Description:
This study will test if local therapies in addition to erlotinib can improve responses and delay the time until new treatment is required. This study will also collect blood samples for research blood tests.
This study will test if local therapies in addition to erlotinib can improve responses and delay the time until new treatment is required. This study will also collect blood samples for research blood tests.
Completed
N/A
| Drug | Synonyms | Arms |
|---|---|---|
| Erlotinib | Oligometastatic Non-Small Cell Lung Cancer |
| Name | Type | Description | Interventions |
|---|---|---|---|
| Oligometastatic Non-Small Cell Lung Cancer | Experimental | Patients will be placed on EGFR-TKI for their metastatic EGFR-mutant stage IV oligometastatic disease. All patients will undergo induction TKI for 12 weeks. At the conclusion of 12 weeks on erlotinib, patients without disease progression [partial response (PR) or stable disease (SD)] will undergo definitive local treatment to all remaining sites of disease. After local therapy, erlotinib will be resumed until progression of disease (POD) by RECIST criteria. All assessments completed during the 12 week TKI induction phase are to be performed per protocol with a ± 7 day window. |
|
Inclusion Criteria:
- Newly diagnosed metastatic lung adenocarcinoma (recurrent or de novo) harboring
sensitizing EGFR mutations (L858R, exon 19 deletion, G719A, L861Q, S768I, exon 19
insertions) with oligometastatic disease (≤5 discrete lesions of disease irrespective
of location, inclusive of the primary lesion):
- all sites of disease must be amenable to definitive treatment with a local therapy
(surgical resection, stereotactic radiosurgery, ablation and conventional radiation
therapy) as determined by surgery, interventional radiology and radiation oncology
- all intrathoracic lymph nodes (including hilar, mediastinal, and supraclavicular nodal
disease) are considered 1 discrete lesion.
- Each brain metastasis is included as a distinct lesion.
- Patients already started on erlotinib are eligible as long as their sites of disease
are determined to be eligible for definitive local therapy by consensus of the
principal investigators within 12 weeks of the patient first taking erlotinib.
- Lung adenocarcinoma histology confirmed at MSKCC.
- Available archived tissue to perform molecular analysis
- Patients without available archived tissue can have repeat biopsies to determine EGFR
status as per standard clinical care guidelines
- Age 18 years or older
- Karnofsky Performance Status ≥ 70%
- Adequate bone marrow, liver and renal function, as specified below:
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
- Hemoglobin ≥ 8 g/dL
- Platelets ≥ 100 x 109/L
- Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (except for patients with
documented Gilbert's Syndrome)
- AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present
- Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for
patients with creatinine levels above institutional normal.
- For women of child-bearing potential, negative pregnancy test within 14 days prior to
starting treatment
- Men and women of childbearing age must be willing to use effective contraception while
on treatment and for at least 3 months thereafter
Exclusion Criteria:
- Treatment with erlotinib prior to developing metastatic disease
- Patients with activating but not sensitizing mutations (exon 20 insertions, EGFR
T790M)
- Malignant pleural effusion or pleural disease
- Leptomeningeal disease
- Any site of disease that is not amenable to definitively local therapy including
surgery or radiation therapy
- Women who are breastfeeding or pregnant
- Concurrent malignancies other than non-melanoma skin cancer that require active
ongoing treatment.
- Any medical co-morbidities that would preclude surgery or radiation therapy
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | Feasibility as Measured by at Least Five Patients Will Need to Complete Local Therapy. |
| Time Frame: | 2 years |
| Safety Issue: | |
| Description: | At least five patients will need to complete local therapy within 2 years of the study being open to accrual for the primary endpoint to be met. |
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Completed |
| Lead Sponsor: | Memorial Sloan Kettering Cancer Center |
May 21, 2018