February 2015, VOL 6, NO 1

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Clinical Trials Tracker

New Clinical Trials Under Way

The following clinical trials are currently recruiting patients with small-cell lung cancer or non–small-cell lung cancer for inclusion in several investigations.

Erlotinib With or Without Bevacizumab
The objective of this phase 2 study is to examine the efficacy of erlotinib with or without bevacizumab in patients with stage IV non–small-cell lung cancer with epidermal growth factor receptor (EGFR) mutations. Patients aged ≥18 years with a life expectancy of ≥12 months, an Eastern Cooperative Oncology Group performance status 0 or 1, and a hemoglobin level of ≥9.0 g/dL may enroll if other criteria are met. Erlotinib is given orally once daily to both the comparator and experimental arms on days 1 through 21, and patients in the experimental arm receive a dose of intravenous bevacizumab for 30 to 90 minutes on day 1. Courses are repeated every 21 days for both arms until disease progression or unacceptable toxicity becomes evident. Patients are followed periodically for up to 5 years after study completion.

The primary outcome is progression-free survival of patients with EGFR mutations being treated with erlotinib in combination with bevacizumab versus erlotinib alone. Secondary outcomes include overall rate of survival, complete or partial response rate to each treatment method, adverse events, and progression-free survival of patients with other mutation types. This study expects to enroll 118 patients in multiple locations across the United States. For more information, contact Thomas Stinchcombe, MD, at 919-966-4431 orthomas_stinchcombe@med.unc.edu. The NLM Identifier is NCT01532089.


Denosumab with Chemotherapy as First-Line Treatment
This phase 2, randomized, double-blind study aims to study the effect of combining denosumab with standard chemotherapy in the treatment of patients with advanced lung cancer. Patients aged ≥18 years with stage IV, untreated non–small-cell lung cancer with or without bone metastasis may enroll if other inclusion criteria are met. Randomization occurs in a 2-to-1 ratio of patients receiving denosumab 120 mg to matching placebo subcutaneously every 3 or 4 weeks plus a loading dose on day 8 of the study. The first investigational product dose coincides with the patient’s first cycle of chemotherapy. Treatment continues until the time of the primary analysis, the patient is lost to follow-up, or the patient dies. All patients will receive daily dietary supplements of ≥500 mg of calcium and ≥400 IU of vitamin D.

The primary outcome is the relative benefit on overall survival of receiving denosumab in combination with standard of care (SOC) versus SOC alone. The secondary outcomes aim to correlate tumor tissue RANK and RANKL expression with the objective response rate and/or overall survival. Serum denosumab trough levels, and safety and tolerability of denosumab are measured. The study expects to enroll 216 patients and will take place in multiple locations across the United States, including California, New York, and Tennessee. For more information, contact the Amgen Call Center at 866-572-6436. The NLM Identifier is NCT01951586.


Safety and Efficacy of Adding Talactoferrin to Standard Chemotherapy
This is a phase 3, double-blind, safety and efficacy study comparing the combination of talactoferrin, carboplatin, and paclitaxel with the combination of paclitaxel and carboplatin in improving progression-free survival and overall survival in patients with non–small-cell lung cancer. Patients aged ≥18 years with at least 1 target lesion measurable by Response Evaluation Criteria in Solid Tumors are eligible if other criteria are met. In addition to carboplatin and paclitaxel, patients will receive 1.5 grams of twice-­daily placebo or talactoferrin.

The primary outcomes are overall and progression-free survival, and the secondary outcome measures include safety and tolerability, as well as objective response and disease stabilization rates. The study plans to enroll 1100 patients. For more information, contact Yenyun Wang, MD, at 713-552-1091 or ywang@agennix.com, or Rajesh Malik, MD, at 713-552-1091 or rmalik@agennix.com. The NLM Identifier is NCT00706862.


