Intercalating and Maintenance Use of Iressa Versus Chemotherapy in Selected Advanced Non Small Cell Lung Cancer

NCT01404260 | Completed Phase 3 Results DMC

• 1 other identifier: CTONG 1102
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

Brief Summary

Platinum-based combination chemotherapy, such as gemcitabine-carboplatin, is one of the standard first-line therapy for advanced non-small cell lung cancer (NSCLC). Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) have clinical efficacy, as compared with the best supportive care or standard chemotherapy, when given as second-line or third-line therapy for advanced NSCLC. Treatment with EGFR-TKI is most effective in female, never-smoker, or patients with adenocarcinoma, and patients of Asian origin. In these populations, such treatment is associated with favorable objective response rates, progression-free survival, and overall survival. These populations also have a relatively high incidence of somatic mutations in the region of the EGFR gene that encodes the tyrosine kinase domain. The recent study(IPASS) by Tony S. Mok showed gefitinib was superior to carboplatin-paclitaxel as an initial treatment for pulmonary adenocarcinoma among nonsmokers or former light smokers in East Asia . In the subgroup of 261 patients who were positive for the EGFR gene mutation, PFS was significantly longer among those who received gefitinib than among those who received carboplatin-paclitaxel(HR= 0.48,P\<0.001), whereas in the subgroup of 176 patients who were negative for the mutation, PFS was significantly longer among those who received carboplatin-paclitaxel(HR=2.85,P\<0.001). Gefitinib treatment was well tolerated, with lower in hematologic toxicity, and no treatment-related interstitial lung disease.In this study(IPASS), only patients with a mutation of the EGFR gene in the tumor could get benefit from gefitinib as first line treatment. Tony S. Mok and his colleague also found that intercalating and maintenance administration of erlotinib(another EGFR-TKI)following gemcitabine/platinum chemotherapy as first line therapy led to a significant improvement in PFS .

Conditions

Non-small Cell Lung Cancer

Keywords

chemotherapy; maintenance therapy; gefitinib

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or progression in existing non-target lesions,or the appearance of one or more new lesions .

  The evaluation of disease is demanded every two months for the patients receiving maintenance use of Gefitinib or patients in observation after chemotherapy,until disease progression occured

Study Arms (2)

Gemcitabine +Carboplatin +Gefitinib

EXPERIMENTAL

Arm A: Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, Gefitinib 250mg/d every cycle d15-25, and Gefitinib 250mg/d from d15 of last cycle until disease progression

Drug: Gefitinib; Drug: Gemcitabine +Carboplatin

Gemcitabine +Carboplatin

ACTIVE COMPARATOR

Arm B: Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression

Drug: Gemcitabine +Carboplatin

Interventions

Gefitinib DRUG

Gefitinib 250mg/d every cycle d15-25,and Gefitinib 250mg/d from d15 of last cycle until disease progression

Also known as: Iressa

Gemcitabine +Carboplatin +Gefitinib

Gemcitabine +Carboplatin DRUG

Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles

Gemcitabine +Carboplatin; Gemcitabine +Carboplatin +Gefitinib

Eligibility Criteria

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

You may qualify if:

• After two cycles chemotherapy(gemcitabine plus carboplatin), patients with stable disease(SD) by RECIST1.1.
• Patients between 18 and 75 years of age.
• Present with histologically proven or cytological diagnosis of adenocarcinoma NSCLC Stage IIIB or IV as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer, that is not amenable to curative therapy,such as surgery or radiotherapy and so on.
• No prior systemic chemotherapy or targeted therapy for lung cancer before screening.
• Never smokers(defined as having smoked less than 100 cigarettes in their lifetime ) or light ex-smokers (defined as having ceased smoking at least 15 years before Day 1 of study treatment and having smoked 10 pack-years or fewer).
• EGFR mutation status unknown.
• ECOG performance status of 0 or 1.
• Adequate organ function.
• Prior radiation therapy allowed to \<25% of the bone marrow . Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 4 weeks before study enrollment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment.
• Signed informed consent document on file.
• Estimated life expectancy of ≥12 weeks.
• Patient compliance and geographic proximity that allow adequate follow up.

You may not qualify if:

• Known severe hypersensitivity to gefitinib.
• Sympotomatic patients with brain metastases.
• Pleural effusion or pericardiac effusion that cannot be controlled by drainage or other procedures.
• 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.
• Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
• Interstitial pneumonia.

Sponsors & Collaborators

• Guangdong Association of Clinical Trials: lead
• The First Hospital of Jilin University: collaborator
• Ruijin Hospital: collaborator
• Fudan University: collaborator
• Jiangsu Cancer Institute & Hospital: collaborator
• Nanjing PLA General Hospital: collaborator
• Wuxi No. 4 People's Hospital: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• Sir Run Run Shaw Hospital: collaborator
• Henan Cancer Hospital: collaborator
• Changhai Hospital: collaborator
• NanJing PLA 81 Hospital: collaborator
• First People's Hospital of Hangzhou: collaborator

Study Sites (1)

Shanghai Lung Tumor Clinical Center,Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gefitinib

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)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Shun LU
• Organization: Shanghai Chest Hospital

shun_lu11@163.com

86-2162821990

Study Officials

• Shun Lu, MD.

  Guangdong Province Clinical Trial Association

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department Shanghai Lung Tumor Clinical Center, Shanghai Chest Hospital

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: July 28, 2011
• Study Start: June 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 27, 2017
• Results First Posted: January 27, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)