Why Should You Participate in Lung Cancer Clinical Trials?

Lung cancer clinical trials offer the potential for access to cutting-edge treatments and therapies that are not yet available to the general public. This can be especially important for patients with advanced lung cancers or lung disease who have exhausted standard treatment options.

What is a Clinical Trial?

Clinical trials are monitored, scientific research studies that test new treatments or medical approaches in patients. They are aimed at testing new ways of treating cancer; new approaches or interventions like screening, radiation therapy or surgery, new combination of drugs; and how to prevent or diagnose diseases. Clinical trials are exhaustively monitored to ensure patients’ safety and maintain quality of life.

Why are Clinical Trials an Important Part of Lung Cancer Research?

Lung cancer trials are necessary to understand and test the effects of new treatments in lung cancer patients and to improve lung cancer research. Taking part in a lung cancer clinical trial adds to the collective knowledge about lung cancer and moves lung cancer research forward, which is key to improving cancer care for current and future patients. Every cancer drug, cancer treatment, or cancer intervention that is now approved by the U.S. Food and Drug Administration (FDA) was tested first in lung cancer clinical trials. Talk to your doctor and healthcare team to see which clinical trials may be appropriate for you.

Diversity is very important in clinical trials. Including participants with different living conditions and variations in race, ethnicity, age, and gender is critical so more patient groups can be represented and more patient communities can benefit from research advances.

Risks & Benefits

Potential Benefits and Risks of Joining a Lung Cancer Trial

Lung cancer clinical trials have potential risks and benefits, and it is important to discuss these with your doctor and healthcare team so you can make the best decision for your cancer care.

Clinical Trial Benefits

Potential benefits of being part of lung cancer clinical trials may include:

Access to Cutting-Edge Treatments: Clinical trials provide access to new treatments and therapies for lung cancers and lung disease before they are widely available, especially when no FDA-approved options remain.
Expert Medical Care: Participants receive close monitoring and care from leading healthcare professionals and specialists in lung cancers and advanced solid tumors.
Contribution to Medical Research: When patients participate in a clinical trial, this helps advance scientific knowledge, supports ongoing research, and enables researchers to follow the disease progression. These contributions are crucial for research institutions like the National Cancer Institute and others.
Enhanced Monitoring: Frequent and thorough check-ups can lead to early detection and management of side effects or complications related to lung cancers and tumor cell growth.
Cost Benefits: Many trials cover the costs of treatments, tests, and doctor visits, which may reduce the financial burden on participating patients.
Hope for Better Outcomes: New treatments tested in trials may offer better outcomes compared to standard treatments, especially for advanced solid tumors.
Personalized Treatment Options: Some trials focus on personalized medicine, offering treatments tailored to the specific genetic makeup of a patient’s tumor cells.
Empowerment and Active Role: Participating in a clinical trial enables patients to take an active role in their treatment and healthcare decisions, which may provide a sense of control over their lung cancer journey.
Supportive Care: Participants often receive additional resources and support services, such as counseling and patient advocacy, which can help manage the challenges of lung cancer.
Future Generations: By participating, lung cancer patients help ensure future generations have access to more effective and safer lung cancer treatments.

Clinical Trial Risks

Potential risks of being part of lung cancer clinical trials may include:

Side Effects: Clinical trials are exhaustively monitored and supervised. Participants receiving an experimental treatment may present side effects that are particular of the treatment. Side effects are carefully monitored to ensure the safety of the patients and so doctors may make decisions accordingly.
Worsened Results: A new cancer treatment or therapy may not work at all, or it may not be better than the standard treatment.

Phases

Understanding the Phases of Lung Cancer Clinical Trials

Lung cancer clinical trials that are testing new treatment options are carefully designed to investigate:

Whether cancer treatments are safe
Whether cancer treatments are effective
Whether cancer treatments are better than what is currently approved

These goals are reflected in the different phases of clinical trials:

Phase I trials test whether the new treatment is safe in patients and also the best dose (dose escalation phase). The number of participants in Phase I trials is limited to 15-50.
Phase II trials are focused on the therapeutic effect and side effects of the new treatment. The number of participants in phase II clinical trials is also less than 100.
Phase III trials are advanced trials that test whether the new treatment is better than a standard treatment. For example, phase III trials may compare survival, disease progression, or response rates of the different groups of patients treated. Phase III trials involve hundreds of patients.
Phase IV trials occur when the treatment is approved and available. The primary objective is to gather more information about the long-term benefits and side effects of the treatment. Phase IV trials involve thousands of patients.

Roles & Responsibilities

Clinical Trial Roles and Responsibilities

There are several roles involved in lung cancer clinical trials. The design and team of a clinical study may vary, but it likely includes the following key players:

Primary Investigator

The primary investigator (PI) of a clinical study is the person who is ultimately responsible for everything in the study. The PI designs and oversees all aspects of the clinical study. The PI is fully in charge of designing the clinical study concept and submits it for approval to the site’s institutional review board (IRB). Clinical studies in the U.S. must be approved by an IRB that is an independent group (doctors, scientists, etc.) and that has been formally designated to review and monitor lung cancer research involving human subjects. The purpose of the IRB review is to ensure that appropriate steps are taken to protect the rights and welfare of those participating in a clinical study. The IRB regularly reviews the study and its results.

Study Coordinator

The study coordinators work closely with the PI; they are involved in participant recruitment, and they ensure that participants understand all the requirements of the study. They explain the study to the participants and obtain consent from them. They work with the PI and others to collect patients’ clinical data from the study, and they serve as the contact person for the duration of the clinical study.

Research Coordinator and/or Nurse

The research coordinator or nurse is in close contact with patients and oversees patient care during the clinical study. They explain the details of the study to patients and also assist with treating patients. They have a key role to assist the PI, periodically reviewing any adverse events or treatment toxicities related to the clinical study.

Lung Cancer Patients

Patients or participants are the main part of clinical trials. Without participants, clinical research is not possible.

Does it Cost Money to be in a Lung Cancer Clinical Trial?

Before you join a clinical study, talk with your doctor and health care team along with the research health team to learn which costs your health plan will cover. Many clinical trial costs are covered by the sponsor of the study or a patient’s insurance plan, but sometimes there are out-of-pocket expenses.

Patient Participation and Ethical Considerations in Lung Cancer Trials

Lung cancer clinical trials must adhere to ethical guidelines to protect patients and participants and to preserve the integrity of the science. Key ethical considerations for every clinical study include:

Informed Consent: Informed consent is the process of providing information to participants about every aspect of the clinical study so they can understand the goals, risks, and benefits before deciding whether to participate. The clinical study team provides an informed consent form, which includes all the details of the study including the risks and potential benefits. Note: A clinical trial participant may withdraw from the study at any time.

Institutional Review Board (IRB) Review: The IRB periodically reviews and monitors the clinical study to ensure protection of the rights and welfare of patients. The IRB helps to ensure that clinical trials are ethical.

Find a RET-Positive Lung Cancer Clinical Trial

Clinical trials offer hope to patients – and critical information to researchers that can lead to improved treatment options.

The Happy Lungs Project offers information about the latest clinical trials for RET-positive patients. Use our tool to match to a trial.

All clinical trials are listed in ClinicalTrials.gov, and they all have an identifier number.

Talk with your doctor and medical team about the possibility of joining a non small cell lung cancer (NSCLC) or RET specific lung cancer clinical trial.

References

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