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A single center, open label, phase 2 study of Surufatinib combined with docetaxel as second line treatment in EGFR wild type non-squamous non-small-cell lung cancer patients

A single center, open label, phase 2 study of Surufatinib combined with docetaxel as second line treatment in EGFR wild type non-squamous non-small-cell lung cancer patients

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047313
Enrollment
Unknown
Registered
2021-06-12
Start date
2021-06-30
Completion date
Unknown
Last updated
2022-02-01

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

Group A:Surufatinib

Sponsors

Guangxi Medical University Affiliated Tumor Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years; 2. Pathologically diagnosed late (stage IV), EGFR wild type; 3. ECOG PS 0-1; 4. Previous drug treatment consisted of a platinum-based chemotherapy regimen (> 1 chemotherapy regimen) for relapse or failure of treatment; 5. Sign the inform consent form with good compliance.

Exclusion criteria

Exclusion criteria: 1. Patients who had previously received Surufatinib treatment were excluded; 2. Patients with active brain metastasis, carcinomatous meningitis, or spinal compression, or disease of brain or pia mater according to the screening test, imaging, CT or MRI tests (patients who have completed the treatment and in a stable condition 21 days before screening could be included, but brain MRI, CT or venography is required to confirm that there are no brain hemorrhage symptoms); 3. Patients with uncontrollable hypertension (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg, despite optimal drug therapy); 4. Patients with with grade II myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male >= 450 ms, female >= 470 ms); 5. According to NYHA standard, grade III ~ IV heart failure, or cardiac color Doppler ultrasound examination showed left ventricular ejection fraction (LVEF) = ++ or verifies that the 24-h urine protein quantitation >= 1.0 g; 7. Onditions determined by investigators to possibly affect the clinical study or determination of the study results.

Design outcomes

Primary

MeasureTime frame
Progression-Free Survival, PFS;

Countries

China

Contacts

Public ContactYu Qitao

Guangxi Medical University Affiliated Tumor Hospital

yuqitaoac@126.com+86 13367816089

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026