RecruitingPhase 2NCT06424899

A Study Comparing Neoadjuvant Chemoimmunotherapy and Immuno-consolidationafter Compared With Immunoconsolidation After Radical Chemoradiotherapy for Stage III Potentially Resectable NSCLC

A Randomized, Controlled, Multicenter Phase II Clinical Study Comparing Neoadjuvant Chemoimmunotherapy and Immuno-consolidationafter Compared With Immunoconsolidation After Radical Chemoradiotherapy for Stage III Potentially Resectable NSCLC


Sponsor

Zeng Jian

Enrollment

92 participants

Start Date

May 19, 2024

Study Type

INTERVENTIONAL

Summary

To evaluate the efficacy and safety adebrelimab in Combination with chemotherapy after 3 cycles as neoadjuvant therapy and surgery or chemoradiotherapy based on MDT compared with adebrelimab after chemoradiotherapy in potentially operable stage III NSCLC.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment strategies for Stage III non-small cell lung cancer (NSCLC) that may be surgically removable: one group receives chemoimmunotherapy before and after surgery, while the other receives chemoradiotherapy followed by immunotherapy. The goal is to see which approach leads to better outcomes. **You may be eligible if...** - You are between 18 and 75 years old - You have Stage IIIA or IIIB NSCLC confirmed by biopsy - Your cancer is deemed potentially removable by a multidisciplinary team - You have not had any prior cancer treatment for lung cancer - Your lung function is adequate (FEV1 and DLCO ≥ 50% predicted) - You have no EGFR or ALK mutations (if adenocarcinoma) **You may NOT be eligible if...** - You have had surgery, chemotherapy, radiation, or immunotherapy for lung cancer before - You have had another type of cancer previously - Your heart or lung function is significantly impaired - Your cancer is not potentially resectable after review 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAdebrelimab

This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 20mg/kg, administered every 3 Weeks (Q3W).

RADIATIONradical chemoradiotherapy

The total dose of radiotherapy was 60 Gy ± 10% (54 Gy - 66 Gy). The minimum technical standard for radiotherapy is the three dimensional conformal radiotherapy (3D-CRT) planned by CT.

DRUGPlatinum based chemotherapy

Platinum based chemotherapy: Platinum drug must be one of cisplatin, carboplatin or nedaplatin; The other drug must contain one of the following: etoposide, vinorelbine, vinblastine, pemetrexed, taxanes (e.g., paclitaxel, docetaxel, albumin paclitaxel, paclitaxel liposomes) or gemcitabine (gemcitabine is not permitted in concurrent chemoradiotherapy regimens).


Locations(1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06424899