Back to results

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

Primary Purpose

Non-small Cell Lung Cancer

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Gefitinib

Gemcitabine +Carboplatin

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring chemotherapy, maintenance therapy, gefitinib

Eligibility Criteria

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

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.
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.

Sites / Locations

Shanghai Lung Tumor Clinical Center,Shanghai Chest Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gemcitabine +Carboplatin +Gefitinib

Gemcitabine +Carboplatin

Arm Description

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

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

Outcomes

Primary Outcome Measures

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 .

Secondary Outcome Measures

Full Information

NCT ID

NCT01404260

First Posted

July 26, 2011

Last Updated

December 4, 2016

Sponsor

Guangdong Association of Clinical Trials

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01404260

Brief Title

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

Acronym

ISCAN

Official Title

Intercalating and Maintenance Use of Iressa vs. Chemotherapy in Selected Advanced NSCLC: a Randomised Study

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangdong Association of Clinical Trials

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 .

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.

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

chemotherapy, maintenance therapy, gefitinib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

219 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gemcitabine +Carboplatin +Gefitinib

Arm Type

Experimental

Arm Description

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

Arm Title

Gemcitabine +Carboplatin

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Gefitinib

Other Intervention Name(s)

Iressa

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Gemcitabine +Carboplatin

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression Free Survival

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shun Lu, MD.

Organizational Affiliation

Guangdong Province Clinical Trial Association

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai Lung Tumor Clinical Center,Shanghai Chest Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200030

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

We'll reach out to this number within 24 hrs