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

Sun Yat-sen University

Status and phase: Completed; Phase 2

Conditions: Non-small-cell Lung Cancer

Treatments: Drug: Nimotuzumab; Drug: docetaxel and cisplatin; Radiation: daily RT to the chest

Study type: Interventional

Funder types: Other

Identifiers

NCT02577341

2014-FXY-061

Details and patient eligibility

About

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.

Full description

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

All patients were planned to receive radical dose of chest radiation and concurrent chemotherapy of weekly docetaxel and cisplatin, each of 1 day's duration.

Nimotuzumab group was treated with weekly nimotuzumab (200mg, IV) combined with chemoradiotherapy, while control group was treated with chemoradiotherapy.

Enrollment: 122 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Nimotuzumab

Experimental group

Description:

Daily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin, and concurrent weekly Nimotuzumab.

Treatment:

Radiation: daily RT to the chest

Drug: Nimotuzumab

Drug: docetaxel and cisplatin

Control

Active Comparator group

Description:

Daily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin.

Treatment:

Radiation: daily RT to the chest

Drug: docetaxel and cisplatin