Patients who have a histologically or cytologically documented diagnosis of nonsquamous stage IIIB or stage IV NSCLC that is not amenable to curative therapy. MedDRA version: 9.1 Level: LLT Classification code 10025054 Term: Lung cancer non-small cell stage IIIB MedDRA version: 9.1 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV
Conditions
Interventions
Trade Name: Alimta
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: pemetrexed
CAS Number: 150399-23-8
Current Sponsor code: LY231514
Concentration unit: mg m
Sponsors
Eli Lilly and Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV NSCLC that is not amenable to curative therapy. See Protocol Attachment S125.2, American Joint Committee on Cancer Staging Criteria for Lung Cancer; Greene et al. 2002. [2] ECOG PS of 0 or 1 (Oken et al. 1982) (see Protocol Attachment S125.3). [3] Patients with prior radiation therapy may be eligible for this study if they meet the following guidelines: • Previous radiation therapy is allowed if it was to =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: [11] Have received prior systemic anticancer therapy for lung cancer (including adjuvant early-stage treatment for NSCLC). [12] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. [13] Have a serious concomitant systemic disorder (for example, active infection including human immunodeficiency virus) that, in the opinion of the investigator, would compromise the patient’s ability to adhere to the protocol. [14] Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV (see Protocol Attachment S125.6). [15] Have had a prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. Patients with a history of low-grade (Gleason score ?6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously. [16] Have a second primary malignancy that is clinically detectable at the time of consideration for study enrollment. [17] Have central nervous system (CNS) metastases. Brain imaging is required in symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients. [18] Are receiving concurrent administration of any other antitumor therapy. [19] Are taking or have recently taken (within 10 days of enrollment) aspirin (>325 mg/d), clopidogrel at doses >75 mg/d, dipyramidole, ticlopidine, or cliostazol. Patients are also excluded if they cannot hold nonsteroidal anti-inflammatory agents, other than prophylactic therapy with low-dose aspirin, for a 5-day period during each cycle (8 day period for long-acting agents, such as piroxicam) (see Section 5.7.6 for details). [20] Are unable or unwilling to take folic acid or vitamin B12 supplementation. [21] Are unable or unwilling to take corticosteroids. [22] Have a history of gastrointestinal fistula, perforation, or abscess, inflammatory bowel disease, or diverticulitis. [23] Have clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry. [24] Have had significant weight loss (that is, ?10%) over the previous 6 weeks before study entry. [25] Have a history of gross hemoptysis (bright red blood of ?½ teaspoon per episode of coughing) <3 months prior to enrollment or history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding. [26] Are taking or have recently taken (within 10 days of enrollment) full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes. Prophylactic use of anticoagulants is allowed; international normalized ratio (INR) should be <1.5 at study enrollment. [27] Have a history of hypertension, unless hypertension is well controlled upon study entry (?150/90 mm Hg) and the patient is on a stable regimen of antihypertensive therapy. Patients should not have any prior history of hypertensive crisis or hypertensive encephalopathy. [28] Have had major surgery, open biopsy, or significant traumatic injury within 28 days prior to study enrollment, or anticipate the need for major surgical procedure during the course of the study. [29] Have a history o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this Phase 2 study is to assess the efficacy of pemetrexed-cisplatin combined with bevacizumab as induction therapy and pemetrexed-bevacizumab as maintenance therapy in the first-line treatment of patients with Stage IIIB or IV nonsquamous NSCLC, as measured by PFS.;Secondary Objective: •Overall survival (OS) •Overall response rate (ORR) •Safety and tolerability ;Primary end point(s): progression free survival | — |
Countries
Denmark, Germany, Italy, Spain, Sweden
Outcome results
None listed