Select Clinical Trials Currently Enrolling Patients with Lung Cancer

December 2015, Vol 5, No 9 - Clinical Trials Tracker


The following trials represent a selection of key clinical trials that are currently recruiting patients for inclusion in investigations of new therapies or new combinations of available therapies for patients with lung cancer. Each clinical trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. The information below can help oncology practice managers and providers direct their eligible patients to one of these clinical trials.

1 Bavituximab plus Docetaxel versus Docetaxel Alone in Patients with Late-Stage Nonsquamous Lung Cancer

This phase 3, randomized, double-blind, placebo-controlled, multicenter clinical trial examines whether adding bavituximab to the standard chemotherapy drug docetaxel will improve the results of treatment for patients with non–small-cell lung cancer (NSCLC). Patients aged ?18 years with histologically or cytologically confirmed and documented stage IIIb/IV nonsquamous NSCLC; radiographic disease recurrence or progression during or after frontline platinum-based doublet chemotherapy; an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; and adequate hematologic, renal, and hepatic function may be eligible for enrollment. Eligible patients will be randomized to six 21-day cycles of docetaxel plus weekly bavituximab or to docetaxel plus weekly placebo. Patients who have not experienced disease progression will continue to receive bavituximab or placebo weekly until progression.

The primary outcome measure is overall survival up to 36 months. The secondary outcome measures include progression-free survival, overall response rate, and safety. This study plans to enroll 582 patients at multiple locations across the United States and abroad.

For more information, contact Jennifer Lai, MBA, at 855-291-7867. The NLM Identifier is NCT01999673.

2 Ipilimumab plus Paclitaxel and Carboplatin versus Placebo plus Paclitaxel and Carboplatin in Patients with Squamous Lung Cancer

This phase 3, randomized, multicenter, double-blind, multinational clinical trial examines whether the use of ipilimumab plus paclitaxel and carboplatin will extend the life of patients with stage IV or recurrent squamous NSCLC more than placebo plus paclitaxel and carboplatin. Patients aged ?18 years with histologically confirmed squamous NSCLC, stage IV or recurrent NSCLC, ?1 measurable tumor lesions, and an ECOG performance status score of ?1 may be eligible for enrollment. Eligible patients will be randomized to receive carboplatin plus paclitaxel and ipilimumab or carboplatin plus paclitaxel and placebo.

The primary outcome measure is overall survival of up to 45 months in the population of all randomized patients who received ?1 doses of the blinded study therapy. The secondary outcome measures include progression-free survival of up to 45 months among patients who received blinded study therapy and overall survival of up to 45 months among all randomized patients. This study expects to enroll 867 patients at multiple locations in the United States and abroad.

For more information, e-mail Clinical.Trials@bms.com. The NLM Identifier is NCT02279732.

3 Alectinib with Crizotinib in Patients with Treatment-Naïve ALK-Positive Advanced NSCLC

The purpose of this phase 3, randomized, multicenter, open-label study is to evaluate the efficacy and safety of alectinib compared with crizotinib in patients with treatment-naïve anaplastic lymphoma kinase (ALK)-positive advanced NSCLC. Patients aged ?18 years with a histologically or cytologically confirmed diagnosis of advanced, recurrent, or metastatic NSCLC with ALK rearrangement, a life expectancy of ?12 weeks, and an ECOG performance status score of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive alectinib or crizotinib.

The primary outcome measure is progression-free survival of up to 33 months as assessed by investigators. Some of the secondary outcome measures include overall survival, quality of life, percentage of patients with adverse events, time to central nervous system progression, and duration of response. This study expects to enroll 286 patients at multiple locations across the United States and abroad.

For more information, contact Hoffmann-La Roche at 888-662-6728. The NLM Identifier is NCT02075840.

