Details
Description
Inclusion Criteria
Exclusion Criteria
Details
Title LCCC 1123: Phase II Study of Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib for Patients with EGFR Mutation Who Have Previously Progressed on an EGFR-TKI
IRB UNC 1512
CC 12-1096
Hospital Main Campus
Stage Stage 4
Phase Phase 2
Disease Lung
Drug Erlotinib
Description
- Primary
- To estimate PFS after locally ablative therapy and erlotinib in EGFR-mutant NSCLC patients who progressed on prior EGFR-TKI therapy
- Secondary
- To evaluate local control of sites previously progressive on erlotinib following SRS followed by erlotinib
- To estimate OS after locally ablative therapy and erlotinib in EGFR-mutant NSCLC patients who progressed on prior EGFR-TKI therapy
- To characterize the toxicity of SRS
- To characterize the toxicity of erlotinib when preceded by SRS
Inclusion Criteria
- Written informed consent has been obtained.
- ≥18 years of age
- Histologically or cytologically confirmed stage IV EGFR-mutant NSCLC or, in the absence of availability of EGFR testing (for example, inadequate tissue), clinical response overwhelmingly consistent with EGFR mutation (PR plus at least 6 months free of progressive disease as a consequence of EGFR-TKI therapy).
- History of previous response to EGFR-TKI, defined as either a PR by RECIST1.1 criteria, or at least six months without progressive disease as a result of EGFR-TKI therapy
- Progressive disease as measured via RECIST1.1 following EGFR-TKI therapy (with ≤5 sites of disease amenable to SRS or other locally-ablative treatment)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate organ and marrow function as defined below:
- Absolute neutrophil count [ANC] ≥ 1,500 cells/μL
- Hemoglobin ≥ 10 g/dL
- Platelets ≥ 100,000/μL
- Serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min
- Total bilirubin ≤ 3.0 x upper limit of normal [ULN]
- Alanine aminotransferase [ALT] ≤ 2.5 x ULN
- Aspartate aminotransferase [AST] ≤ 2.5 x ULN
- Female patients must have a negative urine or serum pregnancy test at screening(pregnancy test not required for patients with bilateral oophorectomy and/or hysterectomy or for those patients who are > 1 year postmenopausal).
- All patients of reproductive potential must agree to use adequate contraception
Exclusion Criteria
- Any unresolved chronic toxicities > grade 2, measured by CTCAE v4.
- Treatment with any FDA approved or experimental cancer treatment following progression on EGFR-TKI (e.g., radiation or chemotherapy; supportive regimens such as denosumab or zoledronic acid will not result in exclusion)
- Any history of previous ≥ grade 3 toxicity attributable to erlotinib (except dermatological toxicity)
- Pregnant or lactating female
- Any previous radiation to sites of planned SRS. A patient may be deemed eligible in this case if a non-radiation mode of local ablation such as surgical resection is deemed safe and feasible by the PI.
- History of another malignancy; exception: Subjects who have been disease-free for 3 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
- Concomitant anticancer therapy, immunotherapy, or radiation therapy (no radiation within prior 4 weeks).
- Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal, or cardiac disease)
- Known hypersensitivity reaction or idiosyncrasy to erlotinib
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
- Any other concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol