OncoMatch/Clinical Trials/NCT04865250
Predicting Response to Neoadjuvant ATEZOLIZUMAB Plus Carboplatin/Nab Paclitaxel in Resectable Non-squamous NSCLC
Is NCT04865250 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
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.
Frequently asked questions
Is NCT04865250 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage CSTAGE II or CSTAGE IIIA or SELECT IIIB (T3N2 ONLY) is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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