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 (IReP)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516590-75-00

Acronym

IReP

Enrollment

Registered

2024-09-18

Start date

2021-02-22

Completion date

Unknown

Last updated

2024-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer

Brief summary

Response to neoadjuvant immunochemotherapy with ATEZOLIZUMAB, Carboplatin and nab- Paclitaxel as determined by Major Pathologic Response (MPR) (≤10% residual viable tumor cells) (pathologic regression grading according to Junker criteria) rate

Detailed description

Response rate as determined by Δ tumor size and Δ lymph node size according to RECIST 1.1 criteria, Response rate as determined by Δ PETactivity (standardized uptake value [SUV]), Event-free survival (EFS) ● calculated from start of 1st cycle of neoadjuvant treatment ● follow-up for 24 months after end of treatment visit; end of treatment visit takes place 6 weeks after surgery, Overall survival (OS) ● calculated from start of 1st cycle of neoadjuvant treatment ● follow-up for 24 months after end of treatment visit; end of treatment visit takes place 2-6 weeks after surgery, Number of patients attaining surgery as planned

Interventions

DRUGAbraxane 5 mg/ml powder for dispersion for infusion.

DRUGCarboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGTecentriq 1 200 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Response to neoadjuvant immunochemotherapy with ATEZOLIZUMAB, Carboplatin and nab- Paclitaxel as determined by Major Pathologic Response (MPR) (≤10% residual viable tumor cells) (pathologic regression grading according to Junker criteria) rate	—

Secondary

Measure	Time frame
Response rate as determined by Δ tumor size and Δ lymph node size according to RECIST 1.1 criteria, Response rate as determined by Δ PETactivity (standardized uptake value [SUV]), Event-free survival (EFS) ● calculated from start of 1st cycle of neoadjuvant treatment ● follow-up for 24 months after end of treatment visit; end of treatment visit takes place 6 weeks after surgery, Overall survival (OS) ● calculated from start of 1st cycle of neoadjuvant treatment ● follow-up for 24 months after end of treatment visit; end of treatment visit takes place 2-6 weeks after surgery, Number of patients attaining surgery as planned	—

Measure

Time frame

—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026