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:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT00003869
Eligibility Criteria:
Inclusion Criteria:
* TRACK I: Histologically or cytologically confirmed NSCLC stage III or IV; disease must be stable or responding after standard chemotherapy (with or without TRT) for a minimum of 3 or a maximum of 6 months
* TRACK I: Not required to have measurable or evaluable disease at study entry
* TRACK I: Must have had one and only one prior chemotherapy regimen for NSCLC (radiosensitizers are allowed)
* TRACK I: =\< 6 weeks from last dose of chemotherapy or TRT
* TRACK I: ECOG PS 0, 1, or 2
* TRACK I: ANC \>= 1500/mm\^3
* TRACK I: PLT \>= 100,000/mm\^3
* TRACK I: HgB \>= 10.0 g/dL
* TRACK I: Total bilirubin =\< 1.5 x UNL
* TRACK I: Alkaline phosphatase =\< 3 x UNL
* TRACK I: AST =\< 3 x UNL
* TRACK I: Creatinine =\< 1.5 x UNL
* TRACK I: Expected survival of at least three months
* TRACK II AT REGISTRATION: Histologically or cytologically confirmed NSCLC stage III or IV
* TRACK II AT REGISTRATION: No prior chemotherapy for NSCLC
* TRACK II AT REGISTRATION: Expected survival of at least six months
* TRACK II AT REGISTRATION: Willingness to provide blood sample
* TRACK II AT RANDOMIZATION: STAB, PR, CR, REGR following 3-6 months of chemotherapy with or without radiation therapy
* TRACK II AT RANDOMIZATION: Must have had one and only one prior chemotherapy regimen for NSCLC (radiosensitizers are allowed)
* TRACK II AT RANDOMIZATION: =\< 6 weeks from last dose of chemotherapy or TRT
* TRACK II AT RANDOMIZATION: ECOG PS 0, 1, or 2
* TRACK II AT RANDOMIZATION: ANC \>= 1500/mm\^3
* TRACK II AT RANDOMIZATION: PLT \>= 100,000/mm\^3
* TRACK II AT RANDOMIZATION: HgB \>= 10.0 g/dL
* TRACK II AT RANDOMIZATION: Total bilirubin =\< 1.5 x UNL
* TRACK II AT RANDOMIZATION: Alkaline phosphatase =\< 3 x UNL
* TRACK II AT RANDOMIZATION: AST =\< 3 x UNL
* TRACK II AT RANDOMIZATION: Creatinine =\< 1.5 x UNL
* TRACK II AT RANDOMIZATION: Expected survival of at least three months
Exclusion Criteria:
* TRACK I: Pregnant, nursing women, females or sexual partners of childbearing potential not using adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], or abstinence, etc.) while on study treatment and for two months after discontinuing study treatment as this regimen may be harmful to a developing fetus or nursing child
* TRACK I: Untreated brain metastases
* TRACK I: Concomitant participation in a phase III lung cancer treatment trial
* TRACK I: Planned concurrent chemotherapy, immunotherapy or radiotherapy
* TRACK II AT RANDOMIZATION: Pregnant, nursing women, females or sexual partners of childbearing potential not using adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], or abstinence, etc.) while on study treatment and for two months after discontinuing study treatment as this regimen may be harmful to a developing fetus or nursing child
* TRACK II AT RANDOMIZATION: Untreated brain metastases
* TRACK II AT RANDOMIZATION: Planned concurrent chemotherapy, immunotherapy, or radiotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00003869
Study Brief:
Protocol Section:
NCT00003869