapy).
  • Adequate haematological function
  • Haemoglobin >9 g/dL.
  • Platelet count >100 x 10⁹L.
  • Neutrophil count >1.5 x 10⁹L.
  • Adequate renal function with a creatinine clearance ≥40 ml/min calculated with the Cockcroft-Gault formula.
  • Adequate hepatic function:
  • Total bilirubin <1.5 Upper limit of normal (ULN).
  • AST and ALT <2.5 ULN.
  • Alkaline phosphatase <2.5 ULN.
  • HRQoL questionnaire performed.
  • Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.

Who cannot join

  • History of another primary malignancy except for
  • Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of durvalumab 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.
  • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness 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.
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
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  • Patients with vitiligo or alopecia
  • Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
  • 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
  • Patients with celiac disease controlled by diet alone.
  • Any concurrent chemotherapy, immune checkpoint inhibitors, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
  • History of leptomeningeal carcinomatosis.
  • Major surgical procedure (as defined by the Investigator) including surgical resection of the primary disease, within 28 days prior to the first dose of IMP.
  • History of allogenic organ transplantation.
  • History of active primary immunodeficiency.
  • Known active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, or TB testing in line with local practice) and hepatitis B and hepatitis C (positive hepatitis C virus [HCV] antibody, hepatitis B virus [HBV] surface antigen [HBsAg] or HBV core antibody [anti-HBc]).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 HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Patients known to have been tested positive for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies) are not eligible.
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. 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).
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab.
  • Note: included patients should not receive live vaccine whilst receiving durvalumab and up to 30 days after the last dose of durvalumab.
  • Patients with known or suspected hypersensitivity to durvalumab or any of its excipients.
  • Patients who participated in another therapeutic trial within the 30 days prior to the start of the trial (screening phase included).
  • Prior randomisation or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.
  • Female patients who are pregnant or breast feeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.
  • Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
  • Persons deprived of their liberty or under protective custody or guardianship.

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

France32 sites

  • Centre de Radiothérapie du Pays d'Aix

    Aix-en-Provence

  • Centre Hospitalier du Pays d'Aix

    Aix-en-Provence

  • Institut du Cancer Avignon-Provence

    Avignon

  • Centre d'Oncologie du Pays Basque

    Bayonne

  • CH de la côte Basque

    Bayonne

  • Clinique Belharra

    Bayonne

  • Centre François Baclesse

    Caen

  • CHU de CAEN

    Caen

  • Centre Jean Perrin

    Clermont-Ferrand

  • CHI Créteil

    Créteil

  • Centre George François Leclerc

    Dijon

  • Centre Oscar Lambret

    Lille

  • CHU Dupuytren

    Limoges

  • Polyclinique de Limoges -Site Clinique Chénieux

    Limoges

  • Groupe Hospitalier Bretagne Sud

    Lorient

  • Centre Léon Bérard

    Lyon

  • APHM - Hôpital Nord

    Marseille

  • Hopital européen Marseille

    Marseille

  • Hopital privé Clairval

    Marseille

  • Institut Paoli-Calmettes

    Marseille

  • Institut régional du Cancer de Montpellier - ICM Val d'Aurelle

    Montpellier

  • Hopital privé du Confluent

    Nantes

  • Centre Lacassagne

    Nice

  • Hôpital Tenon APHP

    Paris

  • Institut Curie

    Paris

  • CARIO

    Plérin

  • Institut Godinot

    Reims

  • Centre Henri Becquerel

    Rouen

  • CH Saint Brieuc

    Saint-Brieuc

  • Clinique Mutualiste de l'Estuaire

    Saint-Nazaire

  • Centre d'oncologie Saint Yves

    Vannes

  • Hopital Nord Ouest - Villefranche sur Saône

    Villefranche-sur-Saône

Other trials in France

About this study

Official title: A Phase II Study of Durvalumab (MEDI 4736) Maintenance in Frail Limited Disease Small Cell Lung Cancer Patients After Thoracic Chemoradiotherapy (CRT)

This study is an academic-lead, open-label, multicenter, randomized phase II trial for frail limited disease Small Cell Lung Cancer (LD-SCLC) patients.

Frail conditions are: Eastern Cooperative Oncology Group performance status (ECOG PS) 2 or ECOG PS 0-1 and older than 70 or ECOG PS 0-1 and did not receive a concomitant thoracic chemo-radiotherapy (CRT) because of comorbidities.

Read more

During the screening phase, patients complete either the standard concomitant or sequential thoracic CRT and cisplatin-etoposide regimen or carboplatin AUC5 to AUC6 etoposide regimen.

Patients showing a disease control (defined as stable disease [SD], partial response [PR], or complete response [CR] according to RECIST v1.1) at the radiological evaluation performed after the end of thoracic CRT can receive prophylactic cranial irradiation (PCI) as per local practice. They will then be treated by durvalumab every 4 weeks.

DURVALUNG study aims to evaluate the activity of durvalumab maintenance treatment in frail LD-SCLC patients who have not progressed following platinum-based concomitant or sequential CRT.