4 First-Line Therapy with MEDI4736 with/without Tremelimumab versus Standard of Care in NSCLC

This phase 3, randomized, open-label, multicenter, global study is comparing the efficacy and safety of MEDI4736 plus tremelimumab combination therapy and MEDI4736 monotherapy versus platinum-based standard-of-care chemotherapy in the first-line treatment of patients with EGFR and ALK wild-type advanced or metastatic NSCLC. Patients aged ?18 years with stage IV NSCLC, no activating EGFR mutation or ALK rearrangement, no previous chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC, and a World Health Organization performance status of 0 or 1 may be eligible for enrollment. Eligible patients will be randomized to receive MEDI4736 plus treme­limumab combination therapy, MEDI4736 monotherapy, or standard-of-care therapy.

The primary outcome measure is progression-free survival of up to 3 years. Some of the secondary outcome measures include disease-related symptoms and health-related quality of life. This study plans to enroll 675 patients at multiple locations across the United States and abroad.

For more information, contact the AstraZeneca Clinical Study Information Center at 877-240-9479. The NLM Identifier is NCT02453282.

5 Comparing Veliparib plus Carboplatin and Paclitaxel versus Standard Chemotherapy in Patients with Metastatic or Advanced Nonsquamous NSCLC Who Are Current/Former Smokers

This phase 3, randomized, open-label, multicenter clinical trial compares the safety and efficacy of veliparib plus carboplatin and paclitaxel versus the investigator’s choice of standard chemotherapy in current or former smokers who are receiving their first cytotoxic therapy for metastatic or advanced nonsquamous NSCLC. Patients aged ?18 years with cytologically or histologically confirmed advanced or metastatic nonsquamous NSCLC, current or former smokers, and patients with NSCLC that is not amenable to surgical resection or radiation with curative intent at the time of screening may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive veliparib plus carboplatin and paclitaxel or the investigator’s choice of platinum doublet chemotherapy.

The primary outcome measure is overall survival in current smokers. The secondary outcome measures include overall survival in all participants, progression-free survival in current smokers and all participants, and objective response rate in current smokers and all participants. This study plans to enroll 525 patients at multiple locations across the United States and abroad.

For more information, contact Angela M. DeLuca at 847-936-3354 or Jade M. Irving at 847-935-2145. The NLM Identifier is NCT02264990.

6 Ganetespib in Combination with Docetaxel versus Docetaxel Alone in Patients with Advanced NSCLC

This randomized, phase 3 study is evaluating whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in patients with advanced NSCLC. Patients aged ?18 years with advanced stage IIIB or IV NSCLC, an ECOG performance status score of 0 or 1, and 1 previous systemic therapy for advanced disease may be eligible for enrollment if other criteria are met. Eligible patients will receive ganetespib in combination with docetaxel or docetaxel alone.

The primary outcome measure is overall survival. Some of the secondary outcome measures include progression-free survival, objective response rate, and duration of response. This study expects to enroll 850 patients at multiple locations in the United States and abroad.

For more information, contact the Synta Pharmaceuticals ClinicalTrials.gov Call Center at 855-499-9664. The NLM Identifier is NCT01798485.

7 Radiation Therapy in Patients with NSCLC That Has Been Removed by Surgery

This randomized, open-label, parallel-assignment, phase 3 study is comparing radiation therapy with no radiation therapy in patients with NSCLC that has been completely removed by surgery. Patients aged ?18 years with histologically confirmed NSCLC, mediastinal lymph node exploration, and a World Health Organization performance score of ?2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive radiation therapy or no radiation therapy.

The primary outcome measure is disease-free survival. The secondary outcome measures include acute and late toxicity, local control, patterns of failure, overall survival, second cancers, prognostic and predictive factors of treatment effect on disease-free survival and overall survival, and cost per recurrence-free year of life. This study plans to enroll 700 patients in France.

For more information, contact Cécile Le Pechouxat at cecile.lepechoux@igr.fr or Ariane Dunant at ariane.dunant@igr.fr. The NLM Identifier is NCT00410683.

