Actively Recruiting
Exploratory Study Evaluating Immune Signature Profiling to Predict 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
108 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
Researchers are exploring a new treatment approach for patients with resectable non-squamous non-small cell lung cancer (NSCLC) at stages II, IIIA, and select IIIB (T3N2 only). This study aims to evaluate the potential of immune signature profiling to predict how patients respond to a combination of neoadjuvant immunochemotherapy involving atezolizumab, carboplatin, and nab-paclitaxel. The study is conducted in a Phase 2 setting and focuses on improving outcomes through better understanding of treatment response before surgery. The treatment involves three cycles of intravenous infusions every 21 days: atezolizumab at a fixed dose of 1200 mg on day 1, carboplatin at an initial dose of AUC 5 on day 1, and nab-paclitaxel at 100 mg/m2 on days 1, 8, and 15. After these three cycles of neoadjuvant therapy, patients undergo standard surgical removal of the tumor, which includes lobectomy or bi-lobectomy with systematic lymph node dissection. Participants will be closely monitored through various assessments including imaging scans to measure tumor response, surgical evaluation, and molecular and immunological biomarker analyses to predict treatment outcomes. Researchers will track major pathologic response rates, event-free survival, overall survival, and safety over a period that extends up to 29 months from the start of treatment. The study includes detailed laboratory tests and clinical evaluations to ensure patient safety and treatment adherence throughout the study duration.
CONDITIONS
Brief 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 staging including PET-CT
- Adequate lung and cardiac function for lung surgery
- Radiologically measurable disease per RECIST v1.1
- Sufficient tumor tissue sample available before neoadjuvant treatment
- Females of childbearing potential must use effective contraception before and during study and for 120 days after last dose
- Negative pregnancy test at screening and agreement to ongoing pregnancy testing
- Males must practice abstinence or use condoms during study and for 6 months after treatment
- Adequate renal, hepatic, and bone marrow function with specified laboratory values
You will not qualify if you...
- Illness or condition affecting ability to understand or comply with study procedures
- Participation in another clinical trial within 30 days before screening
- NSCLC stage cT4 or cN3, or bulky/fixed multi-station N2 disease
- Squamous cell NSCLC histology
- Prior lung cancer treatment including systemic therapy, radiotherapy, or major surgery
- Other malignancies within 5 years except those with negligible metastasis risk
- 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 or immunodeficiency requiring systemic steroids or immunosuppressants
- Recent systemic immunosuppressive treatment within 2 weeks before study
- History or evidence of pulmonary fibrosis, interstitial lung disease, or pneumonitis
- Prior treatment with immune checkpoint inhibitors or CD137 agonists
- Live vaccine within 30 days before first study dose
- Recent cerebrovascular accident or severe infection
- Significant cardiovascular disease including recent heart attack or unstable angina
- Known allergy to chemotherapy components
- Incarceration, involuntary institutionalization, or inability to consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 9 weeks
Participants receive three 21-day cycles of neoadjuvant immunochemotherapy with atezolizumab, carboplatin, and nab-paclitaxel before surgery.
3 cycles with multiple visits during each 21-day cycle
Duration - 4 to 8 weeks after treatment
Participants undergo standard lobectomy or bi-lobectomy with systematic lymph node dissection.
1 surgical procedure with follow-up care
Duration - Up to 24 months after surgery
Participants are followed for event-free and overall survival outcomes and safety monitoring after surgery and treatment completion.
Regular follow-up visits over 24 months
Trial Site Locations
Total: 1 location
1
Thoraxklinik Heidelberg gGmbH
Heidelberg, BaWü, Germany, 69126
Actively Recruiting
Research Team
D
Dirk Jäger, Prof. med.
M
Martin Eichhorn, PD Dr. med.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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