Breast:

“A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women With Early-Stage Breast Cancer at High Risk of Recurrence”

For:  Early-Stage (II or III) Breast cancer at high risk of recurrence
Why: Bone is a frequent site of relapse in women with early-stage breast cancer. Also, most women with advanced breast cancer will develop disease in the bone. Denosumab may be able to interrupt the process that causes cancer cells to enter the bone (or the rest of the body), thus preventing bone destruction due to cancer.
What: Patients receive treatment chosen by doctor (chemotherapy and/or endocrine therapy and/or HER-2 targeted therapy). Patients additionally receive an injection of denosumab or placebo every 3 or 4 weeks.

“A multicenter, open-label, randomized trial to evaluate the anti-cancer effects of zoledronic acid using circulating tumor cell measurements in patients with newly diagnosed HER2-negative metastatic breast cancer”

For: Women with HER2-negative metastatic breast cancer (stage IV).
Why: There is some association between circulating tumor cells and poor prognosis/outcomes in patients with metastatic disease. Circulating tumor cells (CTCs) may help predict which treatments will be most effective against metastatic disease. Zoledronic acid may be effective in early-stage breast cancer, but effect in metastatic disease is not known yet. This study will look at how effective zoledronic acid is in metastatic patients using CTCs as a biomarker.
What: Patients are randomized to one of three arms. Those without bone metastasis will receive either standard therapy and upfront zoledronic acid (monthly during months 1-6) or delayed zoledronic acid (monthly during months 7-12). Those with bone metastasis will receive standard therapy and upfront zoledronic acid (monthly during months 1-18). 

Colorectal:

“A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Pegfilgrastim Administered to Subjects With Newly Diagnosed, Locally-advanced or Metastatic Colorectal Cancer Treated With Bevacizumab & Either 5- Fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI)”

For: Patients with newly-diagnosed, locally-advanced, or metastatic colorectal cancer. Must not have had treatment previously for cancer, and must be getting bevacizumab with either FOLFOX or FOLFIRI chemotherapy regimens.
Why: This study adds pegfilgrastim (Neulasta) or placebo to bevacizumab and chemotherapy to try to reduce the occurrence of febrile neutropenia, or fever in patients with low white blood cell counts. By raising white blood cells, pegfilgrastim helps patients undergoing chemotherapy to fight infection.
What: Patients receive bevaciuzumab and chemotherapy (FOLFOX or FOLFIRI, chosen by their doctor) every two weeks for two months, totaling 4 cycles. Patients also receive an injection of either Pegfilgrastim (6 mg) or placebo 24-hours after chemotherapy.

Lung:

“A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (> 4cm)-IIIA Non-Small Lung Cancer (NSCLC)”

For: Patients with Stage IB, Stage II, or Stage IIIA non-small cell lung cancer that was removed by surgery
Why: Combination chemotherapy (more than one drug) may help kill more tumor cells because different drugs work differently to kill those cells. Adding Bevacizumab to chemotherapy may help kill any tumor cells left over after surgery.
What: Patients receive standard of care chemotherapy with or without bevacizumab. The doctor chooses which of the four chemotherapy regimens the patient will have (cisplatin/vinorelbine ditartrate vs cisplatin/docetaxel vs cisplatin/gemcitabine hydrochloride vs cisplatin/pemetrexed disodium). Treatment is given every 21days for up to 4 cycles.

 “A Randomized, Multicenter, Open-Label Phase IV Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Gemcitabine-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)  (SQUIRE)”

Who: Patients with Stage IV Squamous Non-Small Cell Lung Cancer, First line therapy
Why: Necitumumab is an antibody that binds to epidermal growth factor receptors. A previous study adding cetuximab (an antibody that binds to the same epidermal growth factor receptors) to chemotheraoy in patients with Stage IV Nonsquamous NSCLC showed improved survival versus chemotherapy alone. This study hopes to determine if adding Necitumumab to chemotherapy (cisplatin/gemcitabine) will improve survival also.
What: Patients receive either standard of care chemotherapy (cisplatin/gemcitabine) and the investigational product (Necitumumab) or chemotherapy alone. Cisplatin is given Day 1 of every 3-week cycle, for up to 6-cycles. Gemcitaibe is given Day 1 and Day 8. For patients receiving the investigational product, Necitumumab is given Day 1 and Day 8 of each cycle.

“A Randomized Double-blind Multicenter Phase III Trial of BIBF 1120 Plus Pemetrexed vs. Pemetrexed/ Placebo in Advanced or Recurrent Non Small Cell Lung Cancer (NSCLC) Patients After Failure of First Line Therapy”

Who: Patients with stage IIIB, IV or recurrent Non Small Cell Lung Cancer who had progression of disease under their first chemotherapy. 2nd Line therapy
Why: Most patients with locally advanced or metastatic NSCLC relapse after failure of first-line therapy. BIBF 1120 inhibits the growth of new blood vessels, so this study is to see if BIBF 1120 will help to slow tumor growth in humans.
What: Pemetrexed is given intravenously Day 1 of every 21-day cycle. BIBF 1120 is taken orally twice daily Days 2 to 21.

“A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 µg Once-Every-3-Weeks in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer (NSCLC) Receiving Multi-cycle Chemotherapy”

Who: Patients with Stage IV NSCLC (not recurrent or re-staged) who will receive at least 2 more cycles of chemotherapy
Why: Chemotherapy often causes patients to become anemic, or to lose red blood cells, which carry oxygen. Darbeopetin Alfa is an erythropooiesis-stimulating agent, which means it causes the body to produce more red blood cells. It is already proven to be effective in treating anemia for other conditions (chronic kidney failure and cancer that did not start in the bone marrow).
What: Along with chemotherapy, patients receive Darbepoetin alfa or placebo on Day 1 of every cycle, a cycle being 3 weeks long. Patients continue on the study until worsening of disease (progression).

“A Multi-center Phase III Randomized, Double-blind Placebo-controlled Study of the Cancer Vaccine Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Non-small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease.”

Who: Patients with Non-Small Cell Lung Cancer, stage III unresectable disease.
Why: The purpose of this study is to determine whether the cancer vaccine Stimuvax in addition to best supportive care is effective in prolonging the lives of patients with unresectable stage III non-small cell lung cancer, compared to best supportive care alone.
What: To be eligible subjects will have demonstrated either stable disease or objective response after primary chemo-radiotherapy. Excludes brain metastasis.