Trials Sponsors Conditions Drugs Pricing

Conditions

Oligometastatic Lung Adenocarcinoma

Keywords

Sensitizing EGFR MutationsErlotinibSurgeryRadiation Therapy15-067

Outcome Measures

Primary Outcomes (1)

Feasibility as Measured by at Least Five Patients Will Need to Complete Local Therapy.
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.
2 years

Study Arms (1)

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.

Drug: ErlotinibOther: Local Therapies

Interventions

ErlotinibDrug

Oligometastatic Non-Small Cell Lung Cancer

Local TherapiesOther

Definitive local therapies include surgical resection, stereotactic radiosurgery, ablation and conventional radiation therapy

Oligometastatic Non-Small Cell Lung Cancer

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

Memorial Sloan Kettering Cancer Center
Otherlead

Study Sites (7)

Memoral Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Memorial Sloan Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Memorial Sloan Kettering at Mercy Medical Center

Rockville Centre, New York, United States

Memoral Sloan Kettering Cancer Center at Phelps

MeSH Terms

Interventions

Erlotinib Hydrochloride

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title: Dr. Helena Yu, MD
Organization: Memorial Sloan Kettering Cancer Center

Study Officials

Helena Yu, MD
Memorial Sloan Kettering Cancer Center
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

4 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 14, 2015

First Posted

May 21, 2015

Study Start

May 14, 2015

Actual (reported)

Primary Completion

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Oligometastatic Non-Small Cell Lung Cancer

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Oligometastatic Non-Small Cell Lung Cancer

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations