POISE (Patient-centered, Optimal Integration of Survivorship and Palliative Care) study at Massachusetts General Hospital for patients with advanced lung cancer receiving targeted therapy including RET cancer patients.

New targeted treatments have helped people with advanced lung cancer live longer and have fewer symptoms, but patients still face a long and unpredictable illness, often with needs for support that aren’t fully met. Many struggle with worries about the future, unclear information about their prognosis, and misunderstandings about whether their cancer can be cured. While early palliative care can help patients feel better, cope with their illness, and communicate with their doctors, past studies were done before modern targeted therapies, so it’s unclear how best to support patients who may live longer with advanced cancer. Survivorship care, which usually focuses on people who have finished early-stage cancer treatment, can also help by supporting long-term health, lifestyle changes, and emotional well-being. To meet these needs, researchers developed POISE (Patient-centred, Optimal Integration of Survivorship and palliative carE), a short program combining palliative and survivorship care for patients with advanced lung cancer receiving targeted therapy for tumors harboring EGFR, ALK, ROS1 or RET mutations. POISE is designed to help patients manage emotions, understand their illness, communicate with their care team, and take care of their long-term health. This study describes whether POISE is practical, helpful, and acceptable to patients compared with usual care.

POISE includes four sessions (60 minutes) with a trained palliative care clinician, either in person or by video, to help patients cope with their illness, understand their prognosis, set goals, and manage their long-term health. Participants will also complete short surveys about their feelings, quality of life, and health management. Half of the participants will receive POISE, and the other half will receive usual care from their oncology team. The study aims to see if POISE is helpful, easy to use, and acceptable to patients, and the results will help doctors improve supportive care for people living with advanced lung cancer.

Current trial status

Recruitment and enrolment for the RCT began on 21 November 2024. Any changes to the status of the trial will be updated on ClinicalTrials.gov (trial registration number: NCT04900935).

Other clinical trials

View other RET clinical trials.

 

Learn more about RET Research

Clinical study for patients with RET+ solid tumors

EP0031 is a new specific RET inhibitor with broad activity against common RET fusions and mutations, including RET mutations that confer resistance to the RET inhibitors selpercatinib or pralsetinib and great brain penetration.

More info:

Infographic PDF

https://clinicaltrials.gov/study/NCT05443126

2025 ASCO RET highlights

 

Match to a clinical trial
Learn more about RET research

A lung cancer clinical trial is a type of clinical study conducted to test new medical treatments, interventions, or approaches to diagnosing or managing lung cancer. Clinical trials are a critical part of medical research and the process of bringing new therapies to patients. They are designed to determine the safety, efficacy, and potential side effects of experimental treatments or to compare new treatments with existing standard-of-care options.

By participating in clinical trials, patients contribute to the development of new therapies that can benefit future patients and potentially improve their own health outcomes. Clinical trials follow strict protocols and are overseen by regulatory bodies to ensure the safety and well-being of participants.

Finding Clinical Trials for RET-Positive Lung Cancer

Researching clinical trials

ClinicalTrials.gov is a free service provided by the National Institutes of Health through the National Library of Medicine where patients can find clinical studies around the world. In addition, patients can seek information about ongoing clinical trials from cancer centers and patient advocacy organizations, such as our own listing of RET clinical trials.

Determining Eligibility

Each clinical trial has specific inclusion and exclusion criteria. Discuss with your oncologist or healthcare provider to determine for which trials you may meet the criteria. Review the criteria and identify trials for which you might be eligible. Common criteria include type and stage of cancer, genetic markers (like RET-positive), age, overall health, and prior treatments.

Once eligibility is determined, participants will need to review and sign an informed consent form as part of the enrollment process. This form is crucial as it signifies that a patient is officially considered “recruited” and is ready to be screened for the trial.

Discussing Informed Consent with Your Healthcare Provider

Discuss potential trials with your oncologist or healthcare team. They can help you understand the trial’s purpose, risks, benefits, and whether it’s a good fit for your treatment plan. The principal investigator, who is responsible for conducting the trial, can provide detailed information about the trial’s purpose and management.

Some trials require a referral from a healthcare provider. Your oncologist can guide you through this process and make the necessary referrals.

Clinical Trial Enrollment

Once you’ve identified that a trial is a good fit for you, contact the trial coordinator or clinical research team. They can provide detailed information about the trial, including the screening and enrollment process. Note that the trial must be approved by an institutional review board before it can change its recruitment status to “Recruiting.”

