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Treating Lung Cancer in Nonsmokers and Former Light Smokers
Untitled Document
Name of the Trial
Phase II Randomized Study of Erlotinib With or Without Carboplatin and Paclitaxel
in Patients With Chemotherapy-Naïve Select Stage IIIB or Stage IV Non-Small
Cell Lung Cancer (CALGB-30406). See the protocol
summary.
Principal Investigators
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Dr. Pasi Janne
Principal Investigator |
Dr. Pasi Janne and Dr. Vincent Miller, Cancer and Leukemia Group B.
Why This Trial Is Important
The drug erlotinib (Tarceva) is approved to treat non-small cell lung cancer
(NSCLC) that has not responded to chemotherapy (that is, as second-line therapy).
However, the patients who benefited the most from erlotinib in the trial that
led to its approval were those who had never smoked. Subsequent research has
shown that "never smokers" have improved outcomes when treated with
erlotinib because their cancers have specific mutations in a protein called
epidermal growth factor receptor (EGFR), which is the target of erlotinib. In
the presence of such mutations, erlotinib is particularly effective. It is important
for the management of these patients, however, to compare the benefits of erlotinib
alone or in combination with chemotherapy in first-line treatment.
In this trial, previously untreated NSCLC patients who never smoked or are
former light smokers will be treated with either erlotinib alone or erlotinib
in combination with the drugs carboplatin and paclitaxel.
"Lung cancer in nonsmokers is really a different disease than lung cancer
in smokers," said Dr. Janne. "Nonsmokers are much more likely to have
activating mutations in EGFR, and erlotinib seems to be effective in patients
with such mutations.
"We hope to show that erlotinib, either given alone or in combination
with chemotherapy, is useful as a first-line therapy for these patients,"
Dr. Janne commented.
Who Can Join This Trial
Researchers will enroll 180 patients with select stage IIIB or stage IV NSCLC
who are either nonsmokers or former light smokers and have not received prior
chemotherapy. See the list
of eligibility criteria.
Study Sites and Contact Information
Study sites in the United States are recruiting patients for this trial. See
the list
of study contacts or call the NCI's Cancer Information Service at 1-800-4-CANCER
(1-800-422-6237) for more information. The toll-free call is confidential.
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