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Genomic Screening

Targeted Therapy Screening for Lung Cancer

Phase 2 & 3
Recruiting
Research Sponsored by Southwest Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have adequate tumor tissue available, defined as ≥ 