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

NCT02577341 | Completed Phase 2

• 1 other identifier: 2014-FXY-061
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small-cell Lung Cancer

Keywords

Nimotuzumab, Chemoradiotherapy,Squamous Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• overall survival

  3 years

Secondary Outcomes (5)

• Objective Response Rate

  3 years

• progression-free survival

  3 years

• rate of grade 3-4 radiation esophagitis

  1 years

• rate of grade 3-4 radiation pneumonitis

  1 year

• Failure patterns

  3 years

Study Arms (2)

Nimotuzumab

EXPERIMENTAL

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

Drug: Nimotuzumab; Drug: docetaxel and cisplatin; Radiation: daily RT to the chest

Control

ACTIVE COMPARATOR

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

Drug: docetaxel and cisplatin; Radiation: daily RT to the chest

Interventions

Nimotuzumab DRUG

Patients received weekly nimotuzumab (200mg, IV) concurrent with chemoradiotherapy.

Nimotuzumab

docetaxel and cisplatin DRUG

Patients received weekly docetaxel and cisplatin, each of 1 day's duration,concurrent with chest radiotherapy

Control; Nimotuzumab

daily RT to the chest RADIATION

Patients received daily RT to the chest

Control; Nimotuzumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

nimotuzumab; Docetaxel; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Hui Liu, Professor

  Sun yat-sen universtiy cancer center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: October 16, 2015
• Study Start: August 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: October 1, 2020
• Last Updated: February 11, 2021

Record last verified: 2021-02

Locations

CN (1)