Lung Cancer

Clinical Trials

2012-186

Title: A Pilot Prospective Study Correlating CYP19A1 Polymorphisms with Estrogen Alpha/Beta Receptor Expression and Hormonal Levels in Postmenopausal African American Females Compare to White Females with Newly Diagnosed Non-Small Cell Lung Cancer (NSCLC) Tumors.

Description: Recent research shows that many lung cancers are influenced by hormones. Targeting hormonal receptors has revolutionized the way that certain cancers are treated. Research is currently underway to determine whether lung cancer can also be controlled implementing hormonal methods.

Currently there is no conclusive evidence if having higher estrogen or other hormonal levels in the blood predispose y to hormonal sensitive lung cancers. This study will attempt to see whether lung cancer is hormonally sensitive.

Also, there has been recent research showing that genetic variations in Japanese females, may predispose them towards certain types of lung cancer. Currently it is not known whether African American or Caucasian females are similarly predisposed to lung cancer because of these genetic variation called single nucleotide polymorphisms (SNPs). This study will attempt to clarify whether this is the case.

2013-0036

Title: A Phase II/III Randomized Trial of Two Doses of MK-3475 (SCH900475) versus Docetaxel in Previously Treated Subjects with Squamous Histology Non-Small Cell Lung Cancer

Description: This is a randomized phase II/III study to test the safety and tolerability of the research study drug, MK-3475 compared to the standard of care, docetaxel for squamous non-small cell lung cancer, measured by the rates of response to treatment and survival. Both Mk-3475 and docetaxel will be given intravenously (through a needle in a vein) once every three weeks. Treatment will be assigned by chance (randomized) to one of the following groups: MK-3475 at a dose of 2mg/kg or 10mg/kg OR Docetaxel at a dose of 75 mg per area of your body according to a specific formula. Patients will be seen in clinic for treatments, routine care, and safety evaluations. Patients will also be seen for a 30 day follow up after their last dose of medication.

For information on this study from ClinicalTrials.gov, click here!

2013-1373

Title: CO-1686-008 - A Phase 1/2, Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of Oral CO-1686 in Patients with Previously Treated Mutant EGFR Non-Small Cell Lung Cancer (NSCLC)

Description: The drug being investigated in this study is called CO-1686. CO-1686 is not approved by the US Food and Drug Administration (FDA) and is being studied in people with lung cancer to find out if it is safe, and if it helps stop tumors from growing.

This study has two parts. The first part of the study was open to people whose lung cancer had mutations, and whose cancer came back after treatment with other cancer drugs . The main goal of Part 1 of the study was to help decide the best dose level of CO-1686 to begin the actual testing in Part 2.

Part 2 of the study is only open to people with lung cancer who have a mutation called T790M and whose cancer came back after treatment with other cancer drugs.

For information on this study from ClinicalTrials.gov, click here!

2013-0223 

Title: A7471047: Phase 2 Open-Label Trial of Oral Intermittent Dacomitinib in Patients with Advanced NSCLC.

Description: The purpose of this study is to evaluate the safety and efficacy of an intermittent regimen of dacomitinib in subjects with non-small cell lung cancer.

For information on this study from ClinicalTrials.gov, click here!

2013-1184

Title: 59R5-003: A Phase 1b/2 Study of OMP-59R5 in Combination with Etoposide and Cisplatin in Subjects with Untreated Extensive Stage Small Cell Lung Cancer

Description: Many current cancer therapies often produce an initial reduction in tumor size but may not have long-term benefits. One possible explanation for this is the presence of a specific type of cancer cell known as a cancer stem cell. Cancer stem cells make up a small part of the tumor but are believed to be responsible for much of the growth and spread of the cancer. Cancer stem cells may also be more resistant to traditional types of therapy, such as chemotherapy and radiation therapy.

The study drug, OMP-59R5, used in this study is experimental. This means that the United States Food and Drug Administration (FDA) has not approved it for use by the general public. OMP-59R5 is a humanized monoclonal antibody and was developed to target cancer stem cells. OMP-59R5 may block the growth of cancer stem cells, and/or the remaining tumor cells.

This study consists of two parts and you will participate in one of the two parts. The purpose of the first part is to test the safety and to determine the highest tolerable dose of OMP-59R5, when given in combination with etoposide and cisplatin. Etoposide and cisplatin are drugs that are a standard treatment for extensive small cell lung cancer. The purpose of the second part is to test if OMP-59R5, when given in combination with etoposide and cisplatin, is able to shrink or slow tumor growth or increase how long subjects with extensive small cell lung cancer live.

Although OMP-59R5 has been given to cancer patients, it has not been given in combination with etoposide and cisplatin. It is not known if it will provide any benefit to you and may cause harmful side effects.

For information on this study from ClinicalTrials.gov, click here!

2013-0916

Title: CDKO-125a-007: Phase II study of oral PHA-848125AC in patients with malignant thymoma previously treated with multiple lines of chemotherapy.

Description: You are being asked to participate in this study because you have thymus cancer that has previously been treated with chemotherapy. 

You are being asked if you want to take part in a research study using an experimental drug called PHA-848125AC. This means that PHA-848125AC has not been approved by the U.S. Food and Drug Administration (FDA). PHA-848125AC is a new drug that is being studies in humans because of its antitumor activity in research studies done in the laboratory. This drug acts by blocking specific proteins (called cyclin-dependent kinases) involved in how cells divide. In the case of tumor cells the normal control of how cells divide is altered and leads to abnormal cell growth. Experiments have shown that PHA-848125AC may block this uncontrolled cell growth. Treatment with PHA-848125AC may help stop your tumor from growing. All subjects will be all treated at the same dose of PHA-848125AC; this dose has been selected based on results of the first clinical study in solid tumors patients where patients treated at this dose had mild/moderate reversible adverse events, mainly nausea, vomiting, diarrhea and tremors. The dose of PHA-848125AC will never be increased and could be reduced based on the side effects you experience.

For information on this study from ClinicalTrials.gov, click here!

2013-1373

Title: A Phase 1/2, Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of Oral CO-1686 in Patients with Previously Treated Mutant EGFR Non-Small Cell Lung Cancer (NSCLC)

Description: 

Purpose part 1:
The purpose of this part is to determine:
• The highest dose of CO-1686 that can safely be given to patients
• The dose of CO-1686 that has the best overall profile. This includes side effects and measured amounts of CO-1686 in the blood at different times.
• What effects, good and/or bad, CO-1686 has on you and on your disease
• The effects of CO-1686 on your heart rate and rhythm
• The amount of CO-1686 you have in your blood at different times
• What type of EGFR mutations and other biomarkers are found in your blood and tumor tissue samples.
• Whether EGFR mutations can be found in samples of your urine (optional part of the study)
• If the symptoms you experience from your cancer change with treatment of CO-1686
• The study may also look at whether taking CO-1686 more or less frequently has an effect on the amount of CO-1686 in your blood at different times. (If this is tested, only a few people who take part in this study.)

The purpose of Part 2 is to determine:
• What effects, good and/or bad, CO-1686 has on you;
• How your cancer responds to treatment with CO-1686;
• The amount of CO-1686 in your blood;
• How CO-1686 is changed after it enters the body. This is called “metabolite profiling” and may only be tested in a few people who join Part 2 of this study. Your study doctor will tell you if you will be taking part in “metabolite profiling.”
• The type and amount of EGFR mutations in your blood and tumor cells;
• Changes in biomarkers that may be important in your type of lung cancer and help show who will or who will not respond to treatment with CO-1686;
• If the symptoms you experience from your cancer change with treatment of CO-1686.
• If EGFR mutations can be found in urine samples. This is an optional part of the study. 

For information on this study from ClinicalTrials.gov, click here!

2014-0594

Title: A single arm, open-label, phase II study to assess the efficacy of the dual VEGFR-FGFR tyrosine kinase inhibitor, lucitanib, given orally as a single agent to patients with FGFR1-driven lung cancer

Description: The purpose of this study is to evaluate the efficacy and safety of lucitinib in patients with FGFR1-amplified squamous non-small cell lung cancer (NSCLC).

For information on this study from ClinicalTrials.gov, click here!

