AzTrials
AzTrials

Non-small Cell Lung Cancer Stage IVPhase 2SAVIMMUNENCT04108026

Immunotherapy in Patient With Poor General Condition

A Phase 2 study testing Durvalumab in people with Non-small Cell Lung Cancer Stage IV, run by Intergroupe Francophone de Cancerologie Thoracique at 20 sites in France.

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

Immunotherapeutic approaches targeting immune checkpoint proteins PD-1/PD-L1 have recently demonstrated clinical efficacy in several cancer types, and have changed the therapeutic landscape in metastatic melanoma or non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-small Cell Lung Cancer Stage IV
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
20 sitesFrance
Study dates
14 Oct 2020to 26 Sep 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must have signed and dated an IEC (Independent Ethic Committee) approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.
  • Subjects must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.
  • Histologically or cytologically-proven NSCLC (squamous or non-squamous). If the diagnosis is cytologically-proven, sufficient material is necessary with at least 100 tumor cells evaluated for PD-L1 IHC (Immunohistochemistry).
  • PD-L1 expression ≥25% of tumor cells as assessed by the local pathology laboratory using protocols validated.
  • Available tumor samples for centralized PD-L1 immunohistochemistry analysis.
  • No EGFR (Epidermal Growth Factor Receptor) mutation and no ALK(Anaplasic Lymphoma Kinase) gene rearrangement.
Show all 22Show fewer
  • Stage IV (8th classification TNM) M1a or M1b or M1c.
  • ECOG (Eastern Cooperative Oncology Group) PS = 2 or 3 despite optimal symptomatic treatment.
  • Body weight >30kg
  • No prior systemic anticancer therapy (chemotherapy, immunotherapy including durvalumab, or EGFR or ALK inhibitors) given as primary therapy for advanced or metastatic disease. Neoadjuvant or adjuvant chemotherapy is not considered as chemotherapy for advanced or metastatic disease.
  • Limited field of radiation for palliation within 2 weeks of the first dose of durvalumab is allowed, provided the lung is not in the radiation field and irradiated lesion(s) cannot be used as target lesions.
  • Age 18-75 years.
  • Measurable tumor disease by CT per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
  • Life expectancy > 8 weeks according to the investigator opinion.
  • Adequate biological functions:
  • neutrophils ≥ 1500/mm3 ; platelets ≥ 75 000/mm3 ; Hemoglobin ≥ 9 g/dL ; Creatinine Clearance > 40 mL/min , AST and ALT ≤ 2,5 ULN unless liver metastases are present, AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤ 5 x ULN, serum bilirubin ≤ 1.5 x ULN except for patients with proved, Gilbert syndrome (≤ 5 x ULN) or patients with hepatic metastases (≤ 3 x ULN).
  • Other investigations detailed in Section 5 must have been performed within the timelines indicated.
  • Protocol treatment is to begin within 7 days of patient inclusion.
  • 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).
  • 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 90 days 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

  • Pure or combined SCLC.
  • Known HER2 (Human Epidermal Growth Factor Receptor), B-Raf, activating tumor mutations, or exon 14 c-MET splice mutations (mesenchymal-epithelial transition), or known ROS1 gene rearrangement.
  • Asymptomatic or symptomatic brain metastasis.
  • Carcinomatous meningitis.
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], 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:
  • Patients with vitiligo or alopecia
Show all 30Show fewer
  • 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 IFCT
  • Patients with celiac disease controlled by diet alone
  • Immunosuppressive treatment including systemic treatment with corticosteroids with greater dose than 10 mg prednisone equivalent daily, within 15 days before enrollment. Inhaled, nasal or topic corticosteroids are allowed.
  • History of allogenic organ transplantation.
  • Stage 4 (very severe, FEV1 (forced expiratory volume at one second) <30% predicted) chronic obstructive pulmonary disease (COPD) according to GOLD classification.
  • NYHA (New York Heart Association) class 4 chronic heart failure
  • Pre-existing interstitial lung.
  • History of another primary malignancy except for :
  • Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of IP (Investigational Product) 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 residual disease Patients with a prostate adenocarcinoma history within the previous 5 years could be included in case of localized prostate cancer.
  • Living attenuated vaccine received within the 30 previous days.
  • Received any other experimental treatment or participation to any other therapeutic clinical trial.
  • Known allergy or hypersensitivity to any of the study drug or any of the study drug excipients.
  • Any concurrent chemotherapy, IP, 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 surgical procedure within 28 days prior to the first dose of IP or planned surgical procedure during treatment.
  • 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/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs (Adverse Events) or compromise the ability of the patient to give written informed consent.
  • Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen (HBsAg) result) and hepatitis C,. 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. History of active tuberculosis or evident primo-infection for which there is no record or evidence of an active anti-tuberculous treatment (please consult IFCT in case of doubt).
  • Patient with human immunodeficiency virus (positive HIV ½ antibodies)
  • Any condition that, in the opinion of investigator, could compromise the adherence to treatment and follow-up.
  • Mental illness or psychological condition, which in the opinion of investigator could compromise the expression of the informed consent.
  • No public health insurance.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

