Project PEER: Understanding the Lung Cancer Patient ExperiEnce

(PEER Trial)

Recruiting at 15 trial locations

Overseen By Bellinda King-Kallimanis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: LUNGevity Foundation

Disqualifiers: Under 18, Healthcare providers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

1300 Participants Needed

Trial Summary

What is the purpose of this trial?

LUNGevity Foundation, a non-profit lung cancer organization, wants to learn about living with lung cancer from the point of view of people with lung cancer and their family and friends who provide care. To do this, we have an online study designed to better understand how treatments people living with lung cancer receive impact their quality of life. Participants will complete surveys once a month for 12 months. What does participation involve? 1. Emailing the study team to learn more and get access to the study website. 2. Once a month for 12 months you will receive a survey by email. 3. Complete these surveys on a smartphone, tablet, or computer at your convenience and receive an e-gift card for your time.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on surveys about your experience with lung cancer, so you likely won't need to change your medication routine.

How is the drug Lynparza unique for treating lung cancer?

Lynparza is unique because it is a targeted therapy that works by interfering with cancer cell DNA repair, which is different from traditional chemotherapy that kills rapidly dividing cells. This mechanism can lead to fewer side effects and is particularly beneficial for patients with specific genetic mutations. ^{1 2 3 4 5}

Research Team

Upal Basu Roy, PhD, MPH

Principal Investigator

LUNGevity Foundation

Eligibility Criteria

This study is for individuals with lung cancer, including those with a specific type called lung carcinoid tumor, as well as their caregivers. Participants should be willing to share their experiences through monthly online surveys over the course of a year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Survey

Participants complete an initial baseline survey to provide data on their diagnostic and treatment experiences

1 week

1 survey (online)

Monthly Surveys

Participants receive and complete monthly surveys to report on their quality of life and treatment experiences

12 months

12 surveys (online)

Follow-up

Participants are monitored for any additional insights or data collection after the main survey period

4 weeks

Treatment Details

Interventions

• Online Study

Trial Overview There are no medical treatments being tested in this trial. Instead, participants will complete online surveys designed to gather information on how living with lung cancer affects quality of life from both patients' and caregivers' perspectives.

Participant Groups

Group I: Patients Experimental Treatment 1 Intervention

Individuals who have been diagnosed with lung cancer. Individuals with all stages of lung cancer and individuals who have reached no evidence of disease (NED).

Group II: Caregivers Experimental Treatment 1 Intervention

Family and friends who provide care for someone who has been diagnosed with lung cancer

Online Study is already approved in European Union, United States for the following indications:

Approved in European Union as Lynparza for:

• Breast cancer
• Ovarian cancer
• Fallopian tube cancer
• Peritoneal cancer
• Pancreatic cancer
• Prostate cancer
• Endometrial cancer

Approved in United States as Lynparza for:

• Ovarian, fallopian tube, and primary peritoneal cancer
• Breast cancer
• Prostate cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

LUNGevity Foundation

Lead Sponsor

Trials

8

Recruited

1,600+

Novartis

Industry Sponsor

Trials

1,646

Recruited

2,778,000+

Vasant Narasimhan

Novartis

Chief Executive Officer since 2018

MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government

Shreeram Aradhye

Novartis

Chief Medical Officer since 2022

MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania

Amgen

Industry Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Blueprint Medicines Corporation

Industry Sponsor

Trials

31

Recruited

6,000+

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Boehringer Ingelheim

Industry Sponsor

Trials

2,566

Recruited

16,150,000+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

G1 Therapeutics, Inc.

Industry Sponsor

Trials

22

Recruited

3,300+

Takeda

Industry Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Findings from Research

A survey of 292 non-small cell lung cancer (NSCLC) patients across Europe revealed that many patients have limited knowledge about biomarker testing, which is crucial for personalized treatment options, with 23% indicating no knowledge at all.

Patients reported significant emotional burdens, such as fear, anxiety, and depression, alongside a strong desire for more information and support regarding their treatment and financial impacts, highlighting the need for improved patient education and resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient perception of burden of disease and treatment preferences in non-small cell lung cancer: Results from a European survey. Tufman, A., Redmond, K., Giannopoulou, A., et al.[2022]

In a study involving 23 patients with advanced non-small-cell lung cancer, common side effects of osimertinib treatment included coughing, itching, and tiredness, with shortness of breath and diarrhea becoming more prevalent after 4 months.

Despite experiencing side effects, patients reported high satisfaction with osimertinib and found it relatively easy to cope with these side effects, suggesting that the benefits of the treatment may outweigh the challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Experience of Symptoms and Side Effects when Treated with Osimertinib for Advanced Non-Small-Cell Lung Cancer: A Qualitative Interview Substudy. Rydén, A., Blackhall, F., Kim, HR., et al.[2022]

A study involving 40 patients with newly diagnosed lung cancer showed that volunteer lay navigators provided crucial emotional support and practical information, significantly benefiting patients and their families during the transition from diagnosis to treatment.

Patients reported high satisfaction with the navigation program, indicating that volunteer support can effectively address their diverse needs with minimal resources, enhancing access to services and improving overall patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The experience of people with lung cancer with a volunteer-based lay navigation intervention at an outpatient cancer center. Lorhan, S., Dennis, D., van der Westhuizen, M., et al.[2014]

A qualitative study involving 20 participants with metastatic non-small cell lung cancer (NSCLC) revealed significant physical and psychological challenges faced by long-term survivors on immunotherapy and targeted therapy, including chronic toxicities and anxiety about cancer progression.

The study highlighted the need for tailored support and information for NSCLC survivors, as a 'one-size-fits-all' approach is inadequate; specific resources addressing long-term effects and psychological concerns are essential for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Living with and beyond metastatic non-small cell lung cancer: the survivorship experience for people treated with immunotherapy or targeted therapy. Lai-Kwon, J., Heynemann, S., Flore, J., et al.[2021]

A novel decision support intervention (DSI) for patients with late-stage non-small cell lung cancer (NSCLC) was developed, which includes care plan cards and a patient preference tool to facilitate shared decision making about treatment options.

Pilot testing with five patients showed that using the DSI increased awareness of treatment options and their benefits/risks, while reducing concerns about treatment costs and decision-making uncertainty, indicating its potential effectiveness in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging Patients with Late-Stage Non-Small Cell Lung Cancer in Shared Decision Making about Treatment. Myers, RE., Advani, SM., Myers, P., et al.[2021]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Patient perception of burden of disease and treatment preferences in non-small cell lung cancer: Results from a European survey. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Patient Experience of Symptoms and Side Effects when Treated with Osimertinib for Advanced Non-Small-Cell Lung Cancer: A Qualitative Interview Substudy. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

The experience of people with lung cancer with a volunteer-based lay navigation intervention at an outpatient cancer center. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

Living with and beyond metastatic non-small cell lung cancer: the survivorship experience for people treated with immunotherapy or targeted therapy. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Engaging Patients with Late-Stage Non-Small Cell Lung Cancer in Shared Decision Making about Treatment. [2021]