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A real-world study of anlotinib hydrochloride combined with third-generation EGFR-TKIs in the treatment of locally advanced / advanced non-small cell lung cancer with slow progression of EGFR-TKIs.

A real-world study of anlotinib hydrochloride combined with third-generation EGFR-TKIs in the treatment of locally advanced / advanced non-small cell lung cancer with slow progression of EGFR-TKIs.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500109643
Enrollment
Unknown
Registered
2025-09-23
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-29

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

Conditions

lung cancer

Interventions

Observation group:None

Sponsors

Shaoxing People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged between 18 and 75 years (inclusive); 2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC (all histological types); 3. Detection confirmed EGFR mutations (including 19del and 21 L858R, excluding 20 exon insertions), accepting pathological examination results from other hospitals; 4. After first-line monotherapy with third-generation EGFR-TKIs (allowing less than two cycles of chemotherapy in between treatments), if slow progression occurs, and the investigator assesses that continuing with the original third-generation EGFR-TKIs still provides benefit (original TKI dosage unchanged); Note: Patients who have had disease control for >=3 months after treatment with third-generation EGFR-TKIs and clinically show slow progression. Specifically defined as: a slight increase in tumor harm to the body compared to previous assessments (no worsening of symptoms); progression of non-target lesions, such as pleural effusion, or a total of up to 5 combined extra-cranial/intracranial progresses (local treatment methods can be used simultaneously/sequentially); 5. At least one measurable target lesion present in the last 3 months (according to RECIST version 1.1 standards); 6. ECOG score: 0-2.

Exclusion criteria

Exclusion criteria: 1. Small cell lung cancer (including mixed small cell lung cancer and non-small cell lung cancer); 2. Patients with primary resistance to third-generation EGFR-TKIs therapy (treatment duration = 2.4 months, rapid deterioration of clinical symptoms, significant progression of target lesions compared to the previous evaluation, and worsening symptoms); 4. Patients who underwent synchronous or sequential use of other systemic therapies after slow progression, such as chemotherapy, bevacizumab, etc.; 5. Patients who, as determined by the investigator, switched to other chemotherapy or targeted drugs after progression.

Design outcomes

Primary

MeasureTime frame
Imaging materials;

Secondary

MeasureTime frame
Tumor index test;

Countries

China

Contacts

Public ContactGuangmao Yu

Shaoxing People's Hospital

sxygmys@163.com+86 138 6756 1156

Outcome results

None listed

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