Targeted Therapy Screening for Lung Cancer

Recruiting at1051 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

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

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes non-match sub-studies which will include all screened patients not eligible for any of the biomarker-driven sub-studies.

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.

What data supports the effectiveness of the treatment Screening Platform for lung cancer?

Research shows that lung cancer screening with low-dose CT scans can reduce lung cancer deaths by 20% in high-risk individuals, such as those with a significant smoking history. This suggests that early detection through screening can be effective in improving survival rates. ^{1 2 3 4 5}

Is targeted therapy for lung cancer generally safe for humans?

Targeted therapies for lung cancer, like EGFR and ALK inhibitors, have been associated with various side effects, including skin, stomach, lung, and heart issues. While many side effects are manageable, some can be serious, such as lung problems that might require stopping the treatment. It's important for doctors to monitor these side effects closely. ^{6 7 8 9 10}

How is the Targeted Therapy Screening Platform for lung cancer different from other treatments?

The Targeted Therapy Screening Platform for lung cancer is unique because it focuses on identifying specific genetic mutations in the cancer cells, allowing for the use of targeted drugs that are more effective and have fewer side effects compared to traditional chemotherapy. This approach uses advanced molecular biology techniques to match patients with the most suitable targeted therapies based on their tumor's genetic profile. ^{11 12 13 14 15}

Research Team

Hossein Borghaei

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Screening Platform (Genomic Screening)

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.

Participant Groups

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+

Dr. Lyudmila Bazhenova

Southwest Oncology Group

Chief Medical Officer since 2021

MD from University of California, San Diego

Dr. Richard Schilsky

Southwest Oncology Group

Chief Executive Officer since 2013

MD from University of California, San Diego

SWOG Cancer Research Network

Lead Sponsor

Trials

403

Recruited

267,000+

Dr. Charles D. Blanke

SWOG Cancer Research Network

Chief Executive Officer since 2012

MD from Oregon Health & Science University

Dr. Dawn Hershman

SWOG Cancer Research Network

Chief Medical Officer since 2020

MD from Columbia University

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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

A Multilevel Approach to Investigate Relationships Between Healthcare Resources and Lung Cancer. [2023]

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

Early detection of lung cancer in Czech high-risk asymptomatic individuals (ELEGANCE): A study protocol. [2023]

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

Reviewing Lung Cancer Screening: The Who, Where, When, Why, and How. [2019]

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

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

5. England pubmed.ncbi.nlm.nih.gov

Early detection of lung cancer. [2022]

6. Switzerland 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. [2023]

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

Safety Monitoring Activity During EGFR or Anaplastic Lymphoma Kinase Inhibitor Therapy for Patients With Lung Cancer. [2023]

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

Discovering Associations of Adverse Events with Pharmacotherapy in Patients with Non-Small Cell Lung Cancer Using Modified Apriori Algorithm. [2022]

9. Ireland 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. [2020]

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Pulmonary toxicity in driver gene positive non-small cell lung cancer therapy. [2022]

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Lung cancer. [2021]

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Targeted therapies for lung cancer: clinical experience and novel agents. [2023]

15. Germany pubmed.ncbi.nlm.nih.gov

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