8 AZD9291 versus Gefitinib or Erlotinib in Patients with Locally Advanced or Metastatic NSCLC

The purpose of this phase 3, double-blind, randomized study is to assess the efficacy and safety of AZD9291 versus a standard-of-care EGFR tyrosine kinase inhibitor in patients with locally advanced or metastatic NSCLC. Patients aged ?18 years with pathologically confirmed adenocarcinoma of the lung, with locally advanced or metastatic NSCLC, and who are eligible to receive first-line treatment with gefitinib or erlotinib as selected by the participating center may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to AZD9291 plus placebo and erlotinib or placebo and gefitinib.

The primary outcome measure is progression-free survival, which is defined as the time from randomization until the date of objective disease progression or death. Some of the secondary outcome measures include overall survival, objective response rate, and depth of response. This study expects to enroll 530 patients at multiple locations across the United States and abroad.

For more information, contact Ewa Nowak at 877-240-9479. The NLM Identifier is NCT02296125.

9 Immunotherapy with Racotumomab in Patients with Advanced Lung Cancer

The purpose of this prospective, randomized, open-label, parallel-group, multicenter phase 3 study is to evaluate the efficacy and safety of active specific immunotherapy with racotumomab plus best supportive care versus best supportive care in patients with advanced NSCLC who have achieved an objective response or stable disease with standard first-line treatment. Patients aged ?18 years with cytologically or histologically diagnosed stage IIIA, IIIB, or IV NSCLC, in continuous complete or partial remission or stable disease, and who have an ECOG performance status score of <2 may be eligible for enrollment if other criteria are met. Eligible patients will receive racotumomab plus best supportive treatment or best supportive treatment alone.

The primary outcome measure is overall survival. Some of the secondary outcome measures include the number of patients with adverse events and progression-free survival. This study plans to enroll 1082 patients at multiple locations abroad, including Argentina, Brazil, Cuba, Indonesia, the Philippines, Singapore, and Thailand.

For more information, contact Belen Liebana, PharmD, at belen.liebana@chemogroup.net or Roberto Gómez, MD, at gomezr@recombio.com. The NLM Identifier is NCT01460472.

10 Bevacizumab or Pemetrexed Disodium Alone or in Combination After Induction Therapy for Patients with Advanced Nonsquamous NSCLC

This randomized, phase 3, open-label clinical trial is evaluating the efficacy of bevacizumab and pemetrexed disodium alone or in combination after induction therapy in patients with advanced nonsquamous NSCLC. Patients aged ?18 years with cytologically or histologically confirmed NSCLC, an ECOG performance status score of 0 to 1, and ?12 months since their previous adjuvant chemotherapy may be eligible for enrollment if other criteria are met. Eligible patients will receive bevacizumab, pemetrexed, or a combination of bevacizumab and pemetrexed after receiving therapy with carboplatin, paclitaxel, and bevacizumab.

The primary outcome measure is overall survival. Some of the secondary outcome measures include progression-free survival, objective response, and toxicity. This study plans to enroll 1282 patients across the United States.

For more information, contact Suresh Ramalingam, MD, at 404-778-1900. The NLM Identifier is NCT01107626.

11 Patritumab in Combination with Erlotinib in Patients with Locally Advanced or Metastatic NSCLC

This phase 3, randomized, placebo-controlled, double-blind, multicenter study is evaluating the efficacy of patritumab (U3-1287) in combination with erlotinib in patients with EGFR wild-type locally advanced or metastatic NSCLC that has progressed after ?1 previous systemic therapies. Patients aged ?20 years with cytologically or histologically confirmed NSCLC with metastatic disease or stage IIIB disease not amenable to surgery or curative intent, and an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive patritumab with erlotinib or placebo with erlotinib.

The primary outcome measure is overall survival as assessed every 12 weeks. The secondary outcome measure is progression-free survival. This study expects to enroll 724 patients at multiple locations across the United States and abroad.

