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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06310915

Enrollment

Registered

2024-03-15

Start date

2023-03-17

Completion date

2025-05-31

Last updated

2024-03-15

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

Conditions

Non-small Cell Lung Cancer Stage IIIB/IV

Keywords

Advanced non-small cell lung cancer

Brief 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.

Interventions

DRUGNavelbine oral,Pembrolizumab

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 1\. Age of 18-80 years old, both sexes; * 2\. Patients with histologically confirmed advanced non-small cell lung cancer with stage IIIB /IV disease (according to the International Association for the Study of Lung Cancer Staging Manual for Thoracic Tumors, 8th edition) or disease recurrence or progression after multimodal treatment (radiotherapy, surgical resection, or definitive chemoradiotherapy for locally advanced disease); * 3\. Patients should have no EGFR gene sensitive mutations (including but not limited to exon 19 deletion, exon 21 L858R mutation, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutation), ALK gene rearrangement, or ROS1;

Exclusion criteria

* 4.Participants had to have measurable lesions on CT or MRI according to RECIST 1.1 (tumor imaging was performed within 28 days before the first dose of study drug) or clinically significant lesions that could be followed for response according to RECIST 1.1 by the investigator; * 5\. No prior systemic therapy (patients with prior platinum-based adjuvant chemotherapy, neoadjuvant chemotherapy, or definitive chemoradiotherapy for advanced disease could enter if disease progression occurred \>6 months after the last treatment); * 6\. Ecog ps =2分; * 7\. Estimated survival time \> 12 weeks;

Design outcomes

Primary

Measure	Time frame	Description
Progression-free survival time	2 year	The time from the date of randomization to the date of first documented disease progression, assessed up to 2 years.

Countries

China

Contacts

Primary Contactzhou chengzhi, doctor

doctorzcz@163.com13560351186

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026