Trial Outcomes & Findings for Erlotinib and SBRT in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NCT NCT00547105)

Results Overview

For liver lesions treated with SBRT, RECIST (Response Evaluation Criteria in Solid Tumors) criteria will be used for evaluation of progression. Progression (PD) is at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Evaluation of lung lesions at any time after SBRT is difficult in view of the expected fibrotic reaction. Bone lesions seen only on PET are also not well scored by RECIST criteria and will not be evaluated in that manner. In this study progressive disease (PD) will be defined as residual increased metabolic PET scan in combination with expanded parenchymal opacity that retains mass-like discrete borders and extends outside the volume of lung that received at least 18 Gy.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

6 months

Results posted on

2020-08-21

Participant Flow

Participant milestones

Participant milestones
Measure	Stereotactic Body Radiation Therapy Combined With Erlotinib Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). Stereotactic Body Radiation Therapy (SBRT) will commence within 4 weeks of the initiation of erlotinib Erlotinib: Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. SBRT: SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Erlotinib and SBRT in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SBRT in Combination With Erlotinib n=24 Participants Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib Erlotinib: Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. SBRT: SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Twenty-four patients with stage IV Non-small-Cell Lung Caner with six or fewer sites of disease after progressing through first-line or subsequent systemic therapy were enrolled on the study.

For liver lesions treated with SBRT, RECIST (Response Evaluation Criteria in Solid Tumors) criteria will be used for evaluation of progression. Progression (PD) is at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Evaluation of lung lesions at any time after SBRT is difficult in view of the expected fibrotic reaction. Bone lesions seen only on PET are also not well scored by RECIST criteria and will not be evaluated in that manner. In this study progressive disease (PD) will be defined as residual increased metabolic PET scan in combination with expanded parenchymal opacity that retains mass-like discrete borders and extends outside the volume of lung that received at least 18 Gy.

Outcome measures

Outcome measures
Measure	SBRT Combined With Erlotinib n=24 Participants Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib Erlotinib: Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. SBRT: SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body
6 Month Progression-Free Survival	69 percentage of participants

SECONDARY outcome

Timeframe: 9 months

Population: 21 out of 24 patients were evaluable with baseline and minimum 3-month follow-up CT based imaging. The other three patients died or had not otherwise reached this window for evaluation.

In-field local control is defined as number of treated lesions that did not grow in size or increase in metabolic activity.

Outcome measures

Outcome measures
Measure	SBRT Combined With Erlotinib n=47 lesions treated with SBRT Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib Erlotinib: Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. SBRT: SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body
In-field Local Control	44 lesions treated with SBRT

SECONDARY outcome

Timeframe: 3 years

Common Terminology Criteria for Adverse Events v4.03 (CTCAE) is used as the standard classification and severity grading scale for adverse events

Outcome measures

Outcome measures
Measure	SBRT Combined With Erlotinib n=24 Participants Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib Erlotinib: Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. SBRT: SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body
Number of Participants Without Serious Adverse Events Related to Radiation	22 Participants

SECONDARY outcome

Timeframe: up to 5 years

evaluate overall survival after SBRT in combination with erlotinib

Outcome measures

Outcome measures
Measure	SBRT Combined With Erlotinib n=24 Participants Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib Erlotinib: Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. SBRT: SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body
Overall Survival	20.4 months Interval 3.0 to 60.0

SECONDARY outcome

Timeframe: 3 years

To evaluate the duration of erlotinib usage and time to initiation of third line systemic agent (chemotherapy or biologic agent)

Outcome measures

Outcome measures
Measure	SBRT Combined With Erlotinib n=24 Participants Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib Erlotinib: Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. SBRT: SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body
Duration of Erlotinib Use and Time to Initiation of Third-line Systemic Therapy	183 days Interval 24.0 to 847.0

SECONDARY outcome

Timeframe: 9 months

Population: The other three patients died or had not otherwise reached this window for evaluation.

Number of Participants with Disease Progression Outside the Radiation treated field at 9 Months

Outcome measures

Outcome measures
Measure	SBRT Combined With Erlotinib n=21 Participants Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib Erlotinib: Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. SBRT: SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body
Out-of-field Disease Progression	10 Participants

SECONDARY outcome

Timeframe: up to 5 years

For liver lesions treated with SBRT, RECIST (Response Evaluation Criteria in Solid Tumors) criteria will be used for evaluation of progression. Progression (PD) is at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Evaluation of lung lesions at any time after SBRT is difficult in view of the expected fibrotic reaction. Bone lesions seen only on PET are also not well scored by RECIST criteria and will not be evaluated in that manner. In this study progressive disease (PD) will be defined as residual increased metabolic PET scan in combination with expanded parenchymal opacity that retains mass-like discrete borders and extends outside the volume of lung that received at least 18 Gy.

Outcome measures

Outcome measures
Measure	SBRT Combined With Erlotinib n=24 Participants Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib Erlotinib: Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. SBRT: SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body
Progression-free Survival	14.7 months Interval 2.0 to 60.0

Adverse Events

SBRT Combined With Erlotinib

Serious events: 5 serious events

Other events: 0 other events

Deaths: 13 deaths

Serious adverse events

Serious adverse events
Measure	SBRT Combined With Erlotinib n=24 participants at risk Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib Erlotinib: Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. SBRT: SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body
Respiratory, thoracic and mediastinal disorders Pneumonitis grade 3	4.2% 1/24 • Number of events 1 • 3 years
Gastrointestinal disorders diarrhea grade 4	12.5% 3/24 • Number of events 3 • 3 years
Injury, poisoning and procedural complications spinal fraction grade 3	4.2% 1/24 • Number of events 1 • 3 years

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Trial

UT Southwestern Medical Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place