NCT00547105

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

Completed Phase 2 Results posted Last updated 21 August 2020

What this trial tests

Phase 2 trial testing Erlotinib in Lung Cancer in 24 participants. Completed in 6 July 2017.

Timeline

25 June 2007

Primary endpoint
6 July 2016

6 July 2017

Quick facts

Lead sponsor	University of Texas Southwestern Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	25 June 2007
Primary completion	6 July 2016
Estimated completion	6 July 2017
Sites	2 locations across United States

Drugs / interventions tested

• Erlotinib (erlotinib) — full drug profile →
• SBRT — full drug profile →

Conditions studied

• Lung Cancer — all drugs for Lung Cancer →

Sponsor

University of Texas Southwestern Medical Center

Who can join

Adults 18 to 120, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

6 Month Progression-Free Survival Primary · 6 months

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

Group	Value	95% CI
SBRT Combined With Erlotinib	69

In-field Local Control Secondary · 9 months

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

Group	Value	95% CI
SBRT Combined With Erlotinib	44

Number of Participants Without Serious Adverse Events Related to Radiation Secondary · 3 years

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

Group	Value	95% CI
SBRT Combined With Erlotinib	22

Overall Survival Secondary · up to 5 years

evaluate overall survival after SBRT in combination with erlotinib

Group	Value	95% CI
SBRT Combined With Erlotinib	20.4	3 – 60

Duration of Erlotinib Use and Time to Initiation of Third-line Systemic Therapy Secondary · 3 years

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

Group	Value	95% CI
SBRT Combined With Erlotinib	183	24 – 847

Out-of-field Disease Progression Secondary · 9 months

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

Group	Value	95% CI
SBRT Combined With Erlotinib	10

Progression-free Survival Secondary · 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

Group	Value	95% CI
SBRT Combined With Erlotinib	14.7	2 – 60

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SBRT Combined With Erlotinib

Serious: 5/24 (21%)

Deaths: 13/24

Serious adverse events (3 terms)

Reaction	System	SBRT Combined With Erlotinib
diarrhea grade 4	Gastrointestinal disorders	—
Pneumonitis grade 3	Respiratory, thoracic and mediastinal disorders	—
spinal fraction grade 3	Injury, poisoning and procedural complications	—

Most-reported serious reactions: diarrhea grade 4, Pneumonitis grade 3, spinal fraction grade 3.

Data from ClinicalTrials.gov NCT00547105 adverse events section.

Sponsor's own description

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving erlotinib together with stereotactic body radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving erlotinib together with stereotactic body radiation therapy works in treating patients with locally advanced or metastatic non-small cell lung cancer.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Integration of immunogenic cell death in the treatment landscape of non-small cell lung cancer: harnessing the power of the immune system.
   Liu Z, Xu X, Wang M, Zhang J, et al · · 2026 · PMID 41851096 · DOI 10.1038/s41420-026-03012-2