A clinical trial is a research study that involves volunteers to test new drugs, treatments and diagnostic tools to help doctors better understand how to diagnose, treat and prevent diseases or conditions.

Clinical trials are vital in studying all aspects of medicine with the goal of helping patients live longer, healthier lives. In the United States, the Food and Drug Administration (FDA) requires all new drugs and other treatments to be tested in clinical trials before being approved. Clinical trials show us what works in medicine and healthcare.

They are the best way to learn what works best in treating diseases like cancer. Patients who choose to participate in a trial at Alpha, receive most advanced cancer treatment available, sometimes years before it is offered to the public.

Studies

Oncology

Neurology

Nephrology

Types of Clinical Trials

Treatment Trials

Tests new drugs or new combination of drugs. These trials also test new approaches to surgery or giving radiation therapy.

Prevention Trials

Focus on the use of different medications or change in diet and exercise to determine if the risk of developing cancer decreases or stop it from recurring.

Diagnostic Trials

They find new ways to understand a particular disease or condition.

Screening Trials

Test the best way to detect cancer earlier.

Quality of Life Trials

Cancer can affect people’s health for years, so doctors explore ways to better manage and improve comfort for people who are living with cancer through supportive care trials. Doctors are always looking for ways to make people with cancer feel better.

Participate in a Clinical Trial

The best way to find a clinical trial is to first speak with your doctor and ask about trials that may be appropriate for your cancer type and stage. We have a Research Team here at Alpha, offering clinical trials that are available to our patients with cancer. If your doctor recommended a clinical trial that you are eligible to participate in and have additional questions, please feel free to contact our research staff for further assistance. They are always happy to explain details of a particular study including the trial’s purpose, how long it will take, what to expect, all potential risks and benefits and information on the privacy of your medical records.

Every clinical trial has its own protocol that determines the eligibility criteria needed in order to participate in that study. Following eligibility criteria helps the doctor and clinical trial research team keep you safe, makes sure the trial treatment is right for you and ensures that researchers learn the information they need. No treatment or procedure, even one already in common use, is entirely without risk. But ask yourself, do the benefits of the new treatment outweigh the possible risks?

It is important to share information about your health with the research team during and after the treatment. They are interested in all the details of your health during the clinical trial. Our highly experienced and compassionate physicians and staff focus on patient safety and care.

Phases of Clinical Trials

On average, a new cancer drug has been studied for at least 6 years before it even makes it to clinical trials. Phases are the stages a clinical trial must go through before they are released to the general public. Every new treatment is tested in 3 or more phases of clinical trials to determine drug dose, safety and effectiveness. The main phases are Phase I, Phase II and Phase III. The different phases give doctors different information about the treatment being studied.

A person does not go through each phase of a clinical trial. You can join a clinical trial at any phase. You can always leave a clinical trial at any time for any reason. If you decide to leave the study, talk to your doctor first to go over the affects it may have on your health and what other treatment options are available for you.

Phase I

The most critical phase due to the development of a new drug or treatment. The main goal is to determine how well it works against a particular type of cancer, along with safety, best uses, dosage, frequency of dosage and identify side effects.

Phase II

Trials study the safety and effectiveness of the treatment and evaluate how it affects the human body. This phase usually focuses on a similar type of cancer amongst patients.

Phase III

Includes physicians and other investigators to conclude the effectiveness of the new drugs or treatment by comparing new drugs or treatment with the current available treatments. Researchers are trying to see which approach is safer and more effective. In most cases, studies move into Phase III testing only after they have shown promise in Phase I and Phase II. After a treatment passes Phase III, it is submitted for approval by the FDA and once approved; it is made available for the general public.

Phase IV

After the FDA approves a treatment, it may be studied further to examine the safety and effectiveness of a treatment over a long period of time and among a wider patient population. Phase IV trials evaluate the side effects, risks and benefits of a drug or treatment.

Before you decide whether a clinical trial is right for you, make sure you know the facts. Clinical trials offer a lot of hope for many people with cancer. Nearly all of the cancer-fighting drugs and treatments currently available to patients exist because they were thoroughly tested in clinical trials. The best way to ensure you are making the right choice, is taking the time to get as much information as you need to help make that decision

Below is a list of available clinical trials and cancer research opportunities through Alpha. Please talk with your doctor to discuss the treatment options available to you and their likely impact on your disease and quality of life.

Lung Cancer

A Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) with or without Pembrolizumab (MK-3475) in Participants with Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (KEYNOTE-867)
Condition or Disease: Non-Small Cell Lung Cancer
Phase: III
Study Drug: Pembrolizumab / Placebo
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

A Study of Pembrolizumab (MK-3475) in Combination with Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib vs Concurrent Chemoradiation Therapy Followed by Durvalumab in Participants with Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer (NSCLC)
Condition or Disease: Non-Small Cell Lung Cancer
Phase: III
Study Drug: Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib vs Concurrent Chemoradiation Therapy Followed by Durvalumab
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

A Multi-Arm (basket) Trial Investigating the Safety and Efficacy of IO102-IO103 in Combination with Pembrolizumab, as First-line Treatment for Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC), Squamous Cell Carcinoma of Head and Neck (SCCHN), or Metastatic Urothelial Bladder Cancer (mUBC)
Condition or Disease: Non-Small Cell Lung Cancer
Phase: II
Study Drug: IO102-IO103 in Combination with Pembrolizumab
Sponsor: IO Biotech ApS

A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) or Placebo in Combination with Chemotherapy (Carboplatin/Cisplatin-Etoposide) and Concurrent Radiotherapy in Patients with Limited-Stage Small Cell Lung Cancer (LS-SCLC)
Condition or Disease: Small Cell Lung Cancer
Phase: III
Study Drug: HLX10 or Placebo in Combination with Chemotherapy (Carboplatin/Cisplatin-Etoposide) and Concurrent Radiotherapy
Sponsor: Shanghai Henlius Biotech, Inc.

A Randomized, Open-label Study of HLX10 plus Chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus Chemotherapy in Previously Untreated US Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Condition or Disease: Small Cell Lung Cancer
Phase: III
Study Drug: HLX10 plus Chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus Chemotherapy
Sponsor: Shanghai Henlius Biotech, Inc.