Phase II Trial of Erlotinib and Concurrent Palliative Thoracic Radiation Therapy for Non-small Cell Lung Cancer (PEARL)

A Phase II Trial of Erlotinib and Concurrent Palliative Thoracic Radiation Therapy for Patients With Non-small Cell Carcinoma of the Lung. (PEARL Trial)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00391248

Enrollment

Registered

2006-10-23

Start date

2006-11-30

Completion date

2012-12-31

Last updated

2013-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

non-small cell lung cancer, palliative radiation, tarceva, palliative thoracic radiation therapy

Brief summary

To improve the clinical outcomes of patients with non-small cell lung cancer treated with radiation therapy.

Interventions

DRUGErlotinib

150 mg in a single daily dose, starting Day 1 through Day 22

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically confirmed non-small cell lung cancer (squamous cell, adenocarcinoma, poorly differentiated non-small cell carcinoma, or some combination of these); and * Symptomatic patients (defined at discretion of investigator) for whom palliative thoracic radiation is planned (3000cGy/10 fractions); and * At least 18 years of age.

Exclusion criteria

* Previous erlotinib therapy; or * Planned concurrent chemotherapy; or * Expected survival of less than 3 months; or * ECOG Performance Status of 3 or 4; or * Multiple CNS metastasis or a single CNS lesion that has not demonstrated radiologic stability (screening CT/MRI or head not required); or * Granulocyte count \<1,500/mm3, platelet count \<100,000/mm3, or haemoglobin \<9.0g/dl; or * SGOT (AST) or SGPT (ALT) \> 2.5 times (x) upper limit of normal (ULN) in the absence of known liver metastases or \> 5 x ULN in case of known liver metastases; or * Alkaline phosphatase (ALP) \> 2.5 x ULN; or * Serum bilirubin \> 1.5 ULN; or * Serum creatinine \> 1.5 ULN or creatinine clearance \< 60 ml/min; or * Serum calcium beyond ULN; or * Patients requiring systemic anti-fungal therapy, clarithromycin, phenytoin, or oral anticoagulation therapy (see Appendix VI for complete list of medications); or * A history of interstitial lung disease; or * Known sensitivity to erlotinib; or * Pregnancy, lactation, or parturition within the previous 30 days; or * Unwillingness or inability to complete the required assessments of the trial; or * Mental incompetence, including psychiatric or addictive disorders which would preclude meaningful informed consent; or * History of recurrent conjunctivitis or keratitis or other inflammatory changes of the surface of the eye. * Geographically inaccessible for treatment or follow-up evaluations; or * Involved in an ongoing therapeutic trial.

Design outcomes

Primary

Measure	Time frame
The mean improvement of lung cancer symptoms as measured by the Lung Cancer Symptom Scale at four weeks following completion of radiation therapy	4 weeks post radiotherapy

Secondary

Measure	Time frame
The improvement in global quality of life and total scores of the LCSS at four weeks following treatment, radiological response, and the incidence and severity of adverse events as per the CTCAE version 3	4 weeks post radiotherapy

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026