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Can an immune booster before surgery beat lung cancer?

NCT ID NCT02994576

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This trial is testing whether giving the immunotherapy drug atezolizumab before surgery can help people with early-stage non-small cell lung cancer. The study includes adults with stage IB to IIIA (non-N2) disease who are eligible for surgery. Participants receive one dose of atezolizumab, then undergo surgery, and the trial tracks safety and how well the treatment works.

What this could mean

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

Active substance
atezolizumab (an immunotherapy drug given by IV infusion before surgery)
What this could lead to
If it works, giving atezolizumab before surgery could shrink tumors and improve outcomes for people with early-stage lung cancer, potentially leading to a new treatment approach.
What could go wrong
This is a small, early-phase study, so results may not be conclusive. The drug can cause immune-related side effects, and surgery delays or complications are possible.

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2016

Finished

Mar 2023

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: Inclusion criteria for the principal study: * Age ≥ 18 years * Histologically documented NSCLC * Clinical Stage IA (≥ 2 cm)-IIIA non N2 NSCLC eligible for surgical resection * Initial work-up including pet scan and MRI for staging * Measurable disease, as defined by RECIST v1.1. * Apt to surgical resection by a lobectomy or bilobectomy procedure * ECOG performance status of 0 or 1 (appendix 3) * Adequate hematologic and organ function, defined by the following laboratory results obtained within 14 days prior to registration: * White blood cell (WBC) counts \> 2.5 x 10\^9/L * Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (without granulocyte colony-stimulating factor support within 2 weeks prior to Day 1) * Platelet count ≥100 x 10\^9/L * Hemoglobin ≥ 9.0 g/dL. Patients may be transfused to meet this criterion. * AST, ALT, and alkaline phosphatase ≤ 2.5 X the upper limit of normal (ULN), * Serum bilirubin ≤ 1.5 X ULN. Patients with known Gilbert disease who have serum bilirubin level ≤ 3 X ULN may be enrolled. * International Normalized Ratio (INR) and activated Partial Thromboplastin Time (aPTT) ≤ 1.5 X ULN -This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose. * Creatinine clearance ≥ 60 mL/min on the basis of the Modification of Diet in Renal Disease (MDRD) * Serum albumin ≥2.5 g/dL * Calcemia ≤ 2.65 mmol/L or Ca ≤10 mg/dL * Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 14 days before the registration and must be willing to use two methods of contraception, one of them being a barrier method, or to abstain from sexual activity during the study and for 5 months after last study drug administration. Sexually active males and their female partners must agree to use two methods of accepted and effective contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study. * Information delivered to the patient and informed consent form signed by the patient * Ability to comply with the protocol procedures * Patient affiliated to a social security system or beneficiary of the same Inclusion criteria for patients included in the comparative cohort (patients receiving standard treatment): * Age ≥ 18 years * NSCLC * Clinical Stage IA (≥2 cm)-IIIA eligible for surgical resection (per the Union Internationale contre le Cancer/American Joint Committee on Cancer staging system, 7th edition; Detterbeck et al. 2009) * Information delivered to the patient and informed consent form signed by the patient * Ability to comply with the protocol procedures * Patient affiliated to a social security system or beneficiary of the same Exclusion Criteria: Non-inclusion criteria for the principal study: Patients who meet any of the following criteria will be excluded from study entry: * History of prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma for at least five years before registration. * Prior therapy for lung cancer * Pregnant and breast feeding women * History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins * Known hypersensitivity to Chinese hamster ovary (CHO) cell products or any component of the atezolizumab product * 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, Type I diabetes mellitus, vasculitis, or glomerulonephritis (see Appendix 5 for a more comprehensive list of autoimmune diseases). Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study. * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan * History of HIV infection * Patients with active hepatitis B (chronic or acute) or hepatitis C Patients with past/resolved HBV infection (defined as the presence of anti-hepatitis B core antibody, IgG anti-HBs + and absence of HbsAg) are eligible. HBV DNA should be obtained in these patients prior to Day 1. Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA. * Active tuberculosis * Severe infections within 4 weeks prior to registration, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia * Signs or symptoms of infection within 2 weeks prior to registration * Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina * Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction \<50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate. * Major surgical procedure other than for diagnosis within 28 days prior to registration or anticipation of need for a major surgical procedure during the course of the study * Prior allogeneic stem cell or solid organ transplant * History of any hematological disease not considered in complete remission for at least five years before registration. * Administration of a live, attenuated vaccine within 4 weeks before registration or anticipation that such a live attenuated vaccine will be required during the study or for 5 months after study drug administration. Influenza vaccination should be given during influenza season only (approximately October to March). Patients must not receive live, attenuated influenza vaccine (e.g., FluMistâ) within 4 weeks prior to registration or at any time during the study. * Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications * Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA4, anti-PD-1, and anti-PD-L1 therapeutic antibodies * Treatment with systemic immunostimulatory agents (including but not limited to interferons, interleukin-2) within 6 weeks or five half-lives of the drug, whichever is shorter, prior registration * Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 2 weeks prior to registration * Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled in the study after discussion with and approval by the coordinating investigator. The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed. Non-inclusion criteria for the comparative cohort (patients receiving standard treatment): * Prior therapy for lung cancer * Pregnant and breast feeding women * Active tuberculosis * Severe infections within 4 weeks prior to registration, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia * Signs or symptoms of infection within 2 weeks prior to registration * Prior allogeneic stem cell or solid organ transplant * History of any hematological disease not considered in complete remission for at least five years before registration. * Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA4, anti-PD-1, and anti-PD-L1 therapeutic antibodies. * Treatment with systemic immunostimulatory agents (including but not limited to interferons, interleukin-2) within 6 weeks or five half-lives of the drug, whichever is shorter, prior registration * Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 2 weeks prior to registration * Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled in the study after discussion with and approval by the principal investigator. The use of inhaled

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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

  • Centre Hospitalier de Chauny

    Chauny, France

  • Centre Marie Lannelongue

    Le Plessis-Robinson, France

  • Gustave Roussy

    Villejuif, Val de Marne, 94805, France

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