Local Therapies for Oligometastatic Non-Small Cell Lung Cancer Harboring Sensitizing EGFR Mutations

Conditions

• Oligometastatic Lung Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Erlotinib — DRUG
• Local Therapies — OTHER
  Definitive local therapies include surgical resection, stereotactic radiosurgery, ablation and conventional radiation therapy

Study Details

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.

Key Dates

First listed

May 21, 2015

Start date

May 14, 2015

Status verified

Dec 2017

Primary completion

Dec 11, 2017

Completion

Dec 11, 2017

Study Design

Enrollment

4 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Oligometastatic Non-Small Cell Lung Cancer
  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.

Primary Outcome Measure

Feasibility as Measured by at Least Five Patients Will Need to Complete Local Therapy. [ Time Frame: 2 years ]

Locations (7)

Find similar trials in Basking Ridge, NJ