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

Phase 2

Completed

• Conditions: Non-small-cell Lung Cancer
• Interventions: Drug: docetaxel and cisplatin; Drug: Nimotuzumab; Radiation: daily RT to the chest

• Registration Number: NCT02577341
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-10-12
• Study First Submitted QC: 2015-10-14
• Study First Posted: 2015-10-16
• Primary Completion: 2020-06
• Study Completion: 2020-10
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nimotuzumab	daily RT to the chest	Daily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin, and concurrent weekly Nimotuzumab.
Control	docetaxel and cisplatin	Daily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin.
Control	daily RT to the chest	Daily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin.
Nimotuzumab	docetaxel and cisplatin	Daily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin, and concurrent weekly Nimotuzumab.
Nimotuzumab	Nimotuzumab	Daily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin, and concurrent weekly Nimotuzumab.

Primary Outcome Measures

Name	Time	Method
overall survival	3 years

Secondary Outcome Measures

Name	Time	Method
progression-free survival	3 years
Objective Response Rate	3 years
rate of grade 3-4 radiation esophagitis	1 years	rate of grade 3-4 radiation esophagitis as assessed by CTCAE v4.0
Failure patterns	3 years	rates of local-regional recurrence, distant metastasis and brain metastasis
rate of grade 3-4 radiation pneumonitis	1 year	rate of grade 3-4 radiation pneumonitis as assessed by CTCAE v4.0

Trial Locations

Locations (1)

Sun yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China