Overview

This trial is active, not recruiting.

Condition non squamous non small cell lung cancer
Treatments ogx-427, placebo
Phase phase 2
Sponsor SCRI Development Innovations, LLC
Collaborator OncoGenex Technologies
Start date July 2013
End date September 2015
Trial size 155 participants
Trial identifier NCT01829113, SCRI LUN 229

Summary

This randomized phase II study will compare the efficacy and safety of the combination of carboplatin and pemetrexed with and without OGX-427 in patients with previously untreated advanced non-squamous NSCLC.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Three loading doses of OGX-427 at 600mg IV will be administered Days -9 to -1. Following the loading dose period, OGX-427 will be administered at 600mg IV weekly Days 1, 8 and 15 of each 21 day cycle during the Treatment Phase. The Treatment Phase will be followed by a Maintenance Phase of OGX-427 administered at 600mg IV weekly Days 1, 8 and 15 of each 21 day cycle.
ogx-427
Three loading doses of OGX-427 at 600mg IV will be administered Days -9 to -1. Following the loading dose period, OGX-427 will be administered at 600mg IV weekly Days 1, 8 and 15 of each 21 day cycle during the Treatment Phase. OGX-427 will be given prior to the administration of pemetrexed (500mg/m2 IV) and carboplatin (AUC 6 IV) on Day 1 of each cycle. A maximum of four treatment cycles will be administered. Patients with objective response or stable disease after four cycles of therapy will move on to a Maintenance Phase of OGX-427 administered at 600mg IV weekly Days 1, 8 and 15 of each 21 day cycle plus pemetrexed (500mg/m2 IV on Day 1). Patients may remain on maintenance as long as they are benefiting and have no evidence of disease progression.
(Placebo Comparator)
Three loading doses of placebo will be administered IV Days -9 to -1. Following the loading dose period, placebo will be administered IV weekly Days 1, 8 and 15 of each 21 day cycle during the Treatment Phase. The Treatment Phase will be followed by a Maintenance Phase of placebo administered IV weekly Days 1, 8 and 15 of each 21 day cycle.
placebo
Three loading doses of placebo will be administered IV Days -9 to -1. Following the loading dose period, placebo will be administered IV weekly Days 1, 8 and 15 of each 21 day cycle during the Treatment Phase. Placebo will be given prior to the administration of pemetrexed (500mg/m2 IV) and carboplatin (AUC 6 IV) on Day 1 of each cycle. A maximum of four treatment cycles will be administered. Patients with objective response or stable disease after four cycles of therapy will move on to a Maintenance Phase of placebo administered IV weekly Days 1, 8 and 15 of each 21 day cycle plus pemetrexed (500mg/m2 IV on Day 1). Patients may remain on maintenance as long as they are benefiting and have no evidence of disease progression.

Primary Outcomes

Measure
Progression-Free Survival
time frame: Every 6 weeks

Secondary Outcomes

Measure
Overall Response Rate
time frame: Every 6 weeks, projected 32 months.
Safety of the regimen
time frame: Continuous review
Overall Survival
time frame: Every 6 weeks, projected 32 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Histologic or cytologic diagnosis of advanced NSCLC, excluding squamous cell and small cell histology. Tumors with mixed NSCLC histologies are eligible, as long as the predominant histology is not squamous. If small-cell elements are present or not otherwise specified histologically, the patient is not eligible. 2. Metastatic disease (according to American Joint Committee on Cancer (AJCC) staging system, v7.0). 3. No prior systemic chemotherapy, immunotherapy, targeted therapy, or biological therapy for metastatic disease; adjuvant or neoadjuvant therapy for Stage I, II, or III disease is allowed as long as the interval from the end of treatment until disease progression was >12 months. 4. No prior radiation therapy to the whole pelvis or to ≥25% of the total bone marrow area. Other radiation therapy must be completed at least 2 weeks prior to study entry. Must have recovered from acute adverse effects prior to study entry. 5. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 6. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. 7. Baseline laboratory values as follows: - Absolute neutrophil count (ANC) ≥1500/μL - Hemoglobin (Hgb) ≥10 g/dL - Platelets ≥100,000/μL - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST), ≤3.0 x the upper limit of normal (ULN); 5 x ULN if known hepatic metastases. - Total bilirubin ≤1.5 x ULN, unless secondary to Gilbert's disease - Serum creatinine ≤1.5 x ULN. If creatinine is >1.5, calculate creatinine clearance (CrCl) ≥45 mL/min by the Cockcroft-Gault method: Glomerular Filtration Rate (GFR) = (140-age) x (weight/kg) x (0.85 if female)/ (72 x serum creatinine mg/dL) 8. Fertile male patients willing to use adequate contraceptive measures. 9. Female patients who are not of child-bearing potential, and fertile female patients of child-bearing potential who agree to use adequate contraceptive measures, who are not breastfeeding, and who have a negative serum or urine pregnancy test within 72 hours prior to start of randomization. 10. Life expectancy ≥ 12 weeks. 11. Must be ≥18 years of age at the time of consent. 12. Willingness and ability to comply with trial and follow-up procedures. 13. Ability to understand the nature of this trial and give written informed consent. Exclusion Criteria: 1. Known anaplastic lymphoma kinase (ALK) translocation and epidermal growth factor receptor (EGFR) "activating" mutations where first-line treatment with targeted tyrosine kinase inhibitor therapy is more appropriate. 2. Known central nervous system (CNS) disease other than neurologically stable, treated brain metastases defined as metastasis having no evidence of progression or hemorrhage after treatment and no ongoing requirements for corticosteroids, (e.g., dexamethasone) for at least 2 weeks. 3. Any of the following cardiac diseases currently or within the last 6 months as defined by New York Heart Association (NYHA) ≥ Class 2: - Unstable angina pectoris - Congestive heart failure - Acute myocardial infarction - Conduction abnormality not controlled with pacemaker or medication - Significant ventricular or supraventricular arrhythmias (Patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible). 4. Patients currently receiving therapeutic anticoagulation. 5. Pregnant or lactating women. 6. Any serious, active underlying medical condition that would impair the ability of the patient to receive study treatment, such as diabetes mellitus or infection. 7. Unable or unwilling to take folic acid or vitamin B12. 8. Active second malignancy (except non-melanomatous skin or superficial bladder cancer) defined as requiring current need for cancer therapy or at high risk of recurrence during the study. 9. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol. 10. Inability or unwillingness to comply with trial and/or follow-up procedures outlined in the protocol.

Additional Information

Official title Double-Blind Randomized Phase II Trial of Carboplatin and Pemetrexed With or Without OGX-427 in Patients With Previously Untreated Stage IV Non-Squamous-Non-Small-Cell Lung Cancer (The Spruce Clinical Trial)
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by SCRI Development Innovations, LLC.