RecruitingNCT06310915

Oral Chemotherapeutic Drugs Were Analyzed in Patients With Driver Gene Negative Locally Advanced/Advanced Non-small Cell Lung Cancer With PS Score 2 A Prospective, Single-arm, Multicenter, Observational Study on the Efficacy and Safety of Radiochemotherapy Combined With PD-1 Inhibitor

This Study is a Pilot Study in Driver-negative Locally Advanced/Late-stage Nonsmall Cell Lung Cancer With ECOG PS=2 Analysing the Efficacy, Safety and Efficacy of Oral Chemotherapy in Combination With PD-1 Inhibitors and Safety of Oral Chemotherapy in Combination With PD-1 Inhibitors in Patients With Locally Advanced/Advanced Non-cellular Lung Cancer withECOG PS=2.This is a Prospective, Single-arm, Multicentre, Observational Study


Sponsor

Guangzhou Institute of Respiratory Disease

Enrollment

30 participants

Start Date

Mar 17, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

Oral chemotherapeutic drugs were analyzed in patients with driver gene negative locally advanced/advanced non-small cell lung cancer with PS score 2 A prospective, single-arm, multicenter, observational study on the efficacy and safety of radiochemotherapy combined with PD-1 inhibitor.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This observational study looks at how well a combination of oral chemotherapy, radiation therapy, and a PD-1 inhibitor (an immunotherapy drug) works in patients with advanced non-small cell lung cancer (NSCLC) who have a poor performance status (PS score 2), meaning they have significant limitations in daily activities, and whose tumors do not have the typical gene mutations that respond to targeted therapies. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with advanced non-small cell lung cancer (stage IIIB or IV, or recurring/progressing disease) - Your tumor does NOT have EGFR, ALK, or ROS1 gene mutations - You have significant physical limitations due to your illness (performance status score of 2) - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - You have received prior systemic chemotherapy for advanced disease (with some exceptions for early-stage prior treatment) - You have uncontrolled brain metastases - You have serious heart, liver, or autoimmune conditions - You are pregnant or breastfeeding 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

DRUGNavelbine oral,Pembrolizumab

Oral vinorelbine was administered three times weekly, and pembrolizumab was administered every 3 weeks


Locations(1)

The First Affiliated Hospital of Guangzhou Medical University

Guangdong, Guangzhou, China

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NCT06310915


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