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Study for efficacy and safety of Anlotinib combined with TKI in advanced NSCLC patients after TKI treatment failure

Study for efficacy and safety of Anlotinib combined with TKI in advanced NSCLC patients after TKI treatment failure

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032840
Enrollment
Unknown
Registered
2020-05-12
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-05-18

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

single arm:Anlotinib combined with TKI

Sponsors

The Second Affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-75 years old, male or female, ECOG PS score : 0-2; 2. Expected survival not less than 12 weeks; 3. A histopathologically or cytologically diagnosed IIIB-IV stage non-small cell lung cancer, with a measurable lesions (according to RECIST 1.1 standard, tumor lesions on CT scan length >= 10 mm); 4. The EGFR gene status was detected by NGS as a sensitive mutation (19 exon deletion or 21 exon L858R site mutation); 5. After the first-line treatment with first-generation TKI, patients with slow disease progression were tested again for negative T790M; 6. No targeted drugs against tumor angiogenesis have been used before; 7. The fuctions of main organs are nomal.

Exclusion criteria

Exclusion criteria: 1. Small cell carcinoma mixed non-small cell carcinoma; 2. Symptomatic brain metastases; 3. Imaging (CT or MRI) showed that the tumor lesion was no more than 5mm away from the great vessels, or there was a central lung cancer invading into the local great vessels; 4. Patients with positive gene test results for T790M mutation; 5. Patients with hemoptysis or hemorrhagic disease, or with a high risk of bleeding.

Design outcomes

Primary

MeasureTime frame
Objective remission rate;

Secondary

MeasureTime frame
Disease control rate;PFS;Overall survival;

Countries

China

Contacts

Public ContactWeiliang Sun

The Second Affiliated Hospital of Guangxi Medical University

swl20022001@hotmail.com+86 13471023540

Outcome results

None listed

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