2014-0242

Title: A Randomized Phase 3 Open Label Study of Nivolumab versus Bevacizumab and a Safety Study of Nivolumab or Nivolumab in Combination with Ipilimumab in Adult Subjects with Recurrent Glioblastoma (GBM)

Description: The purpose of this study is to establish the safety, tolerability and efficacy of nivolumab and nivolumab in combination with ipilimumab versus standard of care treatment (bevacizumab) in patients diagnosed with recurrent glioblastoma. 

For information on this study from ClinicalTrials.gov, click here!

2013-0342

Title:A Phase 1, Open-label, Dose-escalation Study of SNX-5422 plus Carboplatin and Paclitaxel in Subjects with Selected Solid Tumors

Description: To determine the maximum tolerated dose (MTD) of SNX-5422 when combined with carboplatin plus paclitaxel in selected solid tumors. To assess the efficacy of SNX-5422 as maintenance therapy in selected solid tumors and how well SNX-5422 is tolerated.

For information on this study from ClinicalTrials.gov, click here!

2014-0401

Title: An Open-label, Phase 1 Dose Escalation Study of Oral ASP8273 in Subjects with Non-Small-Cell Lung Cancer (NSCLC) who Have Epidermal Growth Factor Receptor (EGFR) Mutations

Description: The purpose of this study is to assess the safety of ASP8273 and to determine a safe dose of the study drug in patients with advanced Non-Small Cell Lung Cancer (NSCLC).

For information on this study from ClinicalTrials.gov, click here!

2014-0363

Title:  A Randomized, Double-blind, Placebo-controlled, Phase 2 Clinical Trial of Alisertib (MLN8237) in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel as Second Line Therapy for Small Cell Lung Cancer (SCLC)

Description: The purpose of this study is to evaluate the safety and efficacy of the combination of alisertib + paclitaxel compared with placebo + paclitaxel in patients with small cell lung cancer who have relapsed or did not respond to first line standard therapy 

For information on this study from ClinicalTrials.gov, click here!

2014-1240

Title: A081105: Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)

Description: The purpose of this study is to compare any good and bad effects patients may have when treated with the standard treatment against patients who are treated with the standard treatment plus erlotinib (an investigational drug). You are being asked to take part in this research study because you have early stage non-small cell lung cancer that was surgically removed and may have been treated with chemotherapy and/or radiation. The tumor removed has a mutation of a gene called EGFR (Epidermal Growth Factor Receptor). We are trying to find out if this mutation could help us make decisions about which type of treatment is best for people with your type of
cancer. People not in a research study are usually not treated with anything after they finish their chemotherapy although some of them may receive radiation therapy.

For information on this study from ClinicalTrials.gov, click here!

2014-1241

Title: A151216: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

Description: The purpose of this research study is to examine lung cancer patients’ surgically removed tumors for certain genetic changes, and to possibly refer these patients to a treatment study with drugs that may specifically target tumors that have these genetic changes.

For information on this study from ClinicalTrials.gov, click here!

2014-1242

Title: ECOG E4512: A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib Versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

Description: The purpose of this research study is to compare any good and bad effects of using the study drug, crizotinib (also known as XALKORI®), after completion of surgery and, in some cases, after chemotherapy and/or radiation therapy for ALK-positive non-small cell lung cancer. The addition of crizotinib may help prevent your cancer from returning, but it could also cause side effects. This research study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the study drug should improve how long you are able to live by 2 years and 9 months (33 months total) or more compared to the usual approach. The study drug, crizotinib, is already FDA-approved for use in ALK-positive locally advanced or metastatic (spread to other areas of the body) non-small lung cancer. The use of crizotinib in this study is investigational (not approved by the FDA) because crizotinib (or placebo) will be prescribed for earlier stage disease after the cancer has been surgically removed. A placebo is a capsule that looks like the study drug but contains no medication.  Patients taking low dose Methotrexate for non-malignant conditions and other cytotoxic agents for nonmalignant conditions are allowed to continue treatment while on study.

For information on this study from ClinicalTrials.gov, click here!

2014-0746

Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre, International Study of MEDI4736 as Sequential Therapy in Patients with Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Foll

Description: The purpose of this study is to see if MEDI4376 (referred to as the “study drug” from now on) is effective and safe in treating lung cancer.

For more information on this clinical trial from ClinicalTrials.gov, click here!

