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Non-small Cell Lung CancerPhase 2VinMetAtezoNCT03801304

Trial to Evaluate Safety and Efficacy of Vinorelbine With Metronomic Administration in Combination With Atezolizumab as Second-line Treatment for Patients With Stage IV Non-small Cell Lung Cancer

A Phase 2 study testing Atezolizumab and Vinorelbine in people with Non-small Cell Lung Cancer, run by University Hospital, Brest at 13 sites in France.

Completed

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

Official record
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Trial summary

The majority of patients diagnosed with advanced NSCLC are treated with platinum-doublet chemotherapy regimens, except those harboring specific oncogenic drivers such as epidermal growth-factor-receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Atezolizumab and Vinorelbine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
13 sitesFrance
Study dates
24 Jan 2019to 23 Feb 2022
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 NSCLC;
  • Locally advanced and/or metastatic stage IV NSCLC (according to American Joint Committee on Cancers) or recurrent NSCLC);
  • Patients without activating EGFR mutation or ALK rearrangement and ROS1 fusions.
  • Subject has provided a formalin-fixed tumor-tissue sample of a tumor-lesion biopsy, either at the time of or after metastatic disease was diagnosed AND from a site not previously irradiated to assess for PDL1 status. Archived tissue may be acceptable or PDL1 status known;
  • Progressive disease after first-line platinum-doublet-based chemotherapy according to RECIST V.1.1 with measurable lesion (RECIST V1.1);
  • Age ≥18 years, either sex;
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  • Eastern Collaborative Oncology Group Performance status (ECOG PS) 0, 1 or 2;
  • Life expectancy exceeds 12 weeks;
  • No history of other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or basal cell or spinocellular carcinoma of the skin;
  • Adequate organ function, demonstrated by the following laboratory results within 3 weeks prior to teatment: Normal hepatic function: bilirubin <1.5 × normal (N), Alanine aminotransferase and Aspartate aminotransferase <2.5 × N or <5 × N if liver metastasis is present;
  • Normal renal function (calculated creatinine clearance ≥45 mL/min);
  • Normal calcemia;
  • Normal hematological function (polynuclear neutrophils >1.5 G/L, platelets >100 G/L and hemoglobin>8g/dl);
  • Women of child-bearing potential must use effective contraception;
  • Men might be surgically sterile or accept to use an effective contraceptive procedure during and until 6 months after the treatment;
  • Written informed consent to participate in the study
  • Patient with social insurance

Who cannot join

  • ECOG PS >2;
  • Known hypersensitivity to immunotherapy;
  • Small-cell lung cancer, bronchioloalveolar cancer, neuroendocrine cancer;
  • Tumor harbors EGFR-sensitizing (activating) mutations or ALK translocations or ROS1 fusions and that justify treatment with targeted therapy ;
  • Chemotherapy, hormonotherapy, immunotherapy or tyrosine-kinase inhibitors within the past 4 weeks prior to treatment with the trial drug;
  • Radiotherapy (except bone or brain) within the past 3 months prior to baseline imaging;
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  • Medical contraindication to oral vinorelbine;
  • Persistence of clinical adverse events with a grade > 2 related to prior treatment;
  • Active brain metastases (e.g. stable for <4 weeks, no adequate previous radiotherapy, symptomatic, requiring anticonvulsants or corticosteroids)
  • Concurrent radiotherapy, except for palliative bone irradiation.
  • Other concurrent severe illnesses (congestive heart failure, unstable angina, significant arrhythmia or myocardial infarction <12 months before study entry);
  • Active or prior documented autoimmune or inflammatory disorders;
  • Active B hepatitis, HIV infection …;
  • Psychiatric or neurological disorders preventing the patient from understanding the nature of the trial;
  • Grade-3 peripheral neuropathy;
  • Uncontrolled infection;
  • Interstitial lung disease or pneumonitis requiring steroid management;
  • Corticosteroid therapy exceeding 10 mg/day;
  • Other severe organic disorders not allowing inclusion in the trial;
  • Malabsorption syndrome;
  • Pregnancy or breast-feeding;
  • Follow-up not possible; and incarcerated or institutionalized patients.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

France13 sites

  • CH Aix en Provence

    Aix-en-Provence, France

  • CHRU de Brest - Hôpital Morvan

    Brest, France, 29609

  • CLCC Caen

    Caen, France

  • CH de Créteil

    Créteil, France, 94010

  • Ch La Roche Sur Yon

    La Roche-sur-Yon, France, 85000

  • CHU de Limoges - Hôpital DUPUYTREN

    Limoges, France, 87042

  • CH MEAUX

    Meaux, France

  • CH Pringy

    Pringy, France

  • CH Quimper

    Quimper, France

  • CHU de Rennes

    Rennes, France, 35033

  • CHU Rouen

    Rouen, France

  • CH Saint-Brieuc

    Saint-Brieuc, France

  • Hia Saint Anne

    Toulon, France, 83041

Other trials in France

About this study

Official title: Open Label Phase II Trial to Evaluate Safety and Efficacy of Vinorelbine With Metronomic Administration in Combination With Atezolizumab as Second-line Treatment for Patients With Stage IV Non-small Cell Lung Cancer

The majority of patients diagnosed with advanced NSCLC are treated with platinum-doublet chemotherapy regimens, except those harboring specific oncogenic drivers such as epidermal growth-factor-receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. In the second-line setting, response rates remain low and median survival rarely exceeds 10 months.

Over the past few years, several checkpoint inhibitors targeting programmed cell death protein-1 (PD1) or its ligand (PDL1) used as second-line therapies generated evidence of improving survival and, more recently, as first-line NSCLC treatment.

Read more

Although pembrolizumab (anti-PD1) was recently approved as first-line treatment for patients with at least 50% of their NSCLC cells expressing PDL1, many patients are still not benefiting from this first-line agent.

For patients with relapsed NSCLC, atezolizumab (anti-PDL1) prolonged survival compared to docetaxel in the phase II POPLAR and phase III OAK trials. Novel concepts of synergic action between immunotherapy and chemotherapy have emerged recently. However, those types of treatments are given for different durations: chemotherapy is allowed for only a short period (rarely exceeding 6 cycles), while anti-PDL1 can be continued for several months until loss of its clinical benefit.

Metronomic chemotherapy is defined as low-dose and frequent chemotherapy administration, without prolonged drug-free breaks. Metronomic administration of oral vinorelbine has been tested against breast cancer and advanced refractory NSCLC. The combination could have immunostimulatory effects: induction of immunogenic cancer-cell death, enhancement of antigen presentation through dendritic cell modulation, increased cancer-cell immunogenicity, preferential depletion of regulatory T cells, modulation of myeloid-derived suppressor cells, enhancement of the cytotoxic activity of immune-effector cells.

Keywords
immunotherapy, second line of chemotherapy
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.

Study groups in NCT03801304
Study groupRoleWhat they receive
Atezolizumab associated with vinorelbineExperimental* Atezolizumab will be administered with IV infusions. The first one will be a 60-min IV infusion; the subsequent infusions will last 30 minutes when well-tolerated at the dose of 1200 mg on day 1 of each 21-day cycle. * Vinorelbine capsules are taken orally on days 1, 3 and 5 of each week of the 21-day cycle. Vinorelbine will be administered at the dose of 40 mg per day on days 1, 3 and 5 of each week of the 21-day cycle. In case of toxicity, the dose will be decreased to 30 mg.
Receives: Drug: Atezolizumab; Drug: Vinorelbine

What is being measured

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

  1. Occurrence of death or progression of the disease

    To evaluate the occurrence of death or progression of the disease

    Measured: 4 months

Secondary outcomes (5)

  1. Emergence of adverse events (Safety and tolerability)

    To evaluate the safety outcomes, tolerability, adverse events frequency

    Measured: 12 months

  2. Occurrence of death

    To evaluate the occurrence of death over 12 months of follow-up

    Measured: 12 months

  3. Objective Response Rate

    To evaluate the objective Response Rate and Disease Control Rate

    Measured: 4 months

  4. Following of the quality of life

    The scale EuroQol 5 dimensions (EDQ5) is used to evaluate the quality of life. The EQ-5D scale is a standardised measure of health status to provide a simple, generic measure of health for clinical and economic appraisal, whih is divided by the EQ-5D descriptive system (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and the EQ Visual Analogue scale (EQ VAS). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems).

    Measured: 12 months

  5. Following of the quality of life

    The EORTC QLQ-C30 is a questionnaire with 30 questions developed to assess the quality of life of cancer patients. An essential aspect of the "modular" approach to QOL assessment adopted by the EORTC Quality of Life Group is the development of modules specific to tumour site, treatment modality, or a QOL dimension, to be administered in addition to the core questionnaire (EORTC QLQ-C30).

    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 posted11 Jan 2019
  2. Study start24 Jan 2019
  3. Primary completion4 Jan 2021
  4. Study completion23 Feb 2022

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
* Atezolizumab will be administered of 1200 mg on day 1 of each 21-day cycle with IV infusions . * Vinorelbine at the dose of 40 mg per days will be administered on days 1, 3 and 5 of each week of the 21-day cycle.
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03801304
Sponsor's protocol ID
29BRC18-0005 (VinMetAtezo)
Acronym
VinMetAtezo
Status last verified
Jun 2026
First submitted
7 Jan 2019
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected data that underlie results in a publication

Publications

  • Vergnenegre A, Monnet I, Ricordel C, Bizieux A, Curcio H, Bernardi M, Corre R, Guisier F, Hominal S, Le Garff G, Bylicki O, Locher C, Geier M, Chouaid C, Robinet G; GFPC team. Safety and efficacy of second-line metronomic oral vinorelbine-atezolizumab combination in stage IV non-small-cell lung cancer: An open-label phase II trial (VinMetAtezo). Lung Cancer. 2023 Apr;178:191-197. doi: 10.1016/j.lungcan.2023.02.020. Epub 2023 Feb 27.

    PubMed 36868180

  • Vergnenegre A, Monnet I, Bizieux A, Bernardi M, Chiapa AM, Lena H, Chouaid C, Robinet G. Open-label Phase II trial to evaluate safety and efficacy of second-line metronomic oral vinorelbine-atezolizumab combination for stage-IV non-small-cell lung cancer - VinMetAtezo trial, (GFPCdouble dagger 04-2017). Future Oncol. 2020 Feb;16(4):5-10. doi: 10.2217/fon-2019-0730. Epub 2020 Jan 2.

    PubMed 31894704

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab and Vinorelbine in people with Non-small Cell Lung Cancer, run by University Hospital, Brest at 13 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 17 inclusion and 22 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 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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?

Occurrence of death or progression of the disease (time frame: 4 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 NCT03801304, 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 Jun 2026.

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