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Nonsmall Cell Lung CancerPhase 2PRINCEPSNCT02994576

Atezolizumab as Induction Therapy in Non-small Cell Lung Cancer

A Phase 2 study testing Atezolizumab in people with Nonsmall Cell Lung Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 3 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

Based on the efficacy of immunotherapies in advanced disease with a reasonable safety profile/tolerability we could hypothesize that, immunotherapy should work best in the situation of minimal residual disease, Two clinical trials are ongoing to test the role of immunotherapeutic agents in the adjuvant setting: PEARLS… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nonsmall Cell Lung Cancer
What is being tested?
Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesFrance
Study dates
12 Dec 2016to Mar 2023
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

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Centre Hospitalier de Chauny

    Chauny

  • Centre Marie Lannelongue

    Le Plessis-Robinson

  • Gustave Roussy

    Villejuif, Val de Marne, 94805

Other trials in France

About this study

Official title: A Single-arm Phase 2 Study of Atezolizumab as Induction Therapy in Stage IB-IIIA Non N2 Resectable and Untreated Non-small Cell Lung Cancer (NSCLC)

Based on the efficacy of immunotherapies in advanced disease with a reasonable safety profile/tolerability we could hypothesize that, immunotherapy should work best in the situation of minimal residual disease, Two clinical trials are ongoing to test the role of immunotherapeutic agents in the adjuvant setting: PEARLS trial, a randomized phase III trial with anti-PD1 monoclonal antibody pembrolizumab (MK-3475 or pembrolizumab) versus placebo for patients with early stage NSCLC after resection and completion of standard adjuvant therapy, and the second randomized phase III trial (NCT02273375) will evaluate the efficacy of an anti-PD-L1 (MEDI 4736) for a maximum of 12 months versus placebo as adjuvant therapy in completed resected stage IB-IIIA NSCLC and completed standard ACT.

The role of immunotherapeutic approaches for NSCLC in the neoadjuvant setting is currently unknown. However, based on the survival efficacy of immunotherapeutic strategies in advanced NSCLC where the tumor has not been removed which could produce higher immunogenicity and based on the efficacy of neoadjuvant treatments in NSCLC, we propose to test the safety and efficacy of atezolizumab as neoadjuvant therapy in subjects diagnosed with stage I, II, or IIIA (non N2) NSCLC and who are deemed suitable for surgical resection.

Clinical staging of NSCLC is based on computed tomography (CT) of the chest and upper abdomen, brain CT or magnetic resonance imaging and 18F-FDG PETscan to rule out metastatic disease and assess the potential for curative-intent resection. Adjuvant chemotherapy will be performed according the standard clinical guidelines.

Being tested
Atezolizumab
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.

  • AtezolizumabDrug

    Atezolizumab, 1200 mg administered I.V. once

Study groups in NCT02994576
Study groupRoleWhat they receive
Stage IB(≥ 2 cm)-IIIA non N2, resectable and untreated NSCLCExperimentalNot described
Receives: Drug: Atezolizumab
Comparative cohort (patients receiving standard treatment)No interventionNot described

What is being measured

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

  1. The rate of patients without major toxicities or morbidities

    Major toxicities or morbidities: it will include

    1. treatment toxicity leading to a delay of at least 15 days of the surgery, b) grade ≥ 3 toxicity occurring within 2 months after atezolizumab infusion, c) major postoperative morbidity and d) any death related to the experimental treatment and occurring in the period from the day of injection of atezolizumab to the 30 postoperative days. Patients that did not have surgery because of early progression will be considered as having major toxicities or morbidities.

    Measured: During the period defined as the start of treatment and 1 month after the surgery (2-month tolerance rate)

Timeline

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

  1. First posted16 Dec 2016 (estimated)
  2. Study start12 Dec 2016
  3. Primary completionMar 2023
  4. Study completionMar 2023

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02994576
Sponsor's protocol ID
2016-000270-38
Other IDs
2016/2362, 2016
Acronym
PRINCEPS
Status last verified
Aug 2026
First submitted
13 Dec 2016
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Besse B, Adam J, Cozic N, et al. 1215O-SC Neoadjuvant atezolizumab (A) for resectable non-small cell lung cancer (NSCLC): results from the phase II PRINCEPS trial. Ann Oncol. 2020;31:S794-S795. doi:10.1016/j.annonc.2020.08.1417

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab in people with Nonsmall Cell Lung Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 3 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 29 inclusion and 39 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 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

The rate of patients without major toxicities or morbidities (time frame: During the period defined as the start of treatment and 1 month after the surgery (2-month tolerance rate)). 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 NCT02994576, which also lists 1 linked publication.

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 17 Aug 2026.

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