A Study of Erlotinib Plus Radiotherapy (RT) for Patients With Advanced or Inoperable Non-Small-Cell Lung Cancer

NCT00983307 | Completed Phase 2 Results DMC FDA Drug

• 4 other identifiers: 09G.1042008-43OSI4327sJT 1381
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief Summary

It is generally accepted that the presence of chronically hypoxic cells, or tumor cells which do not receive enough oxygen as a result of tumor growth, may be an important cause of resistance to radiation therapy (RT) and resultant tumor recurrence, particularly in large tumors such as advanced non-small-cell lung cancer (NSCLC). Therefore, delivering a higher RT dose, as is done with hypofractionated RT, to the tumor may result in higher success rate. Erlotinib (Tarceva, previously known as OSI-774) is an orally active, potent, selective inhibitor of the Epidermal Growth Factor Receptor (EGFR) tyrosine kinase. A recently completed trial has shown that Erlotinib as a single agent significantly improves the survival of patients with incurable Stage IIIb/IV NSCLC who have failed standard therapy for advanced or metastatic disease. Therefore, Erlotinib is an approved medication for second-line therapy in lung cancer following prior chemotherapy. This is a Phase II clinical research study to assess the efficacy and toxicity of hypofractionated radiation therapy in combination with Erlotinib in patients with locally advanced or inoperable non-small-cell lung cancer (NSCLC). The investigators' hypothesis is that the addition of erlotinib to RT will result in radiosensitization, therefore increasing the likelihood of local tumor control over RT alone. Maintenance erlotinib upon RT completion will result in further tumor growth inhibition, both systemically and locally, lengthening disease-free survival and overall survival.

Conditions

Carcinoma, Non-small-cell Lung

Keywords

Radiation; Erlotinib; Tarceva

Outcome Measures

Primary Outcomes (1)

• Number of Participants That Experience Progression-free Survival.

  Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

  2 years

Study Arms (1)

Erlotinib and radiotherapy

EXPERIMENTAL

Patients will be treated with Erlotinib and hypofractionated radiotherapy.

Drug: Erlotinib; Radiation: Hypofractionated Radiotherapy

Interventions

Erlotinib DRUG

Patients will receive Tarceva, 150 mg daily on days -5 through -1 days and will start a course of hypofractionated thoracic RT on Day 1. RT will be administered daily on weekdays (Monday-Friday) and not on weekends or holidays. Tarceva administration will be continued daily during RT (also on weekends/holidays when RT is not given) and after RT will be continued daily as maintenance therapy until death or disease progression.

Also known as: Erlotinib (OSI-774), Tarceva

Erlotinib and radiotherapy

Hypofractionated Radiotherapy RADIATION

Patients undergo hypofractionated thoracic RT 5 days a week for approximately 2.5 weeks beginning on day 0. Patients also receive erlotinib hydrochloride PO daily beginning on day -5 and continuing for up to 24 months in the absence of disease progression or unacceptable toxicity.

Also known as: Radiation Therapy, RT

Erlotinib and radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must fulfill all of the following criteria to be eligible for study entry:
• Patients aged 18 years or older with histologically or cytologically confirmed unresectable or medically inoperable NSCLC and measurable disease.
• Patients with AJC Stage IV (metastatic) NSCLC who need initial thoracic RT to control symptoms such as hemoptysis, airway obstruction, esophageal compression, superior vena cava syndrome, other symptoms, or to prevent symptomatic tumor progression.
• Patients with synchronous brain metastases will be allowed to enroll and to receive whole-brain radiation therapy while on the protocol.
• Patients with unresectable or medically inoperable locally advanced (AJC Stage II, IIIA or IIIB) NSCLC, who require thoracic RT but do not qualify for other protocols due to the presence of a malignant pleural or pericardial effusion, major weight loss, poor performance status, unwillingness to receive chemotherapy or other factors.
• Patients with medically inoperable Stage I NSCLC or those patients with a resectable Stage I NSCLC who decline surgery.
• Patients treated initially with systemic chemotherapy or biologic therapy who eventually develop progression of intrathoracic disease and require thoracic RT, or who may benefit from consolidative thoracic RT following chemotherapy or biologic therapy.
• Patients must have a minimal FEV1 of 1.2 l. Lower FEV1 may be allowed for small tumors and a V17 \<25%.
• Estimated life expectancy of 3 months or more.
• Patients able to provide a written informed consent prior to study entry.
• Patients who agree to have their biopsy or surgical specimen analyzed for the EGFR status.
• Women of childbearing potential must be willing to practice acceptable methods of birth control to prevent pregnancy.

You may not qualify if:

• Small cell lung cancer, any stage
• Previous thoracic radiation therapy
• Oxygen-dependent patients
• FEV1 \< 1.2 l
• Patients with severe underlying lung disease of any origin, which in the opinion of the investigators may markedly increase the risk of treatment-related pneumonitis
• Known severe hypersensitivity to Erlotinib or any of the excipients of this product
• Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St John's Wort preparations
• Treatment with a nonapproved or investigational drug within 30 days before Day 1 of trial treatment
• Incomplete healing from previous oncologic or other major surgery
• Serum creatinine level greater than CTC grade 2
• Pregnancy or breast feeding (women of childbearing potential)

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead
• Genentech, Inc.: collaborator

Study Sites (2)

Northeast Radiation Oncology Center

Dunmore, Pennsylvania, 18512, United States

Location

Thomas Jefferson Univeristy

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Thomas Jefferson University Hospitals

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Radiation Dose Hypofractionation; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dose Fractionation, Radiation; Radiotherapy Dosage; Therapeutics

Results Point of Contact

• Title: Dr. Maria Werner-Wasik
• Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University

maria.werner-wasik@jefferson.edu

215 955-6702

Study Officials

• Maria Werner-Wasik, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 24, 2009
• Study Start: August 27, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 30, 2025
• Results First Posted: January 30, 2018

Record last verified: 2025-04

Locations

US (2)