Targeted Therapy Screening for Lung Cancer

Recruiting at 1076 trial locations

Overseen By Eric C. McGary

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Southwest Oncology Group

Must be taking: Platinum-based chemotherapy, Anti-PD-1/PD-L1

Disqualifiers: EGFR mutations, ALK fusion, ROS1 rearrangement, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

10000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new treatments for advanced lung cancer by matching patients to therapies based on specific cancer traits (biomarkers). Participants may receive a treatment aimed at stopping cancer growth or a standard therapy to determine which is more effective. The trial seeks individuals with Stage IV or recurrent non-small cell lung cancer who have previously tried certain treatments but need new options. Participants should have sufficient tumor tissue for testing and be willing to provide samples for future research. As a Phase 2 trial, this study measures the treatment's effectiveness in an initial, smaller group, offering participants early access to potentially effective therapies.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that patients can be pre-screened while still on their current treatment for Stage IV or recurrent disease.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that targeted cancer treatments can be safe and generally well-tolerated, as earlier studies have indicated. These treatments block the growth and spread of cancer by focusing on specific traits of the cancer cells. Patients in past studies have experienced side effects that are usually manageable.

This trial is in Phase 2/3, indicating some evidence of general safety, but researchers continue to gather more information to fully understand their safety profile.

If a treatment in the trial has FDA approval for another condition, it has passed safety checks for that use. However, its safety for lung cancer remains under study. Discussing any concerns with a healthcare professional before joining a trial is always advisable.

Why are researchers excited about this trial?

Researchers are excited about the Lung-MAP Screening because it offers a personalized approach to lung cancer treatment. Unlike traditional treatments that follow a one-size-fits-all model, this screening method identifies specific genetic markers in a patient's cancer. This allows doctors to assign patients to targeted sub-studies that are tailored to their unique tumor characteristics. By matching treatments to the genetic profile of the cancer, it has the potential to improve outcomes and reduce unnecessary side effects, providing a more efficient and effective way to tackle lung cancer.

What evidence suggests that this trial's treatments could be effective for lung cancer?

Studies have shown that targeted therapies effectively treat lung cancer by focusing on specific genetic changes in cancer cells. These treatments block cancer growth and spread by targeting these genetic traits. Research indicates that patients with certain genetic markers, known as biomarkers, respond better to targeted treatments than to traditional therapies. Initial findings suggest that genomic screening can identify these markers, allowing for more personalized and potentially more effective treatment plans. This trial involves the Lung-MAP Screening, which aims to improve treatment outcomes by matching the right therapy to the right patient based on their cancer's unique genetic profile.

Who Is on the Research Team?

Hossein Borghaei

Principal Investigator

SWOG Cancer Research Network

Are You a Good Fit for This Trial?

This trial is for adults with Stage IV or recurrent non-small cell lung cancer who've progressed after treatment. They must have a good performance status, adequate tumor tissue for testing, and consent to genomic screening. It's not open to those outside the US or with certain genetic mutations unless they've exhausted standard therapies.

Inclusion Criteria

My tumor is large enough and has enough cancer cells for testing.

My lung cancer is confirmed and is either stage IV or has come back.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I have not had cancer or lymphatic system disorders in the last 5 years, except for certain skin cancers.

I have specific genetic mutations but have progressed after all standard treatments.

Patients living outside the US are excluded.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 3 years

Multiple visits as needed for specimen submission and evaluation

Biomarker Analysis

Patient specimens are tested to determine eligibility for biomarker-driven and non-matched sub-studies

Varies based on specimen processing

Sub-study Assignment

Participants are assigned to a sub-study based on biomarker results

Immediate upon biomarker result availability

Follow-up

Participants are monitored for safety and effectiveness after sub-study assignment

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Screening Platform

Trial Overview The Lung-MAP protocol tests new targeted cancer therapies based on specific biomarkers against standard care. Participants' cancer traits determine their sub-study assignment in this phase II/III trial aiming to approve new treatments through a genomic screening platform.

How Is the Trial Designed?

Group I: Lung-MAP Screening Experimental Treatment 1 Intervention

This is a screening study and does not have an intervention. LUNGMAP is an overarching umbrella study to which patients are screened and then assigned to a treatment sub-study. The treatment sub-studies are standalone trials and have their own NCT numbers. The Lung-MAP Study is considered a single study under one IND, consisting of the Screening Protocol and multiple sub-studies. Each sub-study protocol operates independently and has its own version date.

