OncoMatch/Clinical Trials/NCT04865250
Predicting Response to Neoadjuvant ATEZOLIZUMAB Plus Carboplatin/Nab Paclitaxel in Resectable Non-squamous NSCLC
Is NCT04865250 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Atezolizumab 1200 mg abs day 1 q22 (iv) for nsclc stage ii.
Treatment: Atezolizumab 1200 mg abs day 1 q22 (iv) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Disease stage
Required: Stage CSTAGE II, CSTAGE IIIA, SELECT IIIB (T3N2 ONLY) (clinical)
Excluded: Stage CN3, CN2 IIIA4 (BULKY OR FIXED MULTI-STATION N2 DISEASE)
cStage II, IIIA or select IIIB (T3N2 only); for T-status ≤ T3 allowed; for N2 patients only IIIa1-3 Robinson classification allowed
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: any therapy for lung cancer
Any prior therapy for lung cancer (including systemic therapy, radiotherapy or major surgery)
Lab requirements
Blood counts
ANC > 1500/μl; Platelet count ≥ 100000/μl; Hemoglobin ≥ 9 g/dl (can be post-transfusion); INR ≤ 1.4 (≤ 3.0 if on anticoagulation); aPTT ≤ 1.5x ULN (≤ 2.5x ULN if on anticoagulation)
Kidney function
Creatinine ≤ 1.5x ULN or calculated creatinine clearance > 60 ml/min for subjects with creatinine > 1.5x ULN; for patients with creatinine ≤ 1.5x ULN, calculated creatinine clearance > 30 ml/min is mandatory
Liver function
Bilirubin < 1.5x ULN (≤ 3x ULN for Gilbert disease); ALT and AST < 2.5x ULN
Cardiac function
Adequate cardiac function for intended lung resection according to German S3 regulation
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 subjects with creatinine levels > 1.5 ULN; for patients meeting the criterion of creatinine ≤ 1.5 ULN also a calculated creatinine clearance of > 30 ml/min is mandatory
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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