None listed
Conditions
Interventions
Drug, Radiation : Concurrent Phase:
ArmA: Pemetrexed: 500 mg/m2, iv on D1, 22, and 43
Cisplatin: 75 mg/m2, iv after pemetrexed on D1,
22, and 43
TRT: 66 Gy in 33 fractions (daily 2 Gy fx
Mon-Fri)
Folic Acid: 350-1000 µg.
Vitamin B12: 1000 µg, im within the week prior to the first dose of pemetrexed
repeat q9weeks thereafter
Dexamethasone: 4 mg, po BID taken the day
before, day of, and day after treatment.
ArmB: Etoposide: 50 mg/m2, iv on D1-D5, and D29-D33
Cisplatin: 50 mg/m2, iv after etoposide
Mon-Fri)
Consolidation phase:
Arm A: Pemetrexed: 500 mg/m2, iv on D1, 22, 43, and 64 Supplemented with folic acid, vitamin B12, and dexamethasone per local regulatory guideline
Arm B:
Cytotoxic chemo
Sponsors
Eli Lilly Korea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Present with histologically proven or cytological diagnosis of NSCLC that is defined as other than predominantly squamous cell histology (squamous cell and/or mixed small cell, non-small cell histology is not permitted) [2] Stage IIIA or IIIB NSCLC (without malignant pleural/pericardial effusion). The presence of pleural/pericardial fluid is presumed indicative of metastatic disease unless proven otherwise. NOTE: A pleural effusion fluid that is present on both a CT chest scan and routine chest x-ray requires a pleuracentesis to ensure the effusion is cytologically negative. Patients with effusions that are exudates are excluded even if the effusions are cytologically negative. Patients with effusions that are not visible on routine chest x-ray or are too small to be tapped safely may be entered on this study, provided the remaining inclusion/exclusion criteria are met. Sites are encouraged to obtain tissue confirmation of mediastinal nodal involvement. However, mediastinal nodal involvement can be declared present in situations where there is a mass of lymph nodes present in which the margins of these nodes are indistinct. In situations where the nodes have distinct margins, the size of the shortest axis of at least 1 node must be >=2.0 cm (CT/MRI). Cases in which the distinct nodes all have short axis of 50% of predicted normal volume and the carbon monoxide lung diffusing capacity (DLCO) >40% of predicted normal value. Patients for whom DLCO measurements are not available will be deemed to have adequate oxygen transfer if their resting capillary/arterial blood gas on room air reveals an oxygen pressure (pO2) >60 mmHg. [6] Have normal organ and marrow function, including the following: Bone marrow reserve: leukocytes >=3.0 x 109/L, absolute neutrophil count >=1.5 x 109/L, platelets >=100 x 109/L, and hemoglobin >=9 g/dL Hepatic: total bilirubin =45mL/min, based on the Cockcroft-Gault formula (Cockcroft and Gault 1976) [7] Weight loss 12 weeks [9] Age >=18 years [10] Signed informed consent from the patient [11] For women: must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for 6 months after
Exclusion criteria
Exclusion criteria: [13] Have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements [14] Have myocardial infarction within the preceding 6 months or symptomatic congestive heart failure, unstable angina pectoris, or uncontrolled cardiac arrhythmia [15] Have received treatment within the last 30 days with any other investigational agents that have not received regulatory approval for any indication at the time of study enrollment [16] Have disease considered for surgical treatment as part of their care plan, such as Pancoast or superior sulcus tumors [17] Had prior thoracic radiation. However, other prior radiotherapy is allowed. Patients must have recovered from the toxic effects of the treatment prior to study enrollment. Patients may not have received whole pelvis radiation or radiation to more than 25% of their bone marrow (Cristy and Eckermann 1987) Prior radiotherapy must have been completed at least 30 days prior to study treatment [18] Patients whose radiation treatment plans are likely to encompass a volume of whole lung receiving >=20 Gy in total (V20) of more than 35% of lung volume. In some circumstances the V20 can exceed 35% (see Section 5.2.1.1.6.7) [19] Concurrent cancer from another primary site requiring treatment of any kind within the past 5 years. Exemptions to this will be permitted on a case-bycase basis after prior approval by the lead Lilly physician or designate if the investigator believes the patient’s risk of recurrence and death is very low. Curatively treated nonmelanoma skin cancer or in situ carcinoma of any origin is allowed. Patients with recurrence of a previously resected lung cancer or who have a second primary lung cancer are ineligible. [20] Are pregnant, breast feeding, or unwilling to use adequate contraception [21] Patients with immune deficiency (for example, HIV positive) [22] Are unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose <=1.3 grams per day, for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed [23] Are unable/unwilling to take folic acid, vitamin B12, and dexamethasone [24] Have recent contraindication or rejection of the use of corticosteroids, or concomitant yellow fever vaccination (within 30 days of study enrollment) [25] Have evidence of clinical hearing loss. Patients who have hearing loss based solely on conduction deficits demonstrated on audiogram may be entered into the study. [26] Known hypersensitivity to pemetrexed, cisplatin, etoposide or any of the excipients in these medicinal products [27] Had prior systemic chemotherapy for lung cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Countries
Korea, Republic of
Contacts
Public ContactYoungWook Kim
Eli Lilly Korea
Outcome results
None listed