Trial Outcomes & Findings for Local Therapies for Oligometastatic Non-Small Cell Lung Cancer Harboring Sensitizing EGFR Mutations (NCT NCT02450591)

NCT ID: NCT02450591

Last Updated: 2018-05-21

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 4 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2018-05-21

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Oligometastatic Non-Small Cell Lung Cancer n=4 Participants 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.
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Primary outcome accrual goal was not achieved. Data were not collected.

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.

Outcome measures

Outcome data not reported

Adverse Events

Oligometastatic Non-Small Cell Lung Cancer

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Measure

Oligometastatic Non-Small Cell Lung Cancer n=4 participants at risk 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.

Nervous system disorders Seizure

25.0% 1/4 • 30 days (+/- 7 days) after treatment completion

Other adverse events

Measure	Oligometastatic Non-Small Cell Lung Cancer n=4 participants at risk 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.
Skin and subcutaneous tissue disorders Rash acneiform	25.0% 1/4 • 30 days (+/- 7 days) after treatment completion
Investigations Blood bilirubin increased	25.0% 1/4 • 30 days (+/- 7 days) after treatment completion
Metabolism and nutrition disorders Hypophosphatemia	25.0% 1/4 • 30 days (+/- 7 days) after treatment completion
Eye disorders Keratitis	25.0% 1/4 • 30 days (+/- 7 days) after treatment completion

Additional Information

Dr. Helena Yu, MD

Memorial Sloan Kettering Cancer Center

Phone: 646-888-4274

Email: YuH@mskcc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place