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Carcinoma, Non-Small-Cell LungPhase 2IONESCONCT03030131

Immune Neoadjuvant Therapy Study of Durvalumab in Early Stage Non-small Cell Lung Cancer

A Phase 2 study testing Durvalumab in people with Carcinoma, Non-Small-Cell Lung, run by Intergroupe Francophone de Cancerologie Thoracique at 31 sites in France.

Terminated

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

Official record
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Trial summary

Lung cancer is still the leading cause of cancer related-deaths worldwide, with an overall all-stage 5-year survival of approximately 17%. The primary treatment of early stage (I-IIIA) NSCLC is curative surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
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
50 participants
Where
31 sitesFrance
Study dates
12 Jan 2017to 28 Aug 2019
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

  • Histologically confirmed diagnosis of primary non-small cell carcinoma of the lung.
  • Tissue block of diagnosis must be available for submission after inclusion (one HES slide and one paraffin embedded block).
  • Patients must be classified clinically as Stage IB (only T = 4 cm in greatest dimension, N0), Stage IIA (T2b,N0) and some of Stage IIB : (T1-2,N1) and (T3 : > 5 cm and ≤ 7 cm in greatest dimension surrounded by lung or associated with separate tumor nodule(s) in the same lobe but without mediastinum or chest wall involvements, or superior sulcus tumors, N0) on the basis of clinical evaluation (8th classification TNM, UICC 2015). In case of invasion of the main bronchus (distance < 2 cm from carina), a biopsy of the carina is required. A pre-surgical PET scan of the thorax and a MRI or CT scan of the brain as well as thorax abdomen pelvis CT scan must be done prior to surgery and before inclusion. If preoperative CT and/or PET are suspicious for mediastinal nodal involvement, invasive mediastinal staging with mediastinoscopy or EBUS-TBNA must be performed. Station 5 or 6 lymph nodes may be accessed by anterior mediastinotomy or VATS.
  • Pre-operative (neo-adjuvant) platinum based or other chemotherapy except the treatment of the protocol is not permissible. Pre-operative radiation therapy is not permissible
  • The patient must have an ECOG performance status of 0, 1.
  • Hematology (done within 14 days prior to inclusion and with values within the ranges specified below): If anemic, patients should be asymptomatic and should not be decompensated. Transfusions are permissible.
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  • Haemoglobin ≥ 9,0 g/dL Absolute neutrophil count > 1.5 x 109/L or > 1,500/µl Platelets > 100 x 109/L or > 100,000/µl
  • Biochemistry (done within 14 days prior to inclusion and with values within the ranges specified below): Total bilirubin* within normal institutional limits Alkaline phosphatase < 2.5 x institutional upper limit of normal AST(SGOT) and ALT(SGPT) < 2.5 x institutional upper limit of normal Creatinine Clearance > 40 ml/min TSH within normal institutional limits
  • excluding Gilbert's syndrome
  • Creatinine clearance to be measured directly by 24 hour urine sampling or as calculated by Cockcroft Formula:
  • Females: GFR = 1.04 x (140-age) x weight in kg serum creatinine in μmol/L Males: GFR = 1.23 x (140-age) x weight in kg serum creatinine in μmol/L
  • Other investigations detailed in Section 6 must have been performed within the timelines indicated.
  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to inclusion in the trial to document their willingness to participate.
  • Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients included on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
  • Protocol treatment is to begin within 7 days of patient inclusion
  • Age of at least 18 years.
  • Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: ≥60 years old and no menses for ≥ 1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.
  • Females of childbearing potential who are sexually active with a nonsterilized male partner or men who are sexually active with women of childbearing potential must use a highly effective method of contraception prior the first dose of investigational product, and must agree to continue using such precautions for 4 months after the final dose of investigational product. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.

Who cannot join

  • Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumours curatively treated with no evidence of disease for > 5 years following the end of treatment and which, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy.
  • A combination of small cell and non-small cell lung cancer or pulmonary carcinoid tumour.
  • History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. NOTE: patients with Grave's disease and/or psoriasis not requiring systemic therapy within the last two years from inclusion are not excluded.
  • History of primary immunodeficiency, history of allogenic organ transplant, use of immunosuppressive agents within 28 days of inclusion* or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy.
  • NOTE: Intranasal/inhaled corticosteroids or systemic steroids that do not to exceed 10 mg/day of prednisone or equivalent dose of an alternative corticosteroid are permissible.
  • Live attenuated vaccination administered within 30 days prior to inclusion.
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  • History of hypersensitivity to durvalumab or any excipient.
  • Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history, even if controlled, should have a LVEF > 50% within 12 weeks prior to inclusion.
  • Concurrent treatment with other investigational drugs or anti-cancer therapy.
  • Patients with active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol. This includes but is not limited to:
  • known prior history of tuberculosis;
  • known acute hepatitis B or C by serological evaluation;
  • known Human immunodeficiency virus infection.
  • Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
  • Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab
  • Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
  • Known history of previous clinical diagnosis of tuberculosis
  • Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

