Old chemo drug gets new partner in fight against lung cancer
NCT ID NCT03801304
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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80 people
The number who actually took part.
- Started
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Jan 2019
- Finished
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Feb 2022
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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CH Aix en Provence
Aix-en-Provence, France, France
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CH MEAUX
Meaux, France, France
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CH Pringy
Pringy, France, France
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CH Quimper
Quimper, France, France
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CH Saint-Brieuc
Saint-Brieuc, France, France
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CH de Créteil
Créteil, France, 94010, France
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CHRU de Brest - Hôpital Morvan
Brest, France, 29609, France
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CHU Rouen
Rouen, France, France
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CHU de Limoges - Hôpital DUPUYTREN
Limoges, France, 87042, France
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CHU de Rennes
Rennes, France, 35033, France
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CLCC Caen
Caen, France, France
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Ch La Roche Sur Yon
La Roche-sur-Yon, France, 85000, France
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Hia Saint Anne
Toulon, France, 83041, France
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