What side effects are associated with this type of intervention?

Common treatments for lung cancer, such as chemotherapy, targeted therapy, and immunotherapy, have various side effects. Chemotherapy often causes fatigue, nausea, vomiting, neutropenia, and diarrhea. Targeted therapies can lead to side effects like rash, diarrhea, and liver problems. Immunotherapy, including PD-1 and PD-L1 inhibitors, may cause immune-related adverse events such as colitis, pneumonitis, and thyroid dysfunction. These side effects can impact patients' quality of life and require careful management.

What prior FDA approvals exist?

The FDA has approved several targeted therapies and immunotherapies for the treatment of lung cancer. These include drugs targeting specific genetic mutations such as EGFR inhibitors (e.g., gefitinib, erlotinib) and ALK inhibitors (e.g., crizotinib). Immunotherapies such as PD-1 inhibitors (e.g., nivolumab, pembrolizumab) and PD-L1 inhibitors (e.g., atezolizumab) have also been approved. These treatments are designed to target specific biomarkers or immune checkpoints, similar to the approach being studied in the FirstLook™ trial, which aims to use DNA fragment evaluation for early detection and intervention in lung cancer.

What other types of research exist?

Promising alternatives to FirstLook™ for lung cancer patients include circulating tumor DNA (ctDNA) analysis, which can detect mutations such as T790M in EGFR-mutant NSCLC, and the use of next-generation sequencing (NGS) for identifying specific mutation-driven treatments. Additionally, liquid biopsy techniques and the use of advanced imaging technologies are also being explored for early detection and monitoring of lung cancer.

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Cancer Screening Test

DNA Screening Test Education for Lung Cancer Detection (FIRSTLungL301 Trial)

N/A

Recruiting

Research Sponsored by Delfi Diagnostics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if providing doctors with the FirstLook™ test increases lung cancer screening rates among patients who should be screened but aren't up to date. The test checks blood for early signs of lung cancer by analyzing DNA fragments.

Who is the study for?

This trial is for primary care practices with at least 50 patients eligible for lung cancer screening based on USPSTF guidelines, but who haven't been screened in the past 15 months. Practices should offer regular services and be able to handle data tasks. They shouldn't be part of other DELFI or early cancer detection studies.

What is being tested?

The study tests if giving doctors access to a DNA-based lung cancer screening test (DELFI) increases the number of patients getting screened compared to doctors without it. It's about seeing if this new tool can improve how often high-risk patients get checked for lung cancer.

What are the potential side effects?

Since this trial involves implementing a new diagnostic test rather than a medication or therapy, there are no direct side effects from interventions like drugs. However, any medical procedure may carry risks such as discomfort or bruising from blood draws.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Other study objectives

Proportion of CTs for lung cancer screening completed within the follow-up window compared to the proportion of screening CTs ordered prior to day 0.

Proportion of SDM visits completed by the provider and subsequent confirmation of completed LDCT in the control arm versus the proportion of completed SDM visits with an ordered and completed LDCT in the intervention arm.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm BExperimental Treatment2 Interventions

Arm B (intervention) practices will receive education on FirstLook™ and have access to order FirstLook™ at the providers' discretion;

Group II: Arm A1Active Control1 Intervention

Arm A practices will be further randomized 1:1 into two groups (A1:A2) to observe lung cancer screening standard of care. Practices in A1 will be observed.

Group III: Arm A2Active Control1 Intervention

Arm A practices will be further randomized 1:1 into two groups (A1:A2) to observe lung cancer screening standard of care. Practices in A2 will receive standard education on lung cancer screening for CME credit.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for lung cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect normal cells, leading to side effects. Targeted therapies, such as EGFR inhibitors, specifically target genetic mutations in cancer cells, leading to more precise treatment with potentially fewer side effects. Immunotherapy, including PD-1/PD-L1 inhibitors, boosts the body's immune system to recognize and attack cancer cells. The FirstLook™ trial's focus on DNA fragment evaluation aims to detect lung cancer early, potentially allowing for timely intervention with these treatments, improving outcomes and survival rates for patients.

Role of early definitive management for newly diagnosed malignant pleural effusion related to lung cancer.A Review of Recent Advances in the Treatment of Elderly and Poor Performance NSCLC.Customizing chemotherapy in non-small cell lung cancer: the promise is still unmet.