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Cancelled by the investigator. Public title: Real-World Study on the Effectiveness of Immunotherapy in EGFR-Mutated Non-Small Cell Lung Cancer Patients After Tyrosine Kinase Inhibitors Resistance

Immune checkpoint inhibitor combination therapy versus chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer (NSCLC) after resistance to targeted therapy: A real-world study on efficacy, safety, and predictive biomarkers.

Status
Unknown
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093673
Enrollment
Unknown
Registered
2024-12-10
Start date
2024-12-20
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Non-Small Cell Lung

Interventions

Chemotherapy group :None
Immune checkpoint inhibitor combination therapy group:None

Sponsors

Shanghai Pulmonary Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Men or women aged >=18 years. 2) Histologically or cytologically confirmed EGFR mutation-positive non-small cell lung cancer. 3) Received at least one TKI treatment and developed resistance. 4) ECOG physical status score of 0-2. 5) Patients must provide adequate medical records and imaging to assess efficacy and safety. 6) Patients must have at least one measurable lesion according to RECIST 1.1 criteria.

Exclusion criteria

Exclusion criteria: 1) EGFR mutation-positive patients with an indeterminate diagnosis of non-small cell lung cancer. 2) Other active malignancies within 5 years or concurrently. Cured limited tumors such as basal cell carcinoma of the skin, squamous carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, and carcinoma in situ of the breast may be enrolled. 3) Have severe heart disease or unstable angina. 4) Patients with active autoimmune disease or requiring immunosuppressive therapy. 5) Have severe infections such as HIV, active tuberculosis or hepatitis. 6) Have severe mental illness or cognitive impairment that affects treatment decisions. 7) Women who are pregnant or breastfeeding. 8) Patients with a known history of psychotropic substance abuse or addiction; patients with a history of alcoholism.

Design outcomes

Primary

MeasureTime frame
objective response rate;

Secondary

MeasureTime frame
disease control rate;progression free survival;overall survival;Adverse Event;

Countries

China

Contacts

Public ContactHe Yayi

Shanghai Pulmonary Hospital

15662723282@163.com+86 138 1882 8623

Outcome results

None listed

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