View Trial - USC/Norris Cancer Center Clinical Trials

Details for trial 2N-06-7

Description:	A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of Single-Agent Tarceva (Erlotinib) Following Complete Tumor Resection with or without Adjuvant Chemotherapy in Patients with Stage IB-IIIA Non-Small Cell Lung Carcinoma who have EGFR-Positive Tumors.
Status:	Open
Randomized?	Yes

Researchers

Principal Investigator	Title
Barbara Gitlitz	M.D.

Data Management

Name	Title
Charlean Ketchens	R.N.
Lagrimas Ilagan	D.M.
Vatche Stepanian	D.M.
Gina Tse	R.N.

You may participate in this study if:

	Requirement
1	Histologically confirmed Stage IB-IIIA non-small cell lung cancer(NSCLC). Bronchoalveolar carcinoma presenting as a single, solitary, discrete nodule or mass may be included.
2	Complete surgical resection -- defined as the appropriate pulmonary parenchymal resection including lobectomy, bilobectomy, sleeve lobectomy & pneumonectomy with histologically confirmed negative bronchial margins. Ineligible if treated by a segmentectomy or wedge resection.
3	Nodal dissection of 2 separate mediastinal nodal stations or nodal sampling of 2 separate mediastinal nodal stations (levels 4, 7, 9 for right-sided tumors; levels 5, 6, 7, 9 for left-sided tumors are strongly suggested).
4	18 y/o and above.
5	Primary tumor tissue from surgical resection must be analyzed by Central Lab & determined EGFR (+) by IHC &/or FISH. This is mandatory for study entry.
6	May have up to total of 4 cycles of adjuvant chemothearapy with standard, non-investigational, 2-drug, platinum-based regimen or may be chemotherapy-naïve.
7	Recovered from acute toxicities from the adjuvant chemotherapy prior to randomization.
8	Randomized within the following timelines: 6 mos (180 days or less) from surgical resection, if patient received adjuvant chemotherapy, and 3 mos (90 days or less) from surgical resection, if did not receive adjuvant chemotherapy.
9	Able to take oral medications.
10	ECOG 0-2.
11	Patients with reproductive potential (females who are pre-menopausal or menopausal < 1 yr & not surgically sterilized, or males not surgically sterilized) must practice effective contraception while on study & for at least 30 days after completion of study treatment.
12	Women of child-bearing potential must have (-) serum pregnancy test 14 days, or less, prior to randomization.
13	The following lab values must be 14 days, or less, before randomization: Absolute Neutrophil Count 1000 or greater; Platelets 75,0000 or greater; Serum creatinine 1.5 (or less) x ULN [or 3.0 (or less) x ULN if due to platinum adjuvant chemotherapy]; Total bilirubin 1.5 (or less) x ULN; ALT (SGPT) 2.5 (or less) x ULN.
14	Accessible for continued treatment & follow-up.
15	Signed Informed Consent, including HIPAA authorization.

You may not participate in this study if:

1	With presence of histologically confirmed intralobar satellites (T4).
2	N2 disease by pre-op PET or CT (metastases to ipsilateral mediastinal & subcarinal lymph nodes) & confirmed as N2 disease histologically. However, if determined to have microscopic N2 disease but not radiologically obvious pre-operatively, patient can be included.
3	Mixed histology of small cell & NSCLC or pulmonary carcinoid tumors, or large cell carcinoma with evidence of neuroendocrine features. Tumors with mixed adenocarcinoma & squamous cell histology are eligible.
4	With histologically confirmed positive bronchial margins.
5	Had prior radiotherapy for NSCLC (neoadjuvant or adjuvant).
6	Had neoadjuvant chemotherapy for NSCLC.
7	With history of significant cardiac disease (uncontrolled hypertension, unstable angina, uncontrolled heart failure, heart attack) or uncontrolled cardiac arrhythmias within the previous year.
8	With history of poorly controlled gastrointestinal disorders that could affect absorption (Crohn’s, ulcerative colitis, etc).
9	With history of other prior malignancy (except adequately treated basal cell cancer or squamous cell cancer of the skin or cervical carcinoma in-situ) unless patient has been disease-free for 5 yrs or more.
10	With history of neurologic or psychiatric condition that might impair ability to understand or comply with study requirements or to provide informed consent.
11	Had prior treatment withan EGFR inhibitor.
12	Tumor tissue from surgical resection EGFR is determined (-) by both IHC & FISH. If result inconclusive (undetermined), it will be considered negative for eligibility purposes.
13	Has active or uncontrolled infections or serious illnesses or medical conditions that could interfere with ongoing study participation.
14	Has ocular inflammatory or infectious conditions that have not completely resolved before randomization.
15	Pregnant or breast-feeding female.
16	Participating in another investigational drug trial.
17	Has hypersensitivity to erlotinib or any of the excipients contained in study drug.

For further information on, or to sign up for this study, please contact the Clinical Investigation Support Office at (323) 865-0451 or the Principal Investigator noted above.