Non-small cell lung cancer MedDRA version: 14.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Geron Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed informed consent. • Ability and willingness to comply with requirements of the study protocol. • Male or female, age 18 or over. • Histologically or cytologically confirmed diagnosis of NSCLC • Stage IV (using the 7th edition of AJCC, or wet IIIb / IV using the 6th edition), or recurrent locally advanced disease not amenable to radiation or surgery with curative intent, or are not amenable to concurrent chemoradiation. • Patients have completed four to six cycles of platinum-based chemotherapy doublet for first line, advanced NSCLC, with no evidence of disease progression according to RECIST version 1.1. Adjuvant chemotherapy greater than one year prior to progression is allowed. • Patients are willing and able to continue treatment with bevacizumab, if they received it with their platinum based chemotherapy. • ECOG performance status 0-1 • Adequate bone marrow reserve as measured by ANC = 1500/mm3, hemoglobin = 9 g/dL, platelet count = 75,000 µL. Must be measured = 1 week after last transfusion of blood products and/or last dose of hematopoietic growth factor. • Prothrombin Time (PT) or INR or aPTT = 1.5 x ULN. • Serum creatinine 45 mL/min. • Urinalysis with =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from screening and study entry: • Patients who are not eligible for induction therapy with a platinum based chemotherapy doublet • Patients who are scheduled to receive, or have received, pemetrexed or erlotinib as maintenance therapy. • Patients receiving bevacizumab must not have a recent history of hemoptysis = ½ teaspoon of red blood, or = 2 g/24 hr urinary protein while receiving prior bevacizumab, or squamous cell histology. Patients will be excluded from being randomized if any of the following criteria apply: • Last dose of induction chemotherapy 42 days prior to randomization • History of pulmonary hemorrhage (> 1 teaspoon) within the previous 4 weeks • Anti-platelet therapy within 2 weeks prior to first study drug administration, other than low dose aspirin prophylaxis therapy (baby aspirin). • Therapeutic anticoagulation therapy except for low dose warfarin (e.g., 1 mg by mouth per day). • Radiation therapy within 3 weeks prior to first study drug administration (palliative radiation therapy is allowed, provided that sites of bone marrow production, i.e. iliac crests are not in the radiation field). • Major surgery within 4 weeks prior to first study drug administration (central line placement is allowed) • Active central nervous system (CNS) metastatic disease. Patients with stable CNS disease following completion of radiation therapy and/or surgery are eligible. • Any other active malignancy • Active or chronically recurrent bleeding (e.g., active peptic ulcer disease) • Clinically significant infection • Active autoimmune disease requiring immunosuppressive therapy • Clinically significant cardiovascular disease or condition (listed in protocol). • Any other severe, acute, or chronic medical or psychiatric condition, laboratory abnormality, or difficulty complying with protocol requirements that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To obtain a preliminary estimate of efficacy as defined by progression-free survival for patients with advanced NSCLC who receive four to six cycles of induction chemotherapy and are randomized to receive treatment with either: - Imetelstat maintenance therapy in addition to standard of care (bevacizumab or observation); - Standard of care alone (bevacizumab or observation);Secondary Objective: To assess the safety and tolerability of imetelstat as part of maintenance therapy following initial induction chemotherapy in patients with advanced NSCLC. To obtain a preliminary estimate of the response rate when imetelstat is used as part of maintenance therapy in patients with advanced NSCLC.;Primary end point(s): Progression-free survival, defined as the time from randomization to documented disease progression, as determined by the Investigator’s assessment according to RECIST criteria (version 1.1) or death from any cause, whichever occurs first. | — |
Countries
Germany
Outcome results
None listed