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A Prospective, Non-interventional, Real-World Study on Patient-Reported Outcomes of Third-Generation EGFR-TKIs Combined with Radiotherapy for Advanced NSCLC Patients with EGFR Mutations

A Prospective, Non-interventional, Real-World Study on Patient-Reported Outcomes of Third-Generation EGFR-TKIs Combined with Radiotherapy for Advanced NSCLC Patients with EGFR Mutations

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121548
Enrollment
Unknown
Registered
2026-03-31
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-04-14

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

Interventions

Observation group of non-small cell lung cancer:None

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 years or above, diagnosed with stage IV (according to the 8th edition of AJCC) or stage III NSCLC that is not surgically resectable through histological or cytological examination. 2. Confirmed to have EGFR sensitive mutations (including but not limited to 19del or L858R) through laboratory tests. 3. Currently receiving or planning to receive third-generation EGFR-TKIs (such as osimertinib, aminorestatinib, volunetinib, etc.) and planning to combine with radiotherapy. 4. Have signed the informed consent form (signed by the individual or their legal guardian) and are willing to follow the study follow-up plan.

Exclusion criteria

Exclusion criteria: 1. There are clear contraindications for three generations of EGFR-TKI or radiotherapy (such as: allergy to the active ingredients or excipients of targeted drugs; history of interstitial pneumonia; inability to tolerate the planned dose of important organs within the radiotherapy field, etc.). 2. According to the investigator's assessment, patients who are scheduled to switch to other systemic treatments, including chemotherapy, immunotherapy, or anti-angiogenic therapy, etc. 3. The expected survival period is less than 3 months, or the ECOG score is >= 3 points. 4. Within the past 5 years, there has been a history of other malignant tumors, but they have been completely relieved and do not require further treatment (such as cervical carcinoma in situ, papillary thyroid carcinoma, etc.). 5. According to the investigator's judgment, there are any circumstances that would make it inappropriate for the patient to participate in this study in their best interest (such as harming the patient's health) or may hinder, limit or interfere with the evaluation as stipulated in the research protocol.

Design outcomes

Primary

MeasureTime frame
Patient-Reported Outcome Assessment;Patient and Disease Characteristics Assessment;Treatment Pattern Assessment;

Secondary

MeasureTime frame
Efficacy Assessment;Safety Assessment;Disease Progression Assessment;

Countries

China

Contacts

Public ContactYongmei Liu

West China Hospital of Sichuan University

lymi75@163.com+86 189 8060 6593

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026