Ask for an information packet or consent form to learn more about the trial’s objectives, procedures, duration, and participant expectations.

Initial Screenings and Assessments

Medical History Review: The trial team will review your medical history to determine whether you meet the eligibility criteria. This may include information about your cancer diagnosis, previous treatments, and other medical conditions.

Baseline Tests: If the initial review suggests you’re eligible, you will undergo a series of baseline tests. These tests may include blood work, imaging studies (like CT scans), lung function tests, and other assessments to gather information about your current health and cancer status. The trial team will collect and manage clinical trial data in compliance with regulatory requirements during these initial screenings and assessments.

Genetic Testing: For trials targeting specific genetic markers (like RET-positive), you may need genetic testing to confirm your eligibility.

Informed Consent: During the initial screenings, the trial team will discuss the informed consent process with you. This involves explaining the trial’s purpose, potential risks and benefits, procedures, and your as a participant. You will need to sign the consent form to indicate your understanding and agreement to participate.

Barriers to Clinical Trial Participation

While clinical trials offer valuable opportunities for lung cancer patients, several barriers can impede participation. Patient enrollment is a crucial phase that includes recruitment, screening, and randomization of participants. Understanding these barriers can help patients navigate and potentially overcome them. Below are some common obstacles and suggestions for addressing them.

Lack of Awareness

Many patients are unaware of clinical trials as a treatment option. This lack of knowledge can prevent patients from exploring potential trials.

Make sure to keep open communication with healthcare providers as they can provide information on lung cancer clinical trials that might be a good match. Additionally, be sure to check online resources such as ClinicalTrials.gov  and our own RET clinical trials page to search for relevant cancer clinical trials.

Eligibility Requirements

Clinical trials often have strict eligibility requirements based on factors like cancer stage, prior treatments, age, and overall health. Discuss with your doctor to determine for which trials you may meet the criteria. If ineligible for a trial, ask if there are other similar studies or if the trial criteria might change in the future.

Geographic Barriers

Clinical trials may be conducted at specific medical centers or internationally, requiring significant travel for some patients. Look for trials available at local or regional cancer centers. Some trials may offer travel assistance or reimbursement for participants who need to travel from afar.

Financial Constraints

While many clinical trial costs are covered by sponsors, participants might still face expenses for travel, accommodation, or additional medical care. Inquire about financial support programs or insurance coverage for clinical trial-related costs. Some trials may offer assistance with these expenses.

Time Commitments

Clinical trials can require significant time commitments for treatments, follow-up visits, and data collection. Evaluate your schedule and obligations. Discuss with your employer and family about potential flexibility during the trial period. Some trials may offer remote monitoring options, reducing the need for frequent visits.

Social and Emotional Barriers

Participating in a clinical trial can be stressful and emotionally taxing. The lack of a strong support system may deter some patients from participating. Build a support network with family, friends, or patient advocacy groups. In addition, some cancer centers offer counseling and support services for clinical trial participants.

Fear and Misinformation

Patients may be worried about the risks associated with clinical trial participation, experimental treatments or may encounter misinformation about clinical trials. Educate yourself on the clinical trial process, including safety measures and ethical oversight. Remember that clinical trials are overseen by a review board to ensure ethical standards and participant safety. Be sure to engage in discussions with your healthcare provider about the potential risks and benefits of participating in a trial, and seek accurate clinical trial information from reputable sources.

Resources

https://clinicaltrials.gov/

https://happylungsproject.org/current-clinical-trials/

https://www.cancer.gov/research/participate/clinical-trials/disease/non-small-cell-lung/treatment

https://www.lungcancerresearchfoundation.org/for-patients/living-with-lung-cancer/clinical-trials/

https://www.lung.org/research/clinical-trials/find-a-clinical-trial

https://www.mskcc.org/cancer-care/types/lung/clinical-trials

https://www.mdanderson.org/patients-family/diagnosis-treatment/clinical-trials.html

https://www.massgeneral.org/cancer-center/clinical-trials-and-research/search-clinical-trials?cancerCondition=Lung+Cancer

https://www.mayo.edu/research/clinical-trials/diseases-conditions/non-small-cell-lung-cancer/

Understanding RET Lung Cancer Clinical Trials

Participating in oncology clinical trials can be a vital step for many lung cancer patients, offering access to potentially life-saving treatments.

RET lung cancer is a subset of non-small cell lung cancer (NSCLC) characterized by alterations in the RET gene. The most common RET alterations in lung cancer are the abnormal re-arrangement or fusions of the RET gene with other fusion gene partners. These fusions lead to constitutive activation of the RET kinase, which produces uncontrolled cell growth and cancer.

Clinical trials for RET-targeted therapies are crucial for advancing medical research and developing effective treatments for RET lung cancer. Clinical research or clinical trials are exhaustively monitorized to ensure safety and quality of life of the cancer patients. Guaranteeing safety, protection of rights, and confidentiality of patients participating in clinical trials are key factors of good clinical practice, and ethical concerns must be considered to ensure patient safety.

Informed Consent of Clinical Trials

Informed consent is the process by which a health care provider communicates to a patient about:

• Nature of the procedure
• Risks, benefits, and alternatives to the medical procedure or treatment, genetic testing, or clinical research study
• Right to withdraw

Informed consent is essential in clinical trials practice and is both an ethical and legal obligation of medical practitioners in the U.S., allowing patients to make an informed, voluntary decision about their care.

Informed consent must be clear and easy to understand; the consent form must be given in writing and may be discussed with the doctors and nurses or the research team. A patient always has the right to withdraw from a clinical trial at any time.

References and Resources

1. 1. 1. https://www.cancer.org/cancer/managing-cancer/making-treatment-decisions/informed-consent/what-is-informed-consent.html
      2. https://www.lungevity.org/sites/default/files/request-materials/LUNGevity-clinical-trials-booklet-033115.pdf
      3. https://www.cancer.gov/research/participate/clinical-trials/what-are-clinical-trials
      4. https://www.cancer.gov/research/participate/clinical-trials/disease/non-small-cell-lung/treatment

Your donation matters. Please make a gift today to support lung cancer research and save lives.

Clinical trials play a pivotal role in advancing medical research and developing effective treatments for various diseases, including RET lung cancer. These trials are structured in phases, each serving a distinct purpose in evaluating a new treatment’s safety, efficacy, and overall impact. Let’s explore the phases of clinical trials, shedding light on what each phase entails and how clinical trials activate medical progress.

The Investigational New Drug Process

An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.

Principal investigators, drug developers, or sponsors must submit an Investigational New Drug (IND) application to the FDA before beginning a clinical trial. The request includes animal study data and toxicity, manufacturing information, clinical trial plans to be conducted, data from any prior human research, and information about the investigator.

The primary objectives in reviewing a new drug are:

• To assure the safety and rights of subjects in all phases of an investigation
• To help assure that the quality of the scientific evaluation of the drug is adequate to permit an evaluation of the drug’s effectiveness and safety in phases II and III studies

The Importance of Clinical Trial Phases

Understanding the phases of RET lung cancer clinical trials is crucial for anyone interested in the development and approval process of new treatments. Each phase serves a unique purpose, from establishing safety in Phase I to assessing long-term outcomes in Phase IV. By following this structured approach, researchers can ensure that new treatments are both safe and effective, ultimately improving the lives of patients.

Lung Cancer Clinical Trials are Critical to Advance Research

RET-positive lung cancer patient participation in clinical trials is important to reveal potential treatment options and help researchers gather critical information upon which to base their research for improved treatment options. Clinical trials also offer hope to patients and their families.

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

If you have any questions about RET lung cancer clinical trials or would like to learn more about the latest advancements in RET lung cancer research, feel free to contact us for additional information.

References

1. 1. National Cancer Institute: https://www.cancer.gov/research/participate/clinical-trials/how-trials-work
   2. https://www.cc.nih.gov/orcs/ind1.html
   3. https://www.fda.gov/patients/drug-development-process/step-3-clinical-research#:~:text=In%20most%20cases%2C%2020%20to,with%20that%20type%20of%20cancer.
   4. https://www.mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/phases-of-clinical-trials.html

Your donation matters. Please make a gift today to support lung cancer research and save lives.

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.

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

1. https://www.lungcancerresearchfoundation.org/for-patients/clinical-trials/understanding-clinical-trials/
2. https://www.cancer.gov/research/participate/clinical-trials/what-are-clinical-trials#:~:text=Clinical%20trials%20test%20new%20ways,of%20cancer%20and%20its%20treatment
3. https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/what-clinical-trials-are/phases-of-clinical-trials
4. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/institutional-review-boards-irbs-and-protection-human-subjects-clinical-trials
5. https://www.hopkinsmedicine.org/research/understanding-clinical-trials/clinical-research-team
6. https://www.cancer.gov/research/participate/clinical-trials/paying
7. https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics

Your donation matters. Please make a gift today to support lung cancer research and save lives.