Read the detailed description

Small Cell Lung Cancer (SCLC) is a rare tumor, accounting nowadays for 10-15% of all new lung cancer diagnosis. Approximately one third of patients present with limited disease (LD-SCLC) confined to the chest with a median survival from 18 to 24 months and a 5-year survival rate between 20% and 25%. A platinum-based chemotherapy combined with etoposide and a concurrent thoracic radiotherapy represents the standard of care for LD-SCLC treatment with a median PFS of 12 months. However, sequential radiotherapy may be preferable for patients with poor performance status or having comorbidity predisposing to a worst tolerability. Clinical evidence supports the immunogenicity of SCLC and the involvement of immune activity in SCLC development and prognosis.

Several immune checkpoint inhibitors got the approbation in first and further lines for the advanced SCLC in the last decade. The most important results have been achieved in the first-line setting for patients receiving a combination of platinum - etoposide chemotherapy and an anti-PD1/PDL-1 inhibitor compared to chemotherapy alone. However, despite these were the first positive results after a while in this setting, the modest absolute benefit showed (3 months) have to be taking into account. The possibility to enhance the immunotherapy efficacy in SCLC field with the radiotherapy administered as part of the standard treatment for a LD-SCLC seems to be a great opportunity. In the PACIFIC trial, the sequential administration of durvalumab in patients with locally advanced, unresectable, stage III Non-Small-Cell Lung Cancer (NSCLC) whose disease had not progressed following platinum-based concurrent thoracic CRT showed a dramatic overall survival improvement compared to placebo, with manageable toxicities. The ADRIATIC phase III trial, is currently recruiting LD-SCLC patients not progressing after the concomitant CRT (NCT03703297). Patients are randomized to receive durvalumab, durvalumab plus tremelimumab or placebo as maintenance treatment. In this trial, only ECOG PS 0-1 patients able to receive a concomitant CRT are eligible. However, in our clinical practice, LD-SCLC patients may not respect these criteria due to the aggressiveness of cancer and comorbidities.

Thus, DURVALUNG study aims to evaluate the activity of durvalumab maintenance treatment in frail LD-SCLC patients who have not progressed following platinum-based concomitant or sequential CRT.

Being tested
Durvalumab
Keywords
immunotherapy, maintenance treatment
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.

  • DurvalumabDrug

    Patients showing a disease control (defined as stable disease [SD], partial response [PR], or complete response [CR] according to RECIST v1.1) at the radiological evaluation performed after the end of thoracic CRT will receive durvalumab intravenously 1500 mg every 4 weeks until disease progression, unacceptable toxicity, death or patient's decision for a maximum of 24 months.

Study groups in NCT05617963
Study groupRoleWhat they receive
Durvalumab maintenanceOtherPatients will receive durvalumab intravenously 1500 mg every 4 weeks until disease progression, unacceptable toxicity, death or patient's decision for a maximum of 24 months. For patients receiving prophylactic cranial irradiation as per standard of care, the first dose of durvalumab may be delayed by up to 42 days from the end of the CRT. Radiological assessments will be planned every 12 weeks (± 7 days) of maintenance treatment. The first dose of durvalumab should be administered within 3 days of inclusion.
Receives: Drug: Durvalumab

What is being measured

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

  1. Progression-free survival

    The progression-free survival (PFS) is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.

    Measured: From inclusion to disease progression or death, up to 3.5 years

Secondary outcomes (4)

  1. Overall survival

    The overall survival (OS) is the length of time from randomization that patients enrolled in the study are still alive.

    Measured: From inclusion to death, up to 3.5 years

  2. Occurrence of adverse events coded using NCI CTC-AE version 5.0.(Safety )

    Occurrence of adverse events coded using NCI CTC-AE version 5.0. The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.

    Measured: Throughout study completion, up to 4 years

  3. Quality of life questionnaire - Core 30 (QLQ-C30)

    Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.

    The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.

    All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

    Measured: At inclusion before treatment start and every 4 weeks for the first year from inclusion and then every 12 weeks until end of treatment or death, up to 2 years

  4. Quality of life questionnaire - Lung cancer module (QLQ-LC13)

    The QLQ-LC13 contains 13 items to assess both multi-item and single-item measures of lung cancer-associated symptoms (coughing, haemoptysis, dyspnoea, and pain) and side-effects from conventional chemo- and radiotherapy (hair loss, neuropathy, sore mouth, and dysphagia). All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much).

    Measured: At inclusion before treatment start and every 4 weeks for the first year from randomization and then every 12 weeks until end of treatment or death, up to 2 years

Timeline

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

  1. First posted16 Nov 2022
  2. Study start24 Mar 2023
  3. Primary completion24 Feb 2028 (estimated)
  4. Study completion24 Feb 2030 (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
Not applicable
Intervention model
Single group
Model description
Patients showing a disease control after the end of thoracic CRT will receive durvalumab intravenously 1500 mg every 4 weeks until disease progression, unacceptable toxicity, death, patient's decision, or for a maximum of 24 months (26 doses/cycles).
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05617963
Sponsor's protocol ID
UC-IMM-2106
Acronym
DURVALUNG
Status last verified
Apr 2026
First submitted
8 Nov 2022
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab in people with Small Cell Lung Carcinoma, run by UNICANCER at 32 sites in France.

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 39 inclusion and 29 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 23 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 32 sites in France. 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?

Progression-free survival (time frame: From inclusion to disease progression or death, up to 3.5 years). 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 NCT05617963.

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 23 Apr 2026.

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