Who Is Running the Clinical Trial?

Southwest Oncology Group

Lead Sponsor

Trials

389

Recruited

260,000+

SWOG Cancer Research Network

Lead Sponsor

Trials

403

Recruited

267,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A better understanding of the molecular basis of non-small cell lung carcinoma (NSCLC) is crucial for developing new targeted therapies, as it helps identify key biomarkers related to disease progression.

Recent advancements have identified new molecular abnormalities in genes like EGFR, HER2, and BRAF, which are being targeted in clinical trials for innovative treatments, enhancing the potential for personalized medicine in NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[NSCLC and new oncogenic mutations: Diagnosis and perspectives]. Basse, C., Swalduz, A., Mc Leer, A., et al.[2021]

In a study involving 179 patients with advanced lung adenocarcinoma and sensitive EGFR mutations, the combination of icotinib with chemotherapy significantly improved progression-free survival (PFS) compared to icotinib alone, with PFS of 16.0 months versus 10.0 months.

While the combination therapy increased the incidence of severe side effects like leukopenia and liver function damage, these adverse events were generally manageable, indicating that the benefits of improved PFS may outweigh the risks for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination of icotinib and chemotherapy as first-line treatment for advanced lung adenocarcinoma in patients with sensitive EGFR mutations: A randomized controlled study. Xu, L., Qi, Q., Zhang, Y., et al.[2020]

Randomized controlled trials of lung cancer screening show improved disease stage and survival rates in screened individuals, but no significant difference in mortality compared to unscreened populations, indicating that screening may lead to overdiagnosis.

The study suggests that the excess number of cancer cases detected through screening is likely due to overdiagnosis, where cancers that would not have caused harm are identified, a phenomenon also observed in other cancer screening programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung cancer screening: improved survival but no reduction in deaths--the role of "overdiagnosis". Parkin, DM., Moss, SM.[2019]

The National Lung Screening Trial (NLST) showed that low-dose CT (LDCT) screening can reduce lung cancer mortality by 20%, leading to guidelines that recommend annual LDCT for high-risk individuals.

While LDCT screening is promising, there are concerns about false positives, costs, incidental findings, radiation exposure, and overdiagnosis, prompting ongoing studies to enhance screening methods and patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early detection of lung cancer. Midthun, DE.[2022]

In a study of 16,527 non-small cell lung cancer patients, the most common adverse events linked to pharmacotherapy were hypocalcemia, elevated creatine phosphokinase, and hypertriglyceridemia, highlighting the need for monitoring these conditions during treatment.

The modified Apriori algorithm proved to be more effective than the conventional method in identifying associations between chemotherapy drugs and adverse events, suggesting it could be a valuable tool for improving patient safety in cancer pharmacotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discovering Associations of Adverse Events with Pharmacotherapy in Patients with Non-Small Cell Lung Cancer Using Modified Apriori Algorithm. Chen, W., Yang, J., Wang, HL., et al.[2022]

Lung cancer remains a major global health challenge, with 2 million new cases and 1.76 million deaths annually, highlighting the urgent need for effective treatments.

Recent advancements in understanding lung cancer biology, along with the use of predictive biomarkers and targeted therapies, have significantly improved screening, diagnosis, and treatment outcomes for patients, particularly with non-small-cell and small-cell lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung cancer. Thai, AA., Solomon, BJ., Sequist, LV., et al.[2021]

Targeted therapies for non-small cell lung cancer (NSCLC) have significantly improved treatment options, but their effectiveness can be compromised by issues like poor patient adherence and adverse events.

The review highlights the need for standardized monitoring protocols for the various toxicities associated with these therapies, which can include skin, gastrointestinal, lung, and heart-related side effects, to ensure better patient management and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted Toxicities: Protocols for Monitoring the Adverse Events of Targeted Therapies Used in the Treatment of Non-Small Cell Lung Cancer. Hines, JB., Bowar, B., Levine, E., et al.[2023]

Lung cancer has a very low 5-year survival rate of 8-16% when diagnosed at an advanced stage, but early detection can significantly improve survival rates to as high as 67% with appropriate treatments.