Bavituximab plus Docetaxel versus Docetaxel plus Placebo 
The purpose of this phase 3, double-blind study is to assess whether adding bavituximab to docetaxel will improve the results of treatment for patients with non–small-cell lung cancer (NSCLC). Patients must be aged ≥18 years, have histologic evidence of stage IIIB or IV nonsquamous NSCLC, have radiographic disease progression or recurrence during or after first-line, platinum-based doublet chemotherapy, and meet other criteria to enroll. Patients will receive docetaxel for 6, 21-day cycles with either bavituximab or a placebo on a weekly basis in the absence of disease progression.

The primary outcome is overall survival. Secondary outcomes include progression-free survival, overall response rate, and safety as measured by adverse event rates and laboratory procedures. The outcomes have a time frame of approximately 36 months. The study is expected to enroll 582 patients and be conducted at multiple locations across the United States, including Arizona, Oregon, and Wisconsin. For further information, contact Jennifer Lai, MBA, at 855-291-7867 or lungcancertrial@peregrineinc.com. The NLM Identifier is NCT01999673.


Carfilzomib with Irinotecan for Irinotecan-Sensitive Malignancies 
This is a phase 1b/2 trial. Phase 1b is an open-label study determining the maximum tolerated dose of carfilz­omib in combination with irinotecan in patients with relapsed small-cell lung cancer (SCLC) and non–small-cell lung cancer (NSCLC) or other irinotecan-sensitive cancers. Phase 2 assesses the 6-month survival of patients with relapsed SCLC treated with carfilzomib in combination with irinotecan. Secondary outcomes include response rate, progression-free survival, safety and tolerability, and rates of specified adverse events for a time frame of up to 6 months.

Phase 1b includes patients with advanced SCLC or NSCLC, or other cancers where irinotecan therapy has shown efficacy and for whom no curative therapy exists. Phase 2 includes patients with advanced-stage SCLC with progression or recurrence following 1 platinum-containing regimen. The trial plans to enroll 112 patients. For more information, contact Susanne M. Arnold, MD, at 859-323-8043 or smarno0@uky.edu, or Grace Powell, BA, at 206-839-1790 or gracep@crab.org. The NLM Identifier is NCT01941316.


Erlotinib Hydrochloride for Surgery-Removed Stage IB-II-IIIA NSCLC
The objective of this phase 3, randomized study is to determine the efficacy of erlotinib hydrochloride in treating patients with stage IB, II, and IIIA non–small-cell lung cancer (NSCLC) that has been completely removed by surgery. Patients aged ≥18 years with completely resected stage IB to IIIA NSCLC with negative margins who meet additional inclusion criteria may enroll in the study. Patients are randomized to either erlotinib hydrochloride or placebo. Treatment is given once a day orally on days 1 through 21, and repeated every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

The primary outcome is overall survival from time of randomization until time of death, with up to 5 years of assessment. Secondary outcomes include disease-free survival at a 2-year follow-up, overall survival rate defined as the proportion of patients alive 5 years after the date of randomization, and incidence of adverse events associated with each study group. The study expects to enroll 450 patients in multiple locations across the United States, including Iowa, Maryland, and Nevada. For more information, contact Ramaswamy Govindan, MD, at 314-362-5737 or rgovinda@dom.wustl.edu. The NLM Identifier is NCT02193282.


Nintedanib for Advanced NSCLC
This phase 2 trial studies the efficacy of nintedanib in treating patients with advanced non–small-cell lung cancer who have failed up to 2 previous chemotherapy regimens. Patients aged ≥18 years with an Eastern Cooperative Oncology Group performance status of ≤1 may enroll if other inclusion criteria are met. All patients will receive nintedanib orally twice a day on days 1 through 28. Courses are repeated every 28 days in the absence of disease progression or unacceptable toxicity.

The primary outcome is progression-free survival (PFS) rate of the fibroblast growth factor receptor 1 (FGFR1)-amplified patient group over a time frame of 6 months. The secondary outcomes include PFS rate for the FGFR1-amplified patient group compared with patients with wild-type FGFR1, PFS within each FGFR1-amplified group (low, intermediate, and high), overall survival, adverse events, and tumor response defined as partial or complete according to the Response Evaluation Criteria in Solid Tumors. This study expects to enroll 67 patients and will be conducted in New York at the Roswell Park Cancer Institute in Buffalo. For more information, contact Alex A. Adjei, MD, PhD, FACP, at 877-275-7724 or ASKRPCI@roswell park.org. The NLM Identifier is NCT01948141.


Crizotinib for Stage IB-IIIA NSCLC Removed by Surgery
This is a phase 3 study that evaluates whether crizotinib therapy adjuvant to surgical resection will result in improved overall survival (OS) compared with a placebo for patients with stage IB, II, and IIIA non–small-cell lung cancer with an anaplastic lymphoma kinase mutation. Patients aged ≥18 years without evidence of disease for 90 days in advance of randomization may enroll if other criteria are met. The experimental arm will receive crizotinib orally twice a day for days 1 through 21. Treatment is repeated every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. The placebo will be given in the same regimen.

Primary outcomes measure OS from time of randomization to time of disease recurrence, new lung cancer appearance, or death, assessed for up to 10 years. Secondary outcomes are assessed for up to 10 years and include disease-free survival and toxicity rates measured according to the Common Terminology Criteria for Adverse Events. This study plans to enroll 378 patients and will be conducted in Philadelphia, PA. For more information, contact David E. Gerber, MD, at 214-648-7097 or david.gerber@utsouth western.edu. The NLM Identifier is NCT02201992.


TH-302 or Placebo with Pemetrexed for Nonsquamous NSCLC
This is a phase 2, randomized, double-blind study determining whether TH-302 in combination with pemetrexed is safe and effective as second-line treatment for nonsquamous non–small-cell lung cancer (NSCLC). Patients aged ≥18 years with stage IIIB or IV NSCLC with nonsquamous histology and other criteria are eligible for enrollment. Patients are randomized to either TH-302 400 mg/m2 or a matching placebo, intravenously infused for 30 to 60 minutes on day 1 and day 8 of a 21-day cycle, and pemetrexed 500 mg/m2 intravenously infused on the first day, 2 to 4 hours after administration of TH-302 or placebo.

The primary outcome is the efficacy of pemetrexed in combination with TH-302 as determined by overall survival over a time frame of 2 years in patients in the second-line chemotherapy setting with advanced, nonsquamous NSCLC compared with pemetrexed in combination with placebo. Secondary outcomes include the incidence and severity of adverse events, pharmacokinetics of TH-302 in study patients, and antitumor activity between the 2 groups as measured by progression-free survival and response rates.

This study expects to enroll 440 patients at multiple locations across the United States, including Colorado, California, and Kentucky. For more information, contact Kristin Williams at 860-949-5311 or kristin.williams@psi-cro.com, or Mandeep Grewal at 650-474-8361 or mgrewal@thresholdpharm.com. The NLM Identifier is NCT02093962.


Custirsen for Patients with Stage IV NSCLC
This is a phase 3 study that compares the overall survival of patients receiving custirsen and docetaxel (Arm A) versus docetaxel alone (Arm B). Patients aged ≥18 years with stage IV non–small-cell lung cancer (NSCLC), a life expectancy >12 weeks from screening, and who received 1 previous line of platinum-based systemic anticancer therapy for advanced or metastatic NSCLC may enroll if other criteria are met. Both treatment arms will receive docetaxel 75 mg/m2 intravenously (IV) for 1 hour on the first day of every 21-day cycle. The experimental arm (Arm A) will also receive 3 loading doses of custirsen 640 mg IV for 2 hours administered 5 to 9 days prior to the first day of cycle 1, followed by custirsen 640 mg IV weekly every 21-day cycle. Treatment will continue until there is unacceptable toxicity, disease progression, withdrawal of consent, or protocol-specified parameters to curb treatment.
The primary outcome is overall survival, defined as the time between date of randomization and date of death from any cause. Secondary outcomes include progression-free survival, rate and duration of objective response, duration and rate of disease control, and adverse events. Data are collected over 60 months. The study plans to enroll 1100 patients, and study locations include Florida, North Carolina, and Texas. For more information, contact Teva US Medical Information at 800-896-5855. The NLM Identifier is NCT01630733.

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