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Prospective Single-Arm Clinical Study Investigating and Optimizing the Clinical Efficacy and Safety of Targeted Combined Radiotherapy in Patients with Unresectable Stage III Non-Small Cell Lung Cancer Carrying EGFR Mutations

Prospective Single-Arm Clinical Study Investigating and Optimizing the Clinical Efficacy and Safety of Targeted Combined Radiotherapy in Patients with Unresectable Stage III Non-Small Cell Lung Cancer Carrying EGFR Mutations

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092180
Enrollment
Unknown
Registered
2024-11-12
Start date
2024-11-30
Completion date
Unknown
Last updated
2024-11-18

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

Conditions

Patients with Unresectable Stage IIIA/B EGFR-Positive NSCLC

Interventions

Treatment group:Third-generation EGFR TKIs will be administered for 3-6 months, during which the timing and protocol for concurrent radiotherapy will be determined ba

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients with histologically or cytologically confirmed AJCC TNM Stage IIIA/B (8th edition) unresectable EGFR-positive NSCLC, including histopathological subtypes such as lung adenocarcinoma and lung squamous cell carcinoma. 2.No prior first-line systemic anti-tumor therapy for advanced NSCLC; 3.Physical condition and organ function allow for systemic anti-tumor therapy, including radiotherapy and targeted therapy; 4.Age =18 years at the time of signing the informed consent form; 5.Availability of molecular pathology test results from blood samples and/or tumor tissue samples before the initiation of first-line treatment; 6.Ability to adhere to the planned schedule and actively cooperate with regular clinical follow-up and necessary treatment. 7.Willingness to provide the required clinical data for the study and consent to the use of test data for further scientific research and commercial product development.

Exclusion criteria

Exclusion criteria: 1.Patients with any other active malignancy within the 5 years prior to enrollment. Patients with cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ prostate cancer, in situ cervical cancer, and in situ breast cancer are eligible for enrollment; 2.Patients who have previously received systemic anti-tumor therapy for advanced NSCLC but do not have genetic testing results before the start of treatment; 3.Patients with other serious diseases that may affect follow-up and/or significantly shorten survival, as determined by the investigator. 4.Patients with any other conditions or social/psychological issues that the investigator deems unsuitable for participation in this study. 5.Patients who cannot undergo clinical follow-up using contrast-enhanced magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT).

Design outcomes

Primary

MeasureTime frame
2 year PFS ratio;

Countries

China

Contacts

Public ContactXiang Yi/Zhao Shengguang

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

xiangyiht@163.com+86 13816967846

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026