A Prospective Multicenter Study of the Association Betwee... | NCT07338396

NCT07338396

Status Module

Sponsor/Collaborators Module

Name	Class
Beijing Chest Hospital	OTHER
Guang'anmen Hospital of China Academy of Chinese Medical Sciences	OTHER
Sichuan Cancer Hospital and Research Institute	OTHER

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Advanced Cohort		Participants in this cohort are patients with stage IIIb-IV non-small cell lung cancer (NSCLC) harboring an EGFR sensitizing mutation, who are receiving or are planned to receive first-line EGFR-TKI therapy within 2 weeks as their first-line treatment.	Drug: EGFR-TKI
Postoperative Cohort		Participants in this cohort are patients who have undergone complete surgical resection (R0) for NSCLC with an EGFR sensitizing mutation and who are receiving or are planned to receive adjuvant EGFR-TKI therapy within 2 weeks as their postoperative treatment.	Drug: EGFR-TKI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EGFR-TKI	Drug	Standard treatment with EGFR tyrosine kinase inhibitors (e.g., gefitinib, erlotinib, osimertinib) for NSCLC. The study observes its association with TCM syndrome patterns.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-Free Survival	Progress free survival defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Disease-Free Survival	From the date of surgery until the date of first documented tumor recurrence, distant metastasis, or death from any cause, whichever occurs first.	From the date of surgery until the date of first documented tumor recurrence, distant metastasis, or death from any cause, assessed up to 5 years.

Secondary Outcomes

Measure	Description	Time Frame
Objective Response Rate	Objective response rate is defined as the proportion of patients achieving complete (CR) or partial (PR) response according to RECIST V.1.1 criteria.	Through study completion, an average of 3 years.
Disease Control Rate

Other Outcomes

Measure	Description	Time Frame
Traditional Chinese Medicine (TCM) Syndrome Classification	Tongue and pulse characteristics will be collected using standardized and validated tongue diagnosis and pulse diagnosis devices. Standardized symptom information (e.g., fatigue, poor appetite) will be collected by licensed TCM practitioners. Symptoms will be recorded as present or absent without severity grading. Based on tongue, pulse, and symptom information, TCM practitioners will determine and classify each participant's TCM syndrome pattern (e.g., cold syndrome, heat syndrome) at each assessment time point.

Eligibility Module

Contacts/Locations Module

Name	Role	Phone	Extension	Email
Lina Ding	Contact	86-020-81887233		2804138491@qq.com
Yanjuan Zhu, MD	Contact	86-020-81887233		zyjsophy@gzucm.edu.cn

Facility	Status	City	State	ZIP	Country	Contacts
Beijing chest Hospital		Beijing	Beijing Municipality	100000	China

References Module

No data available