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Study for efficacy and safety of continuing to treat with TKI combined with Anlotinib monotherapy in advanced NSCLC patients with T790M mutation-negative after TKI treatment failure

Study for efficacy and safety of continuing to treat with TKI combined with Anlotinib monotherapy in advanced NSCLC patients with T790M mutation-negative after TKI treatment failure

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900026416
Enrollment
Unknown
Registered
2019-10-09
Start date
2019-10-08
Completion date
Unknown
Last updated
2019-10-14

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

Conditions

Lung adenocarcinoma

Interventions

single arm: TKI combined with Anlotinib monotherapy

Sponsors

Henan Cancer Hospital / Affiliated Cancer Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) aged 18-75 years, 0-1 ECOG PS score; 2) pathologically diagnosed as advanced (stage IIIB/IV) non-small cell lung cancer with measurable lesions; 3) disease progression after being treated with an EGFR sensitive mutation (19del/L858R) and receiving a single generation of EGFR TKI (according to RESIST criteria); 4) biopsy can be performed after disease progression, and EGFR test T790M mutation is negative; 5)The functions of other major organs meet the requirements.

Exclusion criteria

Exclusion criteria: 1) small-cell carcinoma mixed with non-small-cell carcinoma, central, hollow lung squamous carcinoma, or patients with non-small-cell lung cancer accompanied by hemoptysis (>50 mL/day); 2) patients with brain metastasis with symptoms or with symptom control time less than 2 months; 3) patients whose tumors have invaded important blood vessels or who, according to the researcher's judgment, are likely to have massive bleeding during the follow-up study; 4) patients with any physical signs or history of bleeding.

Design outcomes

Primary

MeasureTime frame
Objective remission rate;

Secondary

MeasureTime frame
Disease control rate;Overall survival;

Countries

China

Contacts

Public ContactHuijuan Wang

Henan Cancer Hospital / Affiliated Cancer Hospital of Zhengzhou University

18638561588@163.com+86 18638561588

Outcome results

None listed

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