Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
Gefitinib, Recurrence, Carcinoma, Non-Small-Cell Lung
Brief summary
A single arm, open label, prospective, phase II trial of Gefitinib retreatment for the advanced or metastatic (IIIb and IV) NSCLC patients who previously responded to gefitinib And progressive disease should be observed with at least one prior regimen following previous gefitinib failure. Primary endpoint * to assess Disease Control Rate (Remission + Stable disease) Secondary endpoints * to assess the progression free survival
Interventions
DRUGGefitinib retreatment
phase II trial of Gefitinib retreatment for the advanced or metastatic (IIIb and IV) NSCLC patients who previously responded to gefitinib And progressive disease should be observed with at least one prior regimen following previous EGFR-TKI failure.
Sponsors
AstraZeneca
Chonnam National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Recurrent or progressive Non-Small Cell Lung Cancer (NSCLC) stage IV or IIIB patients after chemotherapy following gefitinib failure * Male and female patients aged over 18 years * World Health Organization (WHO) performance status 0-2 (those with performance status 2 must have been stable with no deterioration over the previous 2 weeks) * Had at least stable disease with previous Gefitinib treatment * Had at least one anticancer agent therapy after gefitinib failure ;Following treatment with another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs)- erlotinib or other TKIs should not be included in anticancer agent therapy. * The current approved indication of Gefitinib is 2nd or 3rd line monotherapy for recurrent or metastatic NSCLC. However, in practice with off-label indication, it can also be used as a 1st line treatment at the patient's own expenses. Thus, in this trial gefitinib retreatment will be 3rd line or more. * Measurable lesion according to Response Evaluation Criteria in Solid Tumors(RECIST) with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site. * Provision of written informed consent * Life expectancy of at least 12 weeks
Exclusion criteria
* Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded) * Expected life expectancy less than 2 months * Known severe hypersensitivity to gefitinib or any of the excipients of this product * Any unresolved chronic toxicity greater that Common Terminology Criteria (CTC) grade 2 from previous anticancer therapy * As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) * Serum bilirubin greater than 3 times the upper limit of reference range (ULRR) * Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x Upper Limit Normal (ULN) if no demonstrable liver metastases (or \>5 x in presence of liver metastases) * Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study * Pregnancy or breast-feeding women (women of child¬bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy. * Newly diagnosed central nervous system (CNS) metastases that have not yet been treated with surgery and/or radiation. Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically stable disease (no steroid therapy or steroid dose being tapered) for at least 2 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control(DC) Rate of Gefitinib Retreatment Per RECIST Criteria (V1.1) and Assessed by CT | 8 weeks | Evaluation of treatment response by computed tomography (CT) was performed after the first 4 weeks according to version 1.1 of the guidelines set out by Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Disease control rate (DCR) was defined as the percentage sum of best tumor response of complete response (CR), partial response (PR), and stable disease (SD). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression - Free Survival of Patients Retreated With Gefitinib | two year | Progression is defined, using RECIST (V1.1), as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline using CT scan every 8 weeks. |
| Overall Survival | 2 years | — |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Gefitinib retreatment | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 14 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age Continuous | 64.9 years STANDARD_DEVIATION 7.2 |
| Region of Enrollment Korea, Republic of | 23 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 23 |
| serious Total, serious adverse events | 3 / 23 |
Outcome results
Primary
Disease Control(DC) Rate of Gefitinib Retreatment Per RECIST Criteria (V1.1) and Assessed by CT
Evaluation of treatment response by computed tomography (CT) was performed after the first 4 weeks according to version 1.1 of the guidelines set out by Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Disease control rate (DCR) was defined as the percentage sum of best tumor response of complete response (CR), partial response (PR), and stable disease (SD).
Time frame: 8 weeks
Population: we analysed the data of 23 patients who were enrolled to this study(intention-to-treat (ITT) population).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib Retreatment Arm | Disease Control(DC) Rate of Gefitinib Retreatment Per RECIST Criteria (V1.1) and Assessed by CT | 65.2 percentage of participant with DC |
Secondary
Overall Survival
Time frame: 2 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gefitinib Retreatment Arm | Overall Survival | 343 days |
Secondary
Progression - Free Survival of Patients Retreated With Gefitinib
Progression is defined, using RECIST (V1.1), as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline using CT scan every 8 weeks.
Time frame: two year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gefitinib Retreatment Arm | Progression - Free Survival of Patients Retreated With Gefitinib | 103 days |