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

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02577341
• Collaborator: (none)
• Enrollment: 122
• Location: 1
• Arms: 2
• Duration (Months): 62
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-small-cell Lung Cancer	Drug: Nimotuzumab; Drug: docetaxel and cisplatin; Radiation: daily RT to the chest	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Randomized Phase Ⅱ Study of Nimotuzumab Combined With Chemoradiotherapy for Unresectable, Locally Advanced Squamous Cell Lung Cancer
• Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Jun 1, 2020
• Actual Study Completion Date: Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nimotuzumab Daily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin, and concurrent weekly Nimotuzumab.	Drug: Nimotuzumab; Patients received weekly nimotuzumab (200mg, IV) concurrent with chemoradiotherapy.; Drug: 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
Active Comparator: Control Daily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin.	Drug: 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

Outcome Measures

Primary Outcome Measures

1. overall survival [3 years]

Secondary Outcome Measures

1. Objective Response Rate [3 years]

2. progression-free survival [3 years]

3. rate of grade 3-4 radiation esophagitis [1 years]

   rate of grade 3-4 radiation esophagitis as assessed by CTCAE v4.0

4. rate of grade 3-4 radiation pneumonitis [1 year]

   rate of grade 3-4 radiation pneumonitis as assessed by CTCAE v4.0

5. Failure patterns [3 years]

   rates of local-regional recurrence, distant metastasis and brain metastasis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun yat-sen University Cancer Center	Guangzhou	Guangdong	China	510000

Sponsors and Collaborators

• Sun Yat-sen University

Investigators

• Principal Investigator: Hui Liu, Professor, Sun yat-sen universtiy cancer center

Study Documents (Full-Text)

None provided.

More Information

Publications

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• Responsible Party: Hui Liu, Professor, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT02577341
• Other Study ID Numbers: 2014-FXY-061
• First Posted: Oct 16, 2015
• Last Update Posted: Feb 11, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Hui Liu, Professor, Sun Yat-sen University: Nimotuzumab, Chemoradiotherapy,Squamous Cell Lung Cancer
• Additional relevant MeSH terms: Lung Neoplasms; Docetaxel; Nimotuzumab

Study Results

No Results Posted as of Feb 11, 2021