2014-1038

Title: TIGER-1: A Randomized, Open-Label, Phase II Study of CO-1686 or Erlotinib as First-Line Treatment of Patients with EGFR-Mutant Advanced Non-Small Cell Lung Cancer (NSCLC)

Description: To compare the antitumor efficacy of oral single-agent CO-1686 to erlotinib when administered as a first line targeted treatment to patients with EGFR-mutated, advanced NSCLC and to assess the safety and tolerability of CO-1686 in this population.

For information on this study from ClinicalTrials.gov, click here!

2013-1195

Title: A Phase I Study of Ganetespib in Combination with Doxorubicin in Solid Tumors

Description: The main purpose of this study is to determine the maximum dosages that patients can tolerate when these two medicines are given at the same time.

For information on this study from ClinicalTrials.gov, click here!

2014-0042

Title: Phase II Study of Cabozantinib in Patients with Radioiodine-Refractory Differentiated Thyroid Cancer Who Progressed on First-Line VEGFR-Targeted Therapy

Description: The purpose of this study is to evaluate the effect that cabozantinib, a new anti-cancer drug, has on cancer.

For information on this study from ClinicalTrials.gov, click here!

2014-0593

Title: A Phase I/II Trial Of Cetuximab In Combination With Interleukin-12 Administered To Patients With Unresectable Primary Or Recurrent Squamous Cell Carcinoma Of The Head And Neck

Description: The purpose of this study is to find out if interleukin-12 can be used in combination with cetuximab in patients with cancer of the Head and Neck.

For information on this study from ClinicalTrials.gov, click here!

2014-1022

Title: MK-3475-055: A Phase II Clinical Trial of Single Agent Pembrolizumab (MK-3475) in Subjects with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) who have Failed Platinum and Cetuximab

Description: The purpose of this study is to examine the safety and efficacy of pembrolizumab in subjects with recurrent and/or metastatic head and neck squamous cell carcinoma who have progressed on platinum and cetuximab therapy. 

For information on this study from ClinicalTrials.gov, click here!

2014-0553

Title: A Randomized Open-Label Phase III Trial of MK-3475 versus Platinum based Chemotherapy in 1L Subjects with PD-L1 Strong Metastatic Non-Small Cell Lung Cancer

Description:  The purpose of this study is to: 

• Test the safety and tolerability of the research study drug, MK-3475
• Test the effectiveness of the research study drug MK-3475 in subjects with PD-L1 strong metastatic non-small cell lung cancer measured by the rates of response to treatment, survival, and disease progression (disease getting worse).

For information on this study from ClinicalTrials.gov, click here!

2014-1315

Title:  A Phase II Study of MK-3475 in Patients with Thymic Carcinoma

Description: The purpose of this study is to determine the effects (good and bad) of MK-3475 in patients with cancer of the thymus.

For information on this study from ClinicalTrials.gov, click here!

2014-1189

Title: A Randomized, Double-Blind Phase 2 Study of Ruxolitinib or Placebo in Combination With Pemetrexed/Cisplatin and Pemetrexed Maintenance for Initial Treatment of Subjects With Nonsquamous Non–Small Cell Lung Cancer That Is Stage IIIB, Stage IV, or Recurrent

Description: There are two parts to this study; the main purpose of Part 1 of this study is to determine a dose of ruxolitinib that is safe and tolerable in combination with pemetrexed/cisplatin. The main purpose of Part 2 of this study is to find out if taking ruxolitinib in combination with pemetrexed/cisplatin is better than taking a placebo in combination with pemetrexed/cisplatin.

For information on this study from ClinicalTrials.gov, click here!

2014-1073

Title: A Randomized, Phase 2 Study of INCB039110 or Placebo in Combination With Docetaxel in Subjects With Previously Treated Stage IIIb, IV, or Recurrent Non–Small Cell Lung Cancer

Description: The purpose of the safety run-in phase is to evaluate the safety and tolerability of INCB039110 in combination with docetaxel and select their doses for further evaluation. The purpose of the randomized phase of the study is to evaluate and compare the efficacy of INCB039110 in combination with docetaxel compared to docetaxel alone in subjects with previously treated advanced or metastatic non-small cell lung cancer.

For information on this study from ClinicalTrials.gov, click here!