Neoadjuvant Nimotuzumab Plus Gemcitabine and Carboplatin in Unresectable Stage III Squamous Cell Lung Carcinoma

NCT02428764 | Withdrawn Phase 2 DMC

• 2 other identifiers: GASTO1010wsy006
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is studying induction nimotuzumab plus gemcitabine and carboplatin followed by surgery to see how well it works in treating patients with unresectable stage III squamous cell lung carcinoma.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Resectability rate

  3 months

Secondary Outcomes (3)

• Number of participants with perioperative complications

  1 year

• Event-free survival

  2 years after the last patient is enrolled

• Overall survival

  2 years after the last patient is enrolled

Study Arms (1)

Intervention group

EXPERIMENTAL

Patients were assigned to receive neoadjuvant nimotuzumab plus gemcitabine and carboplatin followed by surgery.

Drug: Nimotuzumab; Drug: Gemcitabine; Drug: Carboplatin; Procedure: Surgery

Interventions

Nimotuzumab DRUG

Nimotuzumab was given 200 mg i.v. injection over 30 min on days 1 and 8

Intervention group

Gemcitabine DRUG

Gemcitabine was given 1000 mg/m2 i.v. injection on days1 and 8.

Also known as: Gemzar

Intervention group

Carboplatin DRUG

carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 i.v. on day 1.

Also known as: CBP

Intervention group

Surgery PROCEDURE

Patients' resectability was assessed by a medical team, including thoracic surgeons, medical oncologists, and radiologists.

Intervention group

Eligibility Criteria

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

You may qualify if:

• Target population is unresectable stage III squamous cell lung carcinoma.
• Written informed consent provided.
• Male and female patients aged ≥18 years, ≤75 years.
• Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Life expectancy ≥12 weeks.
• Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
• Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.
• Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min.
• Female subjects should not be pregnant or breast-feeding.

You may not qualify if:

• Known severe hypersensitivity to nimotuzumab or any of the excipients of this product.
• Inability to comply with protocol or study procedures.
• A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
• A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.
• Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
• Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy).
• Patients with prior radiotherapy
• History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
• Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
• Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.
• Patient who has active serious infection (e.g. pyrexia of or 38.0℃ over).

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

nimotuzumab; Gemcitabine; Carboplatin; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• Si-Yu Wang, MD

  Guangdong Province Association Study of Thoracic Oncology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: April 29, 2015
• Study Start: April 1, 2015
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

CN (1)