RecruitingPhase 2NCT04865250

Predicting Response to Neoadjuvant ATEZOLIZUMAB Plus Carboplatin/Nab Paclitaxel in Resectable Non-squamous NSCLC

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


Sponsor

University Hospital Heidelberg

Enrollment

20 participants

Start Date

Jan 7, 2021

Study Type

INTERVENTIONAL

Conditions

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 / Carboplatin / Nab-Paclitaxel is standard procedure.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding atezolizumab (an immunotherapy drug) to standard chemotherapy (carboplatin + nab-paclitaxel) before surgery in people with non-squamous non-small cell lung cancer (NSCLC) improves outcomes, while also looking for biological markers that predict who responds best. **You may be eligible if...** - You are 18 years or older - You have non-squamous NSCLC (not squamous cell type) at stage II, IIIA, or selected IIIB - Your cancer has been deemed surgically removable with curative intent by a thoracic surgeon - You are in good general health (ECOG 0–1) **You may NOT be eligible if...** - Your cancer is squamous cell carcinoma - Your cancer is not surgically removable - Your health status is too poor to receive chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtezolizumab 1200 mg abs day 1 q22 (iv)

Immune checkpoint blockade antibody ATEZOLIZUMAB directed against PD-L1 (Programmed death-ligand 1); Carboplatin; Nab-Paclitaxel (iv)


Locations(1)

Thoraxklinik Heidelberg gGmbH

Heidelberg, BaWü, Germany

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NCT04865250


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