For more information, contact PARAXEL International at 919-544-2640. The NLM Identifier is NCT02134015.

12 Afatinib Dimaleate with or without Cetuximab in Patients with Newly Diagnosed Stage IV or Recurrent EGFR Mutation–Positive NSCLC

The purpose of this phase 2/3 randomized, open-label, parallel-assignment study is to evaluate the efficacy of afatinib dimaleate in combination with cetuximab compared with afatinib dimaleate alone for the treatment of patients with newly diagnosed stage IV or recurrent NSCLC associated with EGFR mutation. Patients with histologically or cytologically confirmed stage IV or recurrent NSCLC and a Zubrod performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients are randomized to receive afatinib dimaleate with cetuximab or afatinib dimaleate alone.

The primary outcome measures are overall survival and progression-free survival. The secondary outcome measures include response rate, toxicity, and time to treatment failure. This study plans to enroll 605 patients at multiple locations across the United States.

For more information, contact Gretchen Goetz at 210-614-8808, ext 1002 or Dana Sparks at 210-614-8808, ext 1004. The NLM Identifier is NCT02438722.

13 Onartuzumab Combined with Erlotinib in Patients with MET-Positive NSCLC

The purpose of this randomized, phase 3, double-blind, placebo-controlled study is to evaluate the safety and efficacy of onartuzumab in combination with erlotinib compared with erlotinib alone in patients with incurable MET-positive NSCLC. Patients aged ?18 years with histologically confirmed incurable stage IIIB/IV NSCLC and an ECOG performance status score of 0 to 1 may be eligible for enrollment if other criteria are met. Eligible patients are randomized to receive onartuzumab with erlotinib or erlotinib alone.

The primary outcome measures are overall survival and the incidence of adverse events. The secondary outcome measures include progression-free survival, overall response rate, health-related quality of life, and the incidence of anti­therapeutic antibodies against MetMAb. This study plans to enroll 530 patients at multiple locations abroad.

For more information, contact Hoffmann-La Roche at 888-662-6728. The NLM Identifier is NCT02031744.

14 Nivolumab with and without Ipilimumab versus Platinum Doublet Chemotherapy in Patients with Stage IV NSCLC

The purpose of this randomized, phase 3, double-blind, placebo-controlled study is to determine whether nivolumab or nivolumab plus ipilimumab improves progression-free survival and/or overall survival compared with chemotherapy in patients with advanced NSCLC. Patients aged ?18 years with histologically confirmed stage IV or recurrent NSCLC with squamous or nonsquamous histology and with no previous systemic anticancer therapy may be eligible for enrollment if other criteria are met. Eligible patients are randomized to receive nivolumab, nivolumab plus ipilimumab, or platinum doublet chemotherapy.

The primary outcome measures are overall survival and progression-free survival. The secondary outcome measures include objective response rate and disease-related symptom improvement. This study plans to enroll 1980 patients at multiple locations in the United States and abroad.

For more information, contact Clinical.Trials@bms.com. The NLM Identifier is NCT02477826.

15 Cisplatin in Combination with Gemcitabine for Elderly Patients with Lung Cancer

The purpose of this randomized, double-blind, open-label, parallel-assignment phase 3 study is to evaluate the addition of cisplatin to first-line chemotherapy with gemcitabine in elderly patients with NSCLC. Patients aged ?70 years with ?1 target or nontarget lesions and an ECOG performance status score of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients are randomized to receive cisplatin plus gemcitabine or gemcitabine alone.

The primary outcome measure is overall survival. The secondary outcome measures include worst grade toxicity per patient, progression-free survival, quality of life, and objective response. This study plans to enroll 480 patients at multiple locations in Italy.

For more information, contact Francesco Perrone, MD, PhD, at francesco.perrone@usc-intnapoli.net or Maria Carmela Piccirillo, MD, at marilina.piccirillo@usc-intnapoli.net. The NLM Identifier is NCT01405586.