Stage IB-IIIA Non-small Cell Lung Carcinoma with EGFR-positive tumors MedDRA version: 17.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Tarceva 25mg Film-Coated Tablet
Pharmaceutical Form: Tablet
INN or Proposed INN: Erlotinib
CAS Number: 183319-69-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
OSI Pharmaceuticals, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for participation in the Screening portion of this study, patients must meet all of the following inclusion criteria: A. Histologically confirmed diagnosis of stage IB-IIIA NSCLC. - Patients with bronchoalveolar carcinoma that presents as a single, solitary, discrete nodule or mass may be included; - Patients with preoperative radiological evidence of N2 disease by either PET or CT scan (ie, radiological evidence of metastasis to ipsilateral mediastinal and subcarinal lymph nodes) that is confirmed as N2 disease histologically are excluded. However, patients determined to have microscopic N2 disease, that was not radiologically obvious preoperatively, can be included; - Patients with histologically confirmed intralobar satellites (T4) are not eligible for this study. B. Patients treated by a segmentectomy or wedge resection are not eligible for this study. Additionally, patients must have had a nodal dissection of 2 separate mediastinal nodal stations or nodal sampling of 2 separate mediastinal nodal stations (levels 4, 7, and 9 for right-sided tumors and levels 5, 6, 7, and 9 for left-sided tumors are strongly suggested); C. Age greater than or equal to 18 years; D. Written informed consent to participate in the Screening portion of the study. To be eligible for participation in the On-treatment portion of this study, patients must continue to meet all of the Screening inclusion criteria as well as all of the following Treatment inclusion criteria: 1. Primary tumor tissue from patient’s surgical resection must be analyzed by the central laboratory and determined to be EGFR-positive by IHC and/or FISH. This is a mandatory requirement for entry; 2. Patients may have completed up to a total of 4 cycles of adjuvant chemotherapy using a standard (non-investigational), 2-drug, platinum-based regimen OR may not have received adjuvant chemotherapy for NSCLC. Patients who have received adjuvant chemotherapy must have recovered from the acute side effects before randomization; 3. Ability to be randomized within the following timelines: 6 months (= 180 days) from the day of surgical resection for patients who receive adjuvant chemotherapy and 3 months (less than or equal to 90 days) from the day of surgical resection for patients who do not receive adjuvant chemotherapy; 4. Ability to take oral medications; 5. An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 – 2 6. Patients with reproductive potential (ie, pre-menopausal females, females who have been menopausal for < 1 year and not surgically sterilized, or males not surgically sterilized) must practice effective contraceptive measures for the duration of study drug therapy and for at least 30 days after completion of study drug therapy. Female patients of child-bearing potential must provide a negative pregnancy test (serum) less than or equal to 14 days before randomization; 7. Adequate hematopoietic, renal and hepatic functions as defined by the following required laboratory values obtained less than or equal to 14 days before randomization: ANC Greater than or equal to 1.0 x 10 9/L Platelet count Greater than or equal to 75 x 10 9/L Serum creatinine Less than or equal to 1.5 times the ULN (Less than or equal to 3.0 times the ULN if due to platinum adjuvant chemotherapy) Total bilirubin Less than or equal to 1.5 times the ULN ALT (SGPT) Less than or equal to 2.5 times the ULN 8. Written informed consent to participate in th
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria are not eligible to be screened for this study: A. Patients with mixed histology of small cell and non-small cell carcinoma, or pulmonary carcinoid tumors, or large cell carcinoma with evidence of neuroendocrine features. Patients who have tumors with mixed adenocarcinoma and squamous cell carcinoma histology are eligible; B. Patients with preoperative radiological evidence of N2 disease by either PET or CT scan (ie, radiological evidence of metastasis to ipsilateral mediastinal and subcarinal lymph nodes) that is confirmed as N2 disease histologically are excluded. In addition, patients who have histologically confirmed positive bronchial margins are also excluded; C. History of prior radiotherapy for NSCLC either as neoadjuvant or adjuvant therapy; D. Patients who received neoadjuvant chemotherapy for NSCLC; E. History of significant cardiac disease, (eg, uncontrolled high blood pressure, unstable angina, uncontrolled congestive heart failure, myocardial infarction) or uncontrolled cardiac arrhythmias within the previous year; F. History of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (eg, Crohn’s disease, ulcerative colitis, etc.); G. History of other prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in-situ cervical cancer. Patients with other malignancies are eligible if they have remained disease free for at least 5 years; H. History of a neurologic or psychiatric condition that might impair the patient’s ability to understand or to comply with the requirements of the study or to provide informed consent; I. Prior treatment with any EGFR inhibitor. Patients who meet any of the Screening exclusion criteria or any of the following Treatment exclusion criteria are not eligible to be randomized for this study: 1. Tumor tissue from the patient’s surgical resection determined to be EGFR-negative by both IHC and FISH. If an individual tissue test result is inconclusive (unable to be determined), it will be considered negative for study eligibility purposes 2. Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient’s ongoing participation in the study; 3. Ocular inflammatory or infectious conditions that have not been completely resolved before randomization; 4. Pregnant or breast-feeding females; 5. Participation in another investigational drug trial while on-study; 6. Hypersensitivity to erlotinib or to any of the excipients contained in the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the efficacy of single-agent, oral, once daily, Tarceva (150 mg/day) at increasing the DFS following complete surgical resection with or without adjuvant chemotherapy in patients who have EGFR-positive tumor tissue (by IHC and/or FISH).;Secondary Objective: The key secondary objectives are to: • Compare the OS between study arms in all randomized patients; • Compare the DFS between study arms in patients with EGFR mutation-positive tumors; and • Compare the OS between study arms in patients with EGFR mutation-positive tumors. Additional secondary objectives are to: • Evaluate the safety of Tarceva; and • Explore the prognostic and predictive value of EGFR-related biomarkers and other biomarkers (including EGFR gene copy number by FISH) that may be associated with clinical outcomes following treatment with Tarceva. ;Primary end point(s): DFS will be defined as time from the date of randomization until the first day NSCLC relapse is documented by radiological examination and/or biopsy, or until death in the absence of relapse. The investigator-determined date of relapse will be used for analysis of DFS. Patients who do not relapse will be censored on the last radiological assessment/biopsy date or on the date of the last visit for patients still on protocol therapy. Patients who receive other therapy for NSCLC before documented disease relapse (eg, radiotherapy or other chemotherapy) will be censored on the last radiological assessment/biopsy date prior to the date of alternative therapy. | — |
Countries
Austria, Belgium, Czech Republic, France, Germany, Greece, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed