Clinical trial NCT02577341: Nimotuzumab Combined With Chemoradiotherapy for Unresectable Locally Advanced Squamous Cell Lung Cancer
Official title: A Prospective Randomized Phase Ⅱ Study of Nimotuzumab Combined With Chemoradiotherapy for Unresectable, Locally Advanced Squamous Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small-cell Lung Cancer
Keywords: Nimotuzumab, Chemoradiotherapy,Squamous Cell Lung Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-10-16
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: overall survival
timeFrame: 3 years
Secondary outcomes:
measure: Objective Response Rate
timeFrame: 3 years
measure: progression-free survival
timeFrame: 3 years
measure: rate of grade 3-4 radiation esophagitis
timeFrame: 1 years
measure: rate of grade 3-4 radiation pneumonitis
timeFrame: 1 year
measure: Failure patterns
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun yat-sen universtiy cancer center
name: Hui Liu, Professor
role: PRINCIPAL_INVESTIGATOR
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