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

Primary Purpose

Non-small-cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nimotuzumab
docetaxel and cisplatin
daily RT to the chest
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small-cell Lung Cancer focused on measuring Nimotuzumab, Chemoradiotherapy,Squamous Cell Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sun yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nimotuzumab

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

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

Full Information

First Posted
October 12, 2015
Last Updated
February 8, 2021
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02577341
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
October 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small-cell Lung Cancer
Keywords
Nimotuzumab, Chemoradiotherapy,Squamous Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nimotuzumab
Arm Type
Experimental
Arm Description
Daily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin, and concurrent weekly Nimotuzumab.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Daily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin.
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab
Intervention Description
Patients received weekly nimotuzumab (200mg, IV) concurrent with chemoradiotherapy.
Intervention Type
Drug
Intervention Name(s)
docetaxel and cisplatin
Intervention Description
Patients received weekly docetaxel and cisplatin, each of 1 day's duration,concurrent with chest radiotherapy
Intervention Type
Radiation
Intervention Name(s)
daily RT to the chest
Intervention Description
Patients received daily RT to the chest
Primary Outcome Measure Information:
Title
overall survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Objective Response Rate
Time Frame
3 years
Title
progression-free survival
Time Frame
3 years
Title
rate of grade 3-4 radiation esophagitis
Description
rate of grade 3-4 radiation esophagitis as assessed by CTCAE v4.0
Time Frame
1 years
Title
rate of grade 3-4 radiation pneumonitis
Description
rate of grade 3-4 radiation pneumonitis as assessed by CTCAE v4.0
Time Frame
1 year
Title
Failure patterns
Description
rates of local-regional recurrence, distant metastasis and brain metastasis
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Liu, Professor
Organizational Affiliation
Sun yat-sen universtiy cancer center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

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Citation
Li LF, Wang HQ, Liu XM, Zhang HL, Qiu LH, Qian ZZ, Li W. [Nimotuzumab in combination with chemotherapy in patients with advanced non-small cell lung cancer]. Zhonghua Zhong Liu Za Zhi. 2011 Aug;33(8):626-8. Chinese.
Results Reference
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PubMed Identifier
24966687
Citation
Babu KG, Prabhash K, Vaid AK, Sirohi B, Diwakar RB, Rao R, Kar M, Malhotra H, Nag S, Goswami C, Raina V, Mohan R. Nimotuzumab plus chemotherapy versus chemotherapy alone in advanced non-small-cell lung cancer: a multicenter, randomized, open-label Phase II study. Onco Targets Ther. 2014 Jun 13;7:1051-60. doi: 10.2147/OTT.S63168. eCollection 2014.
Results Reference
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Nimotuzumab Combined With Chemoradiotherapy for Unresectable Locally Advanced Squamous Cell Lung Cancer

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