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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Guangdong Association of Clinical Trials
Sponsor:
Collaborators:
First Hospital of Jilin University
Ruijin Hospital
Fudan University
Jiangsu Cancer Institute & Hospital
Nanjing PLA General Hospital
Fourth People's Hospital of Wuxi
The First Affiliated Hospital of Soochow University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sir Run Run Shaw Hospital,School of Medicine, Zhejiang University
Henan Cancer Hospital
Changhai Hospital
NanJing PLA 81 Hospital
First People's Hospital of Hangzhou
Information provided by (Responsible Party):
Lu shun, Guangdong Association of Clinical Trials
ClinicalTrials.gov Identifier:
NCT01404260
First received: July 26, 2011
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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 .


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: gefitinib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intercalating and Maintenance Use of Iressa vs. Chemotherapy in Selected Advanced NSCLC: a Randomised Study

Resource links provided by NLM:


Further study details as provided by Guangdong Association of Clinical Trials:

Primary Outcome Measures:
  • RECIST1.1 [ Time Frame: eight weeks ] [ Designated as safety issue: Yes ]
    Patients were imaged with computed tomography (CT) scan.


Estimated Enrollment: 218
Study Start Date: June 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
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
gefitinib 250mg/d every cycle d15-25,and gefitinib 250mg/d from d15 of last cycle until disease progression
Other Name: Iressa
No Intervention: Arm B
gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression

Detailed Description:

Nowadays,EGFR mutation status is unknown for most of the advanced NSCLC patients in clinical practice.Those patients with high probability of EGFR mutation maybe could get benefit from gefitinib as first-line treatment. For this reason, the investigators need more investigation to focus on EGFR mutation unknown patients. In the previous study (including FAST-ACT), the patients enrolled trial received EGFR-TKI plus chemotherapy nearly simultaneously,so the investigators could not know whether those patients gained benefit from EGFR-TKI or chemotherapy, maybe chemotherapy alone was enough. If the patients with EGFR mutation status unknown could get stable disease(SD) after two cycles of chemotherapy,those patients may be optimal for the investigation of intercalating and maintenance administration of gefitinib. The reasons are that chemotherapy may be enough for those with objective response after two cycles chemotherapy, of course, those with disease progression (PD) should be excluded from the study.

On the basis of these and other studies, the investigators hypothesized that in a selected population,first-line chemotherapy(gemcitabine +carboplatin) with intercalating and maintenance use of gefitinib would be more efficacious than chemotherapy alone. In this study, the investigators compared the efficacy, safety, and adverse-event profile of chemotherapy plus gefitinib with those of chemotherapy alone, when these drugs were used as first-line treatment in nonsmokers or former light smokers in China, who had lung adenocarcinoma with EGFR gene mutation unknown.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Known severe hypersensitivity to gefitinib.
  • Patients with brain metastasis.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404260

Contacts
Contact: Shun Lu, MD. 86 21 62821990 ext 20312 yuyongfeng212@sina.com

Locations
China, Shanghai
Shanghai Lung Tumor Clinical Center,Shanghai Chest Hospital Recruiting
Shanghai, Shanghai, China, 200030
Contact: Shun Lu, MD.    86 21 62821990 ext 20312    yuyongfeng212@sina.com   
Sponsors and Collaborators
Lu shun
First Hospital of Jilin University
Ruijin Hospital
Fudan University
Jiangsu Cancer Institute & Hospital
Nanjing PLA General Hospital
Fourth People's Hospital of Wuxi
The First Affiliated Hospital of Soochow University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sir Run Run Shaw Hospital,School of Medicine, Zhejiang University
Henan Cancer Hospital
Changhai Hospital
NanJing PLA 81 Hospital
First People's Hospital of Hangzhou
Investigators
Principal Investigator: Shun Lu, MD. Guangdong Province Clinical Trial Association
  More Information

No publications provided

Responsible Party: Lu shun, Director of Department Shanghai Lung Tumor Clinical Center, Shanghai Chest Hospital, Guangdong Association of Clinical Trials
ClinicalTrials.gov Identifier: NCT01404260     History of Changes
Other Study ID Numbers: CTONG 1102
Study First Received: July 26, 2011
Last Updated: May 23, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Guangdong Association of Clinical Trials:
chemotherapy
maintenance therapy
gefitinib

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014