Predicting Response to Neoadjuvant ATEZOLIZUMAB Plus Carboplatin/Nab Paclitaxel in Resecta
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 infusio
| Condition(s) | NSCLC Stage II, NSCLC, Stage IIIA, NSCLC Stage IIIB |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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 / |
| Who can participate | Inclusion Criteria: * 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) * Adequate lung and cardiac function for intended lung resection according to German S3 regulation * Radiologically measurable disease as defined by response evaluation criteria in solid tumors RECIST v1.1 * Sufficient availability of the tissue sample from primary tumor before start of |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University Hospital Heidelberg |
| Locations | Heidelberg, BaWü, Germany |
| Start date | 2021-01-07 |
| NCT ID | NCT04865250 |
| Official listing | https://clinicaltrials.gov/study/NCT04865250 |