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

NCT ID: NCT02577341

Last Updated: 2021-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2020-10-31

Brief 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.

Detailed 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.

Conditions

Non-small-cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nimotuzumab

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

Group Type: EXPERIMENTAL

Nimotuzumab

Intervention Type: DRUG

Patients received weekly nimotuzumab (200mg, IV) concurrent with chemoradiotherapy.

docetaxel and cisplatin

Intervention Type: DRUG

Patients received weekly docetaxel and cisplatin, each of 1 day's duration,concurrent with chest radiotherapy

daily RT to the chest

Intervention Type: RADIATION

Patients received daily RT to the chest

Control

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

Group Type: ACTIVE_COMPARATOR

docetaxel and cisplatin

Intervention Type: DRUG

Patients received weekly docetaxel and cisplatin, each of 1 day's duration,concurrent with chest radiotherapy

daily RT to the chest

Intervention Type: RADIATION

Patients received daily RT to the chest

Interventions

Nimotuzumab

Patients received weekly nimotuzumab (200mg, IV) concurrent with chemoradiotherapy.

Intervention Type: DRUG

docetaxel and cisplatin

Patients received weekly docetaxel and cisplatin, each of 1 day's duration,concurrent with chest radiotherapy

Intervention Type: DRUG

daily RT to the chest

Patients received daily RT to the chest

Intervention Type: RADIATION

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Hui Liu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hui Liu, Professor

Role: PRINCIPAL_INVESTIGATOR

Sun yat-sen universtiy cancer center

Locations

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

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Other Identifiers

2014-FXY-061

Identifier Type: -

Identifier Source: org_study_id