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First-Line Erlotinib Therapy and the Subsequent Development of Mechanisms of Secondary Resistance in Patients With Non-Small Cell Lung Cancer and Known Sensitizing EGFR Mutations


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

First-Line Erlotinib Therapy and the Subsequent Development of Mechanisms of Secondary Resistance in Patients With Non-Small Cell Lung Cancer and Known Sensitizing EGFR Mutations


- Participants will take erlotinib orally once a day. Each treatment cycle lasts 28
days.

- While on the study, participants will be required to be seen in the clinic on Day 1 of
each treatment cycle. During these visit, the following tests and procedures will be
done: physical exam and blood tests. They will also return for blood work during Cyle
1 Day 8.

- At the end of every two cycles an assessment of the participant's tumor will be done by
CT and/or MRI (this is part of regular cancer care) as well as the following: Urine
test and blood tests.

- At the end of study treatment the following procedures will be done: blood tests,
assessment of the tumor by CT and/or MRI and a new biopsy of the tumor or removal of
fluid containing tumor cells.


Inclusion Criteria:



- Histologically or cytologically confirmed non-small cell lung cancer, stage IV or
IIIB with a malignant pleural or pericardial effusion. Patients with stage I or II
non-small cell lung cancer who have undergone surgical resection but who subsequently
relapse with metastatic disease or a malignant pleural effusion are also eligible.

- Documentation of a sensitizing mutation of the epidermal growth factor receptor. In
addition, there must be a sufficient tissue for analysis of KRAS mutations and MET
amplification.

- At least one measurable or evaluable site of disease as defined by revised RECIST
(version 1.1) criteria.

- 18 years of age or older

- No more than one prior systemic therapy regimen for advanced non-small cell lung
cancer. Chemotherapy delivered as part of concurrent chemoradiation will also count
as a prior systemic therapy regimen. Adjuvant therapy for resected NSCLC will not
count towards this total as long as it was completed at least 6 months prior to
enrollment and did not include therapy with an EGFR-targeted agent. Adjuvant therapy
completed less than 6 months prior to the time of screening will count as a prior
regimen.

- 3 or more weeks since prior major surgery

- 2 or more weeks since prior radiation

- ECOG performance status 0-1

- Life expectancy > 8 weeks

- Adequate hematologic, renal, and hepatic function

- Willingness to undergo repeat tumor biopsy at the time of disease progression.

Exclusion Criteria:

- Untreated and/or uncontrolled central nervous system metastases. Patients with prior
brain metastases must have had definitive treatment (radiation or surgery) and must
be clinically stable off steroids for at least 1 week prior to enrollment.

- More than one prior systemic chemotherapy for advanced non-small cell lung cancer. ,
Chemotherapy delivered as part of concurrent chemoradiation will also count as a
prior systemic therapy regimen. Adjuvant therapy for resected NSCLC willnot count
towards this total as long as it was completed at least 6 months prior to enrollment
and did not include therapy with an EGFR-targeted agent. Adjuvant therapy completed
less than 6 months prior to the time of screening will count as a prior regimen.

- Prior exposure to erlotinib or other treatments targeting the HER family axis.

- Active malignancies within the past 3 years, except for adequately treated carcinoma
of the cervix or basal or squamous cell carcinomas of the skin.

- Any process that compromises the ability to swallow and/or absorb oral medication.

- A history of any of the following autoimmune skin disorders: Sjogren's syndrome,
scleroderma, dermatomyositis, and systemic lupus erythematosus.

- Significant medical history or unstable medical conditions.

- Concurrent use of warfarin. Patients must be off warfarin for at least one week
prior to initiation of erlotinib. Other non-warfarin anticoagulants are permitted.

- Patients who require ongoing concomitant use of one of the strong inhibitors/inducers
of CYP3A4.

- Pregnant or breastfeeding. Women of child-bearing potential must agree to use
adequate contraception prior to study entry and for the duration of study
participation.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To prospectively assess the frequency of different genetic mechanisms of secondary resistance in patients' tumors during treatment with erlotinib.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

David Jackman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

09-210

NCT ID:

NCT00997334

Start Date:

December 2009

Completion Date:

December 2014

Related Keywords:

  • Non-Small Cell Lung Cancer
  • erlotinib
  • EGFR mutation
  • NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115