Health Trials

About this trial

This study is an open-label, multicenter, single-arm clinical study.

Eligibility criteria

Qualifiers

Patients with histologically or cytologically confirmed, previously untreated EGFR-mutant (19del/L858R) locally advanced or metastatic (stage IIIB/IIIC or IV) non-small cell lung cancer (NSCLC), according to the 9th edition of the TNM staging system for lung cancer jointly issued by the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC);

Male or female patients aged ≥ 18 years;

Patients who are willing to receive third-generation EGFR-TKI targeted therapy, followed by maintenance therapy with a PD-1 antibody during the stable phase of the disease (defined as no further tumor shrinkage for at least two consecutive assessments based on RECIST v1.1 criteria);

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

Disqualifiers

Patients who are ineligible for standard anti-tumor therapy according to routine clinical practice;

Prior treatment with anti-PD-1/PD-L1 immunotherapy;

Concurrent enrollment in another clinical study;

Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;

Trial design

Treatments tested in this trial

  • EGFR-TKIs Combined with PD-1 Monoclonal Antibody

Treatment groups

32 Participants
are divided into 1 treatment group

Locations

1
Southern Medical University Nanfang Hospital Department of Oncology GuangzhouGuangdong, China

Sponsors and collaborators

Nanfang Hospital, Southern Medical University

Lead sponsor

Source ClinicalTrials.gov