Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT00778167
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
* Stage IIIA, IIIB, or IV disease
* Mixed histology permitted provided small-cell elements are not present
* Measurable disease, defined as ≥ 1unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
* Must have failed ≥ 1 platinum-containing chemotherapy regimen
* CNS metastases are eligible if received prior radiotherapy to site(s) of CNS metastatic disease, or have had definitive resection of CNS metastatic disease and have no overt evidence of neurological deficits, are not requiring anti-epileptics, remain asymptomatic, and have been off steroids for ≥ 8 weeks
* ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
* Life expectancy \> 3 months
* Leukocytes ≥ 3,000/mm³
* Absolute neutrophil count ≥ 1,500/mm³
* Hemoglobin ≥ 9 g/dL
* Platelets ≥ 100,000/mm³
* Total bilirubin normal
* AST and ALT ≤ 2.5 times upper limit of normal (ULN)
* Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
* Fasting serum glucose \< 120 mg/dL OR normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to anti-IGF-1R recombinant monoclonal antibody IMC-A122 or erlotinib hydrochloride
* No poorly controlled diabetes mellitus
* Patients with a history of diabetes mellitus are eligible, provided their blood glucose is within normal range at screening and they are on a stable dietary or therapeutic regimen for this condition
* No uncontrolled intercurrent illness including, but not limited to, any of the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness or social situation that would limit compliance with study requirements
* No inability to take oral medications or, in the investigator's opinion, gastrointestinal conditions or abnormalities likely to influence the absorption of oral medications
* No prior or concurrent exposure to other EGFR or IGFR inhibitors
* Recovered from all prior therapy with acute effects resolved to ≤ grade 1
* At least 28 days since prior anticancer or investigational agent (within predicted 5 half-lives of agent)
* More than 4 weeks since prior radiotherapy to target lesions and documented disease progression at these sites
* More than 2 weeks since prior radiotherapy to non-target lesions
* More than 4 months since prior major surgery or hormonal therapy (other than replacement)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00778167
Study Brief:
Protocol Section:
NCT00778167