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

Non-small-cell Lung Cancer Clinical Trial

Official title:

A Prospective Randomized Phase Ⅱ Study of Nimotuzumab Combined With Chemoradiotherapy for Unresectable, Locally Advanced Squamous Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02577341
• Other study ID #: 2014-FXY-061
• Status: Completed
• Phase: Phase 2
• Start date: August 2015
• Est. completion date: October 2020

Study information

• Verified date: February 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: October 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Non-small-cell Lung Cancer

Intervention

Drug:
• Nimotuzumab
Patients received weekly nimotuzumab (200mg, IV) concurrent with chemoradiotherapy.
• docetaxel and cisplatin
Patients received weekly docetaxel and cisplatin, each of 1 day's duration,concurrent with chest radiotherapy

Radiation:
• daily RT to the chest
Patients received daily RT to the chest

Locations

Country	Name	City	State
China	Sun yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (47)

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		3 years
Secondary	Objective Response Rate		3 years
Secondary	progression-free survival		3 years
Secondary	rate of grade 3-4 radiation esophagitis	rate of grade 3-4 radiation esophagitis as assessed by CTCAE v4.0	1 years
Secondary	rate of grade 3-4 radiation pneumonitis	rate of grade 3-4 radiation pneumonitis as assessed by CTCAE v4.0	1 year
Secondary	Failure patterns	rates of local-regional recurrence, distant metastasis and brain metastasis	3 years