Nimotuzumab Combined With Chemoradiotherapy for Unresectable Locally Advanced Squamous Cell Lung Cancer

• Status: Completed
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab in combined with chemoradiotherapy for unresectable,local advanced squamous cell lung cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Cisplatin; Docetaxel; Nimotuzumab

Criteria

Inclusion Criteria:

• histologically confirmed squamous cell lung cancer

• patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria

• unresectable phase IIIA(N2) and IIIB lung cancer confirmed by CT or MRI

• ECOG performance status 0-1

• Previously treated with chemotherapy or treatment-naive

• no previous chest radiotherapy, immunotherapy or biotherapy.

• hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL

• serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min

• bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL

• FEV1 >0.8 L

• CB6 within normal limits

• patients and their family signed the informed consents

Exclusion Criteria:

• adenosquamous carcinoma

• previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ

• contraindication for chemotherapy

• women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose

• women who has the probability of pregnancy without contraception

• tendency of hemorrhage

• in other clinical trials within 30 days

• addicted in drugs or alcohol, AIDS patients

• uncontrollable seizure or psychotic patients without self-control ability

• severe allergy or idiosyncrasy

• not suitable for this study judged by researchers