France20 sites

  • Besançon - CHU

    Besançon

  • Hôpital Ambroise Paré - Pneumologie

    Boulogne

  • Caen - CHU Côte de Nacre

    Caen, 14000

  • CH

    Colmar

  • CHRU Grenoble

    Grenoble

  • Centre Hospitalier - Pneumologie

    Le Mans, 72000

  • CHRU de Lille

    Lille

  • AP-HM Hopital Nord

    Marseille

  • Montpellier - CHRU

    Montpellier, 34295

  • GRH Mulhouse Sud-Alsace

    Mulhouse

  • Nancy - Institut de Cancérologie de Lorraine

    Nancy

  • Nantes - ICO Site René Gauducheau

    Nantes, 44805

  • CHR d'Orléans La Source

    Orléans

  • AP-HP Hopital Tenon - Pneumologie

    Paris, 75020

  • Paris - APHP Bichat

    Paris

  • Paris - Curie

    Paris

  • Lyon - URCOT

    Pierre-Bénite

  • CHU Strasbourg

    Strasbourg

  • CHU Toulouse - Pneumologie

    Toulouse

  • CHU Tours - Pneumologie

    Tours

Other trials in France

About this study

Official title: A Phase II Single-arm Trial Evaluating Safety and Efficacy of Durvalumab in ECOG Performance Status 2-3, Treatment-naive, Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC) and High PD-L1 Tumor Expression

Immunotherapeutic approaches targeting immune checkpoint proteins PD-1/PD-L1 have recently demonstrated clinical efficacy in several cancer types, and have changed the therapeutic landscape in metastatic melanoma or non-small cell lung cancer (NSCLC).

The monoclonal anti-PD-1 antibody nivolumab has been registered by both FDA (Food and Drug Administration) and EMA (European Medicine Agency), for metastatic NSCLC patients, after failure of a prior platinum-based chemotherapy.

Read more

The approval was based on the results of phase III clinical trials in metastatic NSCLC. But all the trials only enrolled patients with good general condition, PS (Performance Status) 0 or 1. However, the prevalence of poor PS patients at time of diagnosis is high in lung cancer patients.

For patients with metastatic NSCLC and PS 3, there is no standard treatment except best supportive care, since all trials that accrued unselected PS 3 patients fail to prove any survival advantage, and most PS >3 patients die within 2 to 4 months from diagnosis. Indeed, these patients are currently excluded from clinical trials. Specific dedicated clinical trials and treatment guidelines for this patient population are urgently needed, taking into account for the high prevalence of such patients.

Being tested
Durvalumab
Keywords
IFCT, Savimmune, Non small cell Lung Cancer, PS, Poor General condition, Lung Cancer, Durvalumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

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

Study groups in NCT04108026
Study groupRoleWhat they receive
ImmunotherapyExperimentalDurvalumab 1500 mg every 4 weeks until the progression of disease, discontinuation due to toxicity or withdrawal of consent, for a maximum duration of 2 years.
Receives: Drug: Durvalumab

What is being measured

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

  1. Proportion of patients experiencing Grade 3-5 Treatment Related Adverse Event at 8 weeks of durvalumab

    Measured: 8 weeks

Secondary outcomes (9)

  1. Incidence, type and severity of adverse event

    The maximum grade will be summarized by frequency and proportion of total patients, by system organ class and NCI-CTC, Version 5.0 categories.

    Measured: From time of informed consent through treatment period (24 months) or up to 100 days post last dose of study treatment

  2. Disease Control Rate

    Percentage of patients with objective response or stable disease according to RECIST 1.1 in the intent to treat population

    Measured: 8 weeks

  3. Objective Response Rate according to BICR (Blinded Independent Central Review) and investigators

    Percentage of patients with objective response according to RECIST 1.1 in the intent to treat population

    Measured: 8 weeks (confirmed at 16 weeks)

  4. Progression free survival

    Time between the date of durvalumab initiation and the first date of documented progression or death due to any cause, whichever occurs first.

    Measured: 6 and 12 months

  5. Overall survival

    Time between the date of durvalumab initiation and the date of death due to any cause, whichever occurs first.

    Measured: 6 and 12 months

  6. Performance status improvement rate

    Proportion of per-protocol patients whose PS during durvalumab treatment was improved from baseline

    Measured: From time of randomisation through treatment period (24 months)

  7. Evaluate the Quality of life

    EORTC QLQ-C30 +LC13 (Qualify of Life Questionnaire C30 + Lung Cancer 13) questionnaire

    Measured: From time of randomisation through treatment period (24 months)

  8. Centrally-assessed PD-L1 tumor expression Prognostic and predictive value

    Measured: Baseline only

  9. Evaluate the Quality of life

    EQ-5D (EuroQol 5 Dimensions) questionnaire

    Measured: From time of randomisation through treatment period (24 months)

Timeline

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

  1. First posted27 Sep 2019
  2. Study start14 Oct 2020
  3. Primary completion30 Nov 2023
  4. Study completion26 Sep 2025

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
NCT04108026
Sponsor's protocol ID
IFCT-1802
Acronym
SAVIMMUNE
Status last verified
Sep 2025
First submitted
24 Sep 2019
Last updated
3 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab in people with Non-small Cell Lung Cancer Stage IV, run by Intergroupe Francophone de Cancerologie Thoracique at 20 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 22 inclusion and 30 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 3 Oct 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 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 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?

Proportion of patients experiencing Grade 3-5 Treatment Related Adverse Event at 8 weeks of durvalumab (time frame: 8 weeks). 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 NCT04108026.

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 3 Oct 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in