Current screening methods, including sputum cytology and newer biomarker technologies, show promise for early detection of lung cancer, but no single method has yet proven effective in reducing mortality in large studies, highlighting the need for further research on optimal screening strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of novel biological tools used in screening for the early detection of lung cancer. Ghosal, R., Kloer, P., Lewis, KE.[2015]

Recent advancements in lung cancer treatment include the use of molecularly targeted therapies, such as monoclonal antibodies and tyrosine kinase inhibitors, which are generally better tolerated and more effective than traditional chemotherapy.

Targeted therapies that focus on specific genetic mutations, like those in the epidermal growth factor receptor and anaplastic lymphoma kinase, have received FDA approval and show significant promise when combined with a thorough understanding of patient-specific factors and tumor biology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted therapies for lung cancer: clinical experience and novel agents. Larsen, JE., Cascone, T., Gerber, DE., et al.[2023]

Lung cancer is a key area for advancing personalized medicine through the identification of predictive biomarkers that can guide treatment decisions for conventional therapies and new targeted drugs.

The review emphasizes the need for efficient testing strategies and technical methods to handle the challenges posed by limited tissue samples in lung cancer diagnostics, ensuring accurate patient stratification for optimal treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Molecular diagnostics of non-small cell lung cancer: New markers and technologies]. Warth, A., Endris, V., Kriegsmann, M., et al.[2018]

Molecular targeted therapy for non-small cell lung cancer (NSCLC) significantly enhances treatment efficacy in patients with driver gene mutations, but it can also lead to serious pulmonary toxicities, including interstitial lung disease, in a small percentage of patients.

Prompt recognition and management of drug-related lung injuries are crucial, as these toxicities can be life-threatening and may require discontinuation of therapy; however, current understanding of their pathophysiology and management is still limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary toxicity in driver gene positive non-small cell lung cancer therapy. Zhao, YP., Long, Y.[2022]

Annual low-dose CT screening for lung cancer significantly reduces mortality in high-risk individuals, specifically those aged 55-74 with a smoking history of over 30 pack-years.

Effective lung cancer screening requires a comprehensive approach that includes personalized risk assessment, shared decision-making, and a multidisciplinary care team to manage potential risks like overdiagnosis and anxiety from indeterminate findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reviewing Lung Cancer Screening: The Who, Where, When, Why, and How. Bade, BC., Brasher, PB., Luna, BW., et al.[2019]

In New York state, nearly half (48.3%) of lung cancer patients were diagnosed with late-stage disease, highlighting the need for improved access to lung cancer screening resources, especially in rural areas.

The study found that rural counties had fewer lung cancer screening centers and higher lung cancer mortality rates, indicating that geographic disparities in healthcare resources significantly impact patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multilevel Approach to Investigate Relationships Between Healthcare Resources and Lung Cancer. Somayaji, D., Seo, YS., Wilding, GE., et al.[2023]

The ELEGANCE study in the Czech Republic aims to optimize lung cancer screening for high-risk individuals using low-dose CT (LDCT), targeting those aged 55 to 74 with significant smoking histories, to increase the detection of cancers at a resectable stage.

The study protocol includes careful monitoring of radiation exposure during LDCT and employs advanced techniques like nodule volumetry to assess cancer risk, with the goal of improving early diagnosis and evaluating the cost-effectiveness of the screening program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early detection of lung cancer in Czech high-risk asymptomatic individuals (ELEGANCE): A study protocol. Lambert, L., Janouskova, L., Novak, M., et al.[2023]

A study of 130 treatment courses in 111 patients revealed that safety monitoring activities (SMAs) for EGFR and ALK inhibitors were inconsistently conducted, with prevalence ranging from 10.0% to 84.6%, and 31.5% of courses had no SMAs performed.

EGFR inhibitors were associated with a higher likelihood of SMAs being conducted compared to ALK inhibitors, highlighting the need for clinicians to closely follow FDA guidelines to ensure patient safety and monitor for serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Monitoring Activity During EGFR or Anaplastic Lymphoma Kinase Inhibitor Therapy for Patients With Lung Cancer. Singh, AM., Rubiera-Pebe, R., Ahmad, Y., et al.[2023]

Citations