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Comparing Second-Line Therapies for Advanced Lung Cancer
Untitled Document
Name of the Trial
Phase III Randomized Study of Pemetrexed Disodium Versus Erlotinib Hydrochloride
As Second-Line Therapy in Patients with Advanced Non-Small Cell Lung Cancer
(NCCTG-N0723). See the protocol
summary.
Principal Investigators
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Dr. Alex Adjei
Principal Investigator |
Dr. Alex Adjei, NCCTG; Dr. Martin Edelman, CALGB; Dr. David Carbone, ECOG;
Dr. Fred Hirsch, SWOG; and Dr. Geoffrey Liu, NCIC-CTG
Why This Trial Is Important
Advanced non-small
cell lung cancer (NSCLC) remains a very difficult disease to treat,
with most patients dying within a few years. Nevertheless, some advances in
treatment are occurring. The chemotherapy drug pemetrexed
can prolong survival in some patients and is a standard second-line treatment
for patients with progressive or recurrent NSCLC following initial chemotherapy.
The targeted drug erlotinib
has also helped some patients with advanced NSCLC live longer and is FDA-approved
for this use.
Erlotinib targets a protein called EGFR, which is found in
abundance in some
cancers and is thought to promote cancer cell growth. In contrast, pemetrexed
inhibits cancer cell growth by interfering with DNA synthesis.
Some researchers have proposed that patients who have extra copies of the gene
that makes EGFR (a phenomenon known as EGFR gene
amplification) may be more
likely to benefit from erlotinib than patients without such gene amplification.
The only way to determine this for certain, though, is to carry out a randomized
clinical trial comparing the effects of erlotinib with those of a standard drug
in patients with and without EGFR gene amplification.
In this trial, patients with advanced NSCLC that has recurred or progressed
after initial chemotherapy will be tested for EGFR amplification and then randomly
assigned to receive either pemetrexed or erlotinib. Doctors want to see if patients
with amplified EGFR fare better on erlotinib and whether those without amplified
EGFR genes benefit more from pemetrexed. They will also measure the levels of
other potential biomarkers of
response to treatment, such as mutations in EGFR
and in another gene, KRAS, and try to correlate them with response to these
drugs.
"We're comparing two medications already approved and proven effective
as second-line therapy for lung cancer, but what we want to know is: Can we
tell by looking at the biomarkers whether one drug is better than the other
for certain patients?" said Dr. Adjei.
"Until now, the way we've treated lung cancer is blindly," he added.
"This is the first time we've had an opportunity to see if a test can help
us tailor specific therapies for specific patients. Studies like this are absolutely
crucial if we are to achieve the promise of personalized
medicine for cancer
care."
For More Information
See the lists of entry
criteria and trial
contact information or call the NCI's Cancer Information Service at 1-800-4-CANCER
(1-800-422-6237). The toll-free call is confidential.
See the Special
Report from October 2008 for more about the gene testing in this trial.
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