Modulation of Autophagy With Hydroxychloroquine in Patients With Advanced/Recurrent Non-small Cell Lung Cancer - a Phase II Study. A Study of The Cancer Institute of New Jersey Oncology Group (CINJOG)
A patient is eligible for enrollment if all of the following inclusion criteria are met:
- Signed a protocol-specific informed consent.
- 18 years of age or older.
- ECOG Performance Status 0 or 1. (see Appendix A)
- Histologically or cytologically confirmed non-small cell lung cancer. Mixed tumors
will be categorized by the predominant cell type unless small cell elements are
present, in which case the patient is ineligible. Cytologic or histologic elements
can be established on metastatic tumor aspirate or biopsy. Sputum cytology alone is
- Advanced stage NSCLC (stage IVa ((malignant pleural effusion (is now staged as stage
IVa by the most recent staging system), or stage IV, or recurrent disease)).
- Measurable disease according to RECIST criteria.
- Patient with CNS metastasis are required to have stable disease documented by being
off treatment (surgery, radiation therapy) for at least 2 weeks, and four (4) weeks
is preferred. A contrast enhanced brain CT or brain MRI is required within 35 days
of enrollment. Patients with brain metastases who qualify for protocol therapy will
be included in Cohort 2 (ineligible for treatment with Bevacizumab).
- No prior cytotoxic chemotherapy or targeted therapy in the advanced or metastatic
setting. Post-operative adjuvant therapy for previously resected NSCLC is allowed as
long as the last dose was given greater than 1 year before study entry, and there is
current evidence of disease progression.
- Prior radiation to sites other than the brain is allowed, if completed at least 2
weeks before treatment and provided that all radiation-related toxicities have
resolved to ≤ Grade 1.
- No active malignancy other than NSCLC. Patients with a history of basal cell or
squamous cell carcinoma of the skin or carcinoma in situ of the cervix, or ductal or
lobular carcinoma in situ of the breast within the past 3 years must have been
treated with curative intent. Patients with a history of prior malignancy are
eligible provided they were treated with curative intent and have been free of
disease for > 3 years.