Phase II Trial of Carboplatin and Pemetrexed +/- OGX-427 in Untreated Stage IV Non-Squamous-Non-Small-Cell Lung Cancer (Spruce)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by SCRI Development Innovations, LLC
Sponsor:
Collaborator:
OncoGenex Pharmaceuticals
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT01829113
First received: April 8, 2013
Last updated: August 27, 2014
Last verified: August 2014

April 8, 2013
August 27, 2014
July 2013
October 2015   (final data collection date for primary outcome measure)
Progression-Free Survival [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
To determine whether OGX-427 plus carboplatin/pemetrexed therapy shows a progression-free survival advantage versus carboplatin/pemetrexed
Progression-Free Survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
To determine whether OGX-427 plus carboplatin/pemetrexed therapy shows a progression-free survival advantage versus carboplatin/pemetrexed
Complete list of historical versions of study NCT01829113 on ClinicalTrials.gov Archive Site
  • Overall Response Rate [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
    To compare overall response rate in each treatment arm
  • Safety of the regimen [ Time Frame: Continuous review ] [ Designated as safety issue: Yes ]
    To compare the safety/toxicity of the combination of OGX-427 with carboplatin/pemetrexed versus placebo with carboplatin/pemetrexed. Treatment related toxicities will be assessed using Common Terminology Criteria for Adverse Events v4.0
  • Overall Survival [ Time Frame: Time from randomization until death ] [ Designated as safety issue: No ]
    To compare overall survival in each treatment arm
  • Overall Response Rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To compare overall response rate in each treatment arm
  • Overall Survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To compare overall survival in each treatment arm
  • Safety of the regimen [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    To compare the safety/toxicity of the combination of OGX-427 with carboplatin/pemetrexed versus placebo with carboplatin/pemetrexed. Treatment related toxicities will be assessed using Common Terminology Criteria for Adverse Events v4.0
  • Serum levels of Hsp27 [ Time Frame: Every cycle (3 weeks) ] [ Designated as safety issue: No ]
    To evaluate the effect of treatment with OGX-427 on serum Hsp27 levels
  • Biomarkers in Archival Tissue [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    To evaluate the correlation of biomarkers from archived tissue samples with clinical outcomes by assessing protein expression and a panel of genes utilizing an assay
  • Serum levels of Hsp27 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To evaluate the effect of treatment with OGX-427 on serum Hsp27 levels
  • Biomarkers in Archival Tissue [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To evaluate the correlation of biomarkers from archived tissue samples with clinical outcomes by assessing protein expression and a panel of genes utilizing an assay
 
Phase II Trial of Carboplatin and Pemetrexed +/- OGX-427 in Untreated Stage IV Non-Squamous-Non-Small-Cell Lung Cancer
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Non Squamous Non Small Cell Lung Cancer
  • Drug: 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.

  • Drug: 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.

  • Experimental: 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. 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.
    Intervention: Drug: OGX-427
  • Placebo Comparator: 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. 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
155
March 2016
October 2015   (final data collection date for primary outcome measure)

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. Recurrent or Stage IV disease (according to American Joint Committee on Cancer (AJCC) staging system, v7.0).
  3. No prior systemic chemotherapy, immunotherapy, targeted therapy, or biological therapy; adjuvant therapy is allowed as long as the interval from end of adjuvant therapy until disease progression was >12 months.
  4. No prior radiation therapy to the whole pelvis or to ≥25% of the total bone marrow area. Radiation therapy must be completed at least 2 weeks prior to randomization. Must have recovered from acute adverse effects prior to randomization.
  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 (PS) 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 (>350%) 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.
Both
18 Years and older
No
Contact: Sarah Cannon Research Institute (SCRI) 877-691-7274 asksarah@scresearch.net
United States
 
NCT01829113
SCRI LUN 229
No
SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
OncoGenex Pharmaceuticals
Study Chair: David R. Spigel, M.D. SCRI
SCRI Development Innovations, LLC
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP