Randomized
multi-center prospective study to compare the 12-month effectiveness (survival)
and safety of Mirata
and Pemitra as maintenance treatment in two groups of patients with locally advanced or metastatic Non-Squamous Non-Small Cell
Lung Cancer (NSCLC) other than predominantly squamous cell histology, whose
disease has not progressed immediately following platinum-based chemotherapy
for 4 cycles administered per routine daily practice in the KHCC, the AUBMC,
and the KFSHRC.
Eligible patients
will be randomized into either the Erlotinib Arm, in which patients will
receive Erlotinib 150 mg once daily until disease progression or unacceptable
toxic effects, or the Pemetrexed Arm, in which patients will receive Pemetrexed
500 mg/m2 administered as an intravenous infusion over 10 minutes on
the first day of each 21-day cycle, until disease progression or unacceptable
toxicity.
Maintenance
treatment will start within 7 days from the randomization date and 21–42 days
from Day 1 of the fourth cycle of induction therapy.
All patients will be followed up until study closure or death.
1. Age ≥18 years.
2. Signed written informed consent.
3. Histologically or cytological diagnosed stage IIIB/IV non-squamous histology NSCLC.
4. Received platinum based doublet chemotherapy for 4 cycles as first line therapy before this study.
5. Patients upon enrolment has at least stable disease following the platinum doublet; with documented (confirmed or unconfirmed) radiographic evidence of a tumor response of complete response (CR), partial response (PR), or stable disease (SD) according to RECIST ver 1.1 criteria.
6. Estimated Life expectancy ≥ 3 months.
7. ECOG PS 0-2
8. Adequate organ function.
1. Age <18 years.
2. Predominantly
squamous cell and/or mixed small cell, non-small cell histology.
3. Current
treatment on another therapeutic clinical study or within the last 30 days of
entering the study.
4. Spinal
cord compression unless treated with the patient attaining good pain control
and stable or recovered neurologic function, carcinomatous meningitis, or
leptomeningeal disease.
5. Any
of the following within the 3 months prior to starting study treatment:
myocardial infarction, severe/unstable angina, coronary/peripheral artery
bypass graft, congestive heart failure, or cerebrovascular accident including
transient ischemic attack.
6. Ongoing
cardiac dysrhythmias of NCI CTCAE Grade >2, uncontrolled atrial
fibrillation of any grade, or QTc interval >470 msec.
7. Pregnancy
or breastfeeding.
8. Prior
malignancy (other than current NSCLC): patients will not be eligible if they
have evidence of active malignancy (other than non-melanoma skin cancer or
localized cervical cancer, or localized and presumed cured prostate cancer)
within the last 3 years.
9. Other
severe acute or chronic medical or psychiatric conditions, or laboratory abnormalities
that would impose, in the judgment of the investigator and/or sponsor, excessive
risk associated with study participation or study drug administration, and
which would, therefore, make the patient inappropriate to enter this study.
10. Uncontrolled
third-space fluid collections.
11. Progressive
brain metastases.
12. Hypersensitivity
to the study drugs.
13. Inability to take
corticosteroid drugs, folic acid, or vitamin B12.
14. Patients with EGFR-positive, ALK-positive (documented using FISH and/or
IHC), or unknown EGFR and ALK test results.