France31 sites

  • Amiens - Clinique de l'Europe

    Amiens

  • Argenteuil - CH

    Argenteuil

  • Bayonne - CH

    Bayonne

  • Bordeaux - Institut Bergonié

    Bordeaux

  • Caen - CHU

    Caen

  • Caen - CRLCC

    Caen

  • Chauny - CH

    Chauny

  • Clermont-Ferrand - CHU

    Clermont-Ferrand

  • Cornebarrieu - Clinique des Cèdres

    Cornebarrieu

  • Grenoble - CHU

    Grenoble

  • Le Mans - CHG

    Le Mans

  • Limoges - CHU

    Limoges

  • Mantes La Jolie - CH

    Mantes-la-Jolie

  • AP-HM Hopital Nord

    Marseille

  • Marseille - Hôpital Européen

    Marseille

  • Metz - Hôpital Robert Schuman

    Metz

  • Mulhouse - CH

    Mulhouse, 68000

  • Nancy - Polyclinique Gentilly

    Nancy

  • Nantes - CRLCC

    Nantes

  • Paris - Hopital Tenon

    Paris, 75020

  • Paris - HEGP

    Paris

  • Paris - Hôpital Cochin

    Paris

  • Paris - Montsouris

    Paris

  • Paris - Saint Joseph

    Paris

  • Paris Bichat

    Paris

  • Pau - CHG

    Pau

  • Centre René Huguenin

    Saint-Cloud

  • Institut de Cancérologie de l'Ouest - site René Gauducheau

    Saint-Herblain

  • Saint-Quentin - CH

    Saint-Quentin

  • Strasbourg - NHC

    Strasbourg, 63000

  • Toulouse - CHU Larrey

    Toulouse

Other trials in France

About this study

Official title: A Phase II Prospective Immune Neoadjuvant Therapy Study od Durvalumab (MEDI4736) in Early Stage Non-small Cell Lung Cancer

Lung cancer is still the leading cause of cancer related-deaths worldwide, with an overall all-stage 5-year survival of approximately 17%. The primary treatment of early stage (I-IIIA) NSCLC is curative surgery. Although patients treated with curative surgery have a better prognosis, the 5-year survival for patients treated with surgery alone remains low, ranging from 67% (stage IA) to 23% (stage IIIA). Several randomized trials comparing postoperative chemotherapy versus no chemotherapy have shown a significant overall survival benefit from postoperative chemotherapy in completely resected patients with NSCLC stage II and IIIA. Likewise other randomized trials have demonstrated preoperative chemotherapy improves survival and recently the analyses also based on individual patients data of 15 randomized trials showed a significant benefit of preoperative chemotherapy on survival with the same survival improvement of 5% at 5 years. Then, neoadjuvant chemotherapy has also become accepted in many countries.

Targeting of PD-1 receptors and its ligand PD-L1, and inhibiting their engagement is an attractive therapeutic option in the early stage NSCLC, which may reactivate host immune responses and enable longterm tumor control.

Being tested
Durvalumab
Keywords
IFCT, neodjuvant, immune therapy, Non small cell lung cancer
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.

  • DurvalumabDrug

    Also called MEDI4736

    durvalumab 750 mg IV Day1, 15, 29

Study groups in NCT03030131
Study groupRoleWhat they receive
DurvalumabExperimentaldurvalumab 750 mg IV J1, J15, J29
Receives: Drug: Durvalumab

What is being measured

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

  1. Surgical resection R0

    Patient percentage of surgical resection R0 after a maximum of 3 cycles of immune therapy

    Measured: 2 months

Secondary outcomes (9)

  1. Response Rate (recist 1.1)

    Measured: After 28 days (3 cycles of immune therapy maximum)

  2. Metabolic response rate on TEP-FDG

    Measured: After 28 days (3 cycles of immune therapy maximum)

  3. Delay between surgery and start of treatment

    Measured: After 28 days (3 cycles of immune therapy maximum)

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: 1 month

  5. Disease-Free Survival (DFS)

    Time from the date of inclusion to the date of first documented disease relapse or the occurrence of a new invasive primary malignancy or death from any cause

    Measured: 1 year

  6. Overall survival (OS)

    Time from the inclusion to the date of death of any cause, or censored at their last known alive date

    Measured: 1 year

  7. Evaluation of predictive/prognostic value of PD-1/PD-L1 expression

    Measured: 1 month

  8. Evaluation of changes in plasma/serum cytokines and other biomarkers

    Measured: 1 month

  9. Major Pathological Response

    Measured: 2 months

Timeline

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

  1. First posted24 Jan 2017 (estimated)
  2. Study start12 Jan 2017
  3. Primary completion28 Aug 2019
  4. Study completion28 Aug 2019

Why it stopped: Definitive discontinuation according to safety monitoring of death from the 46th patient onwards.

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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03030131
Sponsor's protocol ID
IFCT-1601
Acronym
IONESCO
Status last verified
Mar 2023
First submitted
12 Jan 2017
Last updated
14 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wislez M, Mazieres J, Lavole A, Zalcman G, Carre O, Egenod T, Caliandro R, Dubos-Arvis C, Jeannin G, Molinier O, Massiani MA, Langlais A, Morin F, Le Pimpec Barthes F, Brouchet L, Assouad J, Milleron B, Damotte D, Antoine M, Westeel V. Neoadjuvant durvalumab for resectable non-small-cell lung cancer (NSCLC): results from a multicenter study (IFCT-1601 IONESCO). J Immunother Cancer. 2022 Oct;10(10):e005636. doi: 10.1136/jitc-2022-005636.

    PubMed 36270733

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab in people with Carcinoma, Non-Small-Cell Lung, run by Intergroupe Francophone de Cancerologie Thoracique at 31 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 18 inclusion and 19 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 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 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?

The study was stopped early (reason given: Definitive discontinuation according to safety monitoring of death from the 46th patient onwards.). 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?

Surgical resection R0 (time frame: 2 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 NCT03030131, which also lists 1 linked publication.

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 14 Mar 2023.

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