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Recombinant Mutated Human TNF in Combination?with Docetaxel and Carboplatin/Cisplatin in Patients with Stage IIIB/IV Non-Small-Cell Lung Cancer: A Randomized, Phase III Study

Recombinant Mutated Human TNF in Combination?with Docetaxel and Carboplatin/Cisplatin in Patients with Stage IIIB/IV Non-Small-Cell Lung Cancer: A Randomized, Phase III Study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-14005500
Enrollment
Unknown
Registered
2014-11-14
Start date
2002-11-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Advanced Lung Cancer

Interventions

A:docetaxel and platinum
B:chemotherapy plus rmhTNF

Sponsors

Clinical Pharmacology Research Base of West China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Eligible patients (older than 18 years) were required to have histologically or cytologically con?rmed stage IIIB/IV NSCLC. Other inclusion criteria were measurable lesions as defined by the Response Evaluation Criteria in Solid Tumors (RECIST version 3.0), an European Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1, predicted life expectancy longer than at least 12weeks from ?rst study-drug dose, and adequate hematologic, hepatic, cardiac and renal function. A washout period from previous treatments was required (2 to 6 weeks).

Exclusion criteria

Exclusion criteria: Exclusion criteria included hemoptysis (1/2 tsp or more per event); central nervous system metastases; pregnancy or lactation; a history of documented hemorrhagic diathesis or coagulopathy; therapeutic anticoagulation; regular use of aspirin (more than 325 mg per day), nonsteroidal antiinflammatory agents, or other agents known to inhibit platelet function; a history of hypersensitivity to paclitaxel, polypeptide drugs or biologics; and previous exposure to taxanes.

Design outcomes

Primary

MeasureTime frame
responds survival;

Countries

China

Contacts

Public ContactYingqi Zhang
zhangyqh@fmmu.edu.cn+86 13809188261

Outcome results

None listed

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