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Phase 2
Age: 18Years +
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ID04865250

Study of Immune Profiling to Predict Response to Neoadjuvant Atezolizumab with Carboplatin and Nab-Paclitaxel in Resectable Non-Squamous NSCLC Stages II to Select IIIB

Led by University Hospital Heidelberg · Updated on 2024-05-16

20

Participants Needed

1

Research Sites

108 weeks

Total Duration

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 mgm2 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

Research Team

D

Dirk Jäger, Prof. med.

M

Martin Eichhorn, PD Dr. med.

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