Actively Recruiting
Predicting Response to Neoadjuvant ATEZOLIZUMAB Plus Carboplatin/Nab Paclitaxel in Resectable Non-squamous NSCLC
Led by University Hospital Heidelberg · Updated on 2024-05-16
20
Participants Needed
1
Research Sites
311 weeks
Total Duration
On this page
Sponsors
U
University Hospital Heidelberg
Lead Sponsor
D
Dietmar Hopp Stiftung
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Predicting Response to Neoadjuvant ATEZOLIZUMAB Plus Carboplatin/Nab Paclitaxel in Resectable Non-squamous NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and age 18 years or older
- ECOG performance status 0 or 1
- Histologically confirmed non-squamous NSCLC at clinical Stage II, IIIA, or select IIIB (T3N2 only)
- Tumor deemed surgically resectable with curative intent after PET-CT staging
- Adequate lung and heart function for lung surgery
- Measurable disease per RECIST v1.1 criteria
- Sufficient tissue sample from primary tumor before neoadjuvant treatment
- Females of child-bearing potential agree to use effective contraception and have negative pregnancy tests
- Males agree to abstinence or use condoms with females of child-bearing potential during and after treatment
- Adequate kidney, liver, and bone marrow function as defined by blood count and chemistry thresholds
You will not qualify if you...
- Any illness that interferes with understanding or following study procedures
- Participation in another clinical trial within 30 days before screening
- NSCLC Stage cT4 or bulky/fixed multi-station N2 disease
- Squamous cell histology of NSCLC
- Previous lung cancer treatment including systemic therapy, radiotherapy, or major surgery
- Other malignancies within 5 years except low-risk cancers
- History of allogeneic tissue or stem cell transplant
- Active hepatitis B or C or history of HIV infection
- Pregnant or breastfeeding women
- Active or severe autoimmune disease requiring systemic steroids or immunosuppressants
- Recent use of systemic immunosuppressive drugs within 2 weeks before cycle 1 day 1
- History or evidence of lung diseases like pulmonary fibrosis or active pneumonitis
- Previous treatment with CD137 agonists or immune checkpoint inhibitors
- Live vaccine within 30 days before first study dose
- Recent stroke, severe infection, or major injury
- Significant cardiovascular diseases including recent myocardial infarction, unstable angina, advanced heart failure, or uncontrolled arrhythmia
- Allergy to any chemotherapy components
- Incarceration or inability to consent due to understanding issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Thoraxklinik Heidelberg gGmbH
Heidelberg, BaWü, Germany, 69126
Actively Recruiting
Research Team
D
Dirk Jäger, Prof. med.
CONTACT
M
Martin Eichhorn, PD Dr. med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here