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New treatment option for NSCLC Stage II
Official title Predicting Response to Neoadjuvant ATEZOLIZUMAB Plus Carboplatin/Nab Paclitaxel in Resectable Non-squamous NSCLC
ClinicalTrials.gov ID: NCT04865250
What this study is testing
What is Atezolizumab 1200 mg abs day 1 q22 (iv)?
Atezolizumab 1200 mg abs day 1 q22 (iv) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nsclc stage ii.
Also referred to as Carboplatin AUC5 day 1 q22 (iv), Nab-Paclitaxel 100 mg/m2 day 1,8,15 q22.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Exploratory study evaluating the potential of immune signature profiling for predicting response in patients with resectable Stage II, IIIA and select IIIB (T3N2 only) non-squamous Non-Small Cell Lung Cancer (NSCLC) to neoadjuvant ATEZOLIZUMAB plus Carboplatin/nab Paclitaxel Atezolizumab is given as intravenous infusion at a fixed dose of 1200 mg, day 1 of each 21-day cycle (every 3 weeks) for 3 cycles during the neoadjuvant treatment phase, Carboplatin at an initial dose of AUC (area under curve) 5 mg/mL/min, intravenously day 1 of each 21-day cycle for 3 cycles during the neoadjuvant treatment Phase, and Nab-Paclitaxel (Abraxane) at 100 mg/m2, intravenously day 1, 8 and 15 of each 21-day cycle for 3 cycles during the neoadjuvant treatment phase. Surgery after the 3rd cycle Atezolizumab / Carboplatin / Nab-Paclitaxel is standard procedure.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Informed consent, patients age ≥ 18-year-old including, signed and dated
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Histologically confirmed NSCLC of non-squamous histology, cStage II, IIIA or select IIIB (T3N2 only); for T-status ≤ T3 allowed; for N2 patients only...
- Deemed surgically resectable with curative intent by an attending thoracic surgeon after adequate staging including PET-CT (positron emission...
- Adequate lung and cardiac function for intended lung resection according to German S3 regulation
You likely can't join if
- Illness or condition that may interfere with a patient's capacity to understand, follow, and/or comply with study procedures
- Treatment in any other clinical trial within 30 days before screening.
- NSCLC Stage cT4
- NSCLC stage cN3 or cN2 IIIA4 (bulky or fixed multi-station N2 disease) according to Robinson classification
- NSCLC of squamous cell histology
- Any prior therapy for lung cancer (including systemic therapy, radiotherapy or major surgery)
See the full eligibility criteria
Who can join
- Informed consent, patients age ≥ 18-year-old including, signed and dated
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Histologically confirmed NSCLC of non-squamous histology, cStage II, IIIA or select IIIB (T3N2 only); for T-status ≤ T3 allowed; for N2 patients only IIIa1-3 Robinson classification allowed
- Deemed surgically resectable with curative intent by an attending thoracic surgeon after adequate staging including PET-CT (positron emission tomography)
- Adequate lung and cardiac function for intended lung resection according to German S3 regulation
- Radiologically measurable disease as defined by response evaluation criteria in solid tumors RECIST v1.1
- Sufficient availability of the tissue sample from primary tumor before start of neoadjuvant treatment
- Females of child-bearing potential must agree to use, and be able to comply with, effective contraception (\</=1% failure rate annually) without interruption, 28 days prior to starting therapy (including dose...
- Females must have a negative serum pregnancy test (β -hCG) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy.
- Male people must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6...
- adequate renal, hepatic, and bone marrow function as defined below
- Absolute neutrophil count (ANC) \> 1500/μl
- Platelet count ≥ 100000/μl
- Hemoglobin ≥ 9 g/dl (can be post-transfusion)
- International normalized ratio (INR) ≤ 1.4 in patients not receiving anticoagulation; for patients receiving respective anticoagulation an INR ≤3.0 allowed
- Activated partial thromboplastin time (aPTT) ≤ 1.5 times upper limit of normal (ULN) in patients not receiving anticoagulation; for patients receiving respective anticoagulation a PTT ≤2.5 ULN allowed
- Bilirubin \< 1.5 times ULN (for patients with known Gilbert disease Bilirubin ≤ 3 times ULN allowed)
- ALT and AST \< 2.5 times ULN
- Creatinine ≤ 1.5 ULN or calculated creatinine clearance \> 60 ml/min for people with creatinine levels \> 1.5 ULN; for patients meeting the criterion of creatinine ≤ 1.5 ULN also a calculated creatinine clearance of \>...
What rules you out
- Illness or condition that may interfere with a patient's capacity to understand, follow, and/or comply with study procedures
- Treatment in any other clinical trial within 30 days before screening.
- NSCLC Stage cT4
- NSCLC stage cN3 or cN2 IIIA4 (bulky or fixed multi-station N2 disease) according to Robinson classification
- NSCLC of squamous cell histology
- Any prior therapy for lung cancer (including systemic therapy, radiotherapy or major surgery)
- Malignancies other than NSCLC within 5 years prior to study inclusion with the exception of malignancies with a negligible risk of metastasis or death (5-year OS \> 90%) like localized prostate cancer, ductal carcinoma...
- History of allogeneic tissue / solid organ transplant or allogeneic stem cell transplantation
- Patients with active hepatitis B or C infections or a history of HIV infection
- Pregnant or lactating women
- Active autoimmune disease or history of severe autoimmune disease or immunodeficiency or a syndrome that requires systemic steroids or immunosuppressive agents
- The following exceptions are granted:
- patients with vitiligo, eczema, lichen simplex or resolved childhood asthma/atopy
- people requiring intermittent use of bronchodilatators or local steroid injections
- patients with hypothyroidism stable on hormone replacement
- Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, and anti-tumor necrosis factor (anti-TNF) agents) within 2 weeks prior to...
- History of idiopathic pulmonary fibrosis, interstitial lung disease, organizing pneumonia, drug-induced pneumonitis, or evidence of active pneumonitis on screening chest Computed Tomography (CT) scan
- Prior treatment with cluster of differentiation 137 (CD137) agonist or immune checkpoint blockade therapies, anti-programmed-death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibody
- Live vaccine within 30 days prior to first dose of trial treatment
- Cerebrovascular accident within the past 6 months
- Severe infection or significant traumatic injury within the past 4 weeks
- Clinically significant history of cardiovascular disease, including any of the following:
- Myocardial infarction or unstable angina within the past 6 months
- New York Heart Association class II, III-IV congestive heart failure
- Poorly controlled cardiac arrhythmia despite medication, except rate-controlled atrial fibrillation
- Known allergy or hypersensitivity to any component of the chemotherapy regimen Patients who have been incarcerated or involuntarily institutionalized by court order or by the authorities, as well as patients who are...
The study team makes the final eligibility decision.
Where it's taking place
- Heidelberg, BaWü, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Heidelberg, BaWü, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.