Predicting Response to Neoadjuvant ATEZOLIZUMAB Plus Carboplatin/Nab Paclitaxel in Resectable Non-squamous NSCLC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Heidelberg
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Atezolizumab 1200 mg abs day 1 q22 (iv)
DrugImmune checkpoint blockade antibody ATEZOLIZUMAB directed against PD-L1 (Programmed death-ligand 1); Carboplatin; Nab-Paclitaxel (iv)
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Response to neoadjuvant immunochemotherapy with ATEZOLIZUMAB, Carboplatin and nab-Paclitaxel
determined by Major Pathologic Response (MPR) (≤10% residual viable tumor cells) (pathologic regression grading according to Junker criteria) rate
Time frame
up to 5 months (after 9 weeks of neoadjuvant immunochemotherapy (3 cycles with 21 days per cycle) + surgery (4-8 additional weeks after completion of neoadjuvant immunochemotherapy)Secondary outcomes
1
Response rate according to RECIST 1.1 criteria
determined by Δ tumor size and Δ lymph node size
Time frame
pre-surgery after completion of neoadjuvant immunochemotherapy2
Response rate as determined by Δ PETactivity
determined by standardized uptake value \[SUV\] (standard uptake value)
Time frame
pre-surgery after completion of neoadjuvant immunochemotherapy3
Event-free survival (EFS)
time to any of the following events, whichever occurs first: progression of disease prior to surgery as defined by RECIST v1.1, local or distant disease recurrence, or death due to any cause
Time frame
up to 29 months after study inclusion; calculated from start of 1st cycle of neoadjuvant treatment, thus including three 21 day cycles+surgery, follow-up for 24 months after end of treatment visit; end of treatment visit takes place 6 weeks after surgery4
Overall survival (OS)
time to death due to any cause
Time frame
up to 29 months after study inclusion; calculated from start of 1st cycle of neoadjuvant treatment, thus including three 21 day cycles+surgery, follow-up for 24 months after end of treatment visit; end of treatment visit takes place 6 weeks after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Heidelberg
Lead sponsor
Dietmar Hopp Stiftung
Collaborator
Source ClinicalTrials.gov