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Old chemo drug gets new partner in fight against lung cancer

NCT ID NCT03801304

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This phase II trial tests whether a low-dose, frequent schedule of the chemotherapy drug vinorelbine, taken orally, can boost the effects of the immunotherapy atezolizumab in people with stage IV non-small cell lung cancer. The study enrolls adults whose cancer has progressed after initial treatment and who do not have certain genetic mutations. The goal is to see if this combination can delay disease progression or death better than current second-line options.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vinorelbine and atezolizumab
What this could lead to
If successful, this combination could offer a new second-line treatment option for advanced lung cancer patients who have limited choices.
What could go wrong
This is an early-phase trial with only 80 participants, so results may not apply broadly. The combination may cause side effects or fail to improve survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

80 people

The number who actually took part.

Started

Jan 2019

Finished

Feb 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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; * 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 Exclusion Criteria: * 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; * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • CH Aix en Provence

    Aix-en-Provence, France, France

  • CH MEAUX

    Meaux, France, France

  • CH Pringy

    Pringy, France, France

  • CH Quimper

    Quimper, France, France

  • CH Saint-Brieuc

    Saint-Brieuc, France, France

  • CH de Créteil

    Créteil, France, 94010, France

  • CHRU de Brest - Hôpital Morvan

    Brest, France, 29609, France

  • CHU Rouen

    Rouen, France, France

  • CHU de Limoges - Hôpital DUPUYTREN

    Limoges, France, 87042, France

  • CHU de Rennes

    Rennes, France, 35033, France

  • CLCC Caen

    Caen, France, France

  • Ch La Roche Sur Yon

    La Roche-sur-Yon, France, 85000, France

  • Hia Saint Anne

    Toulon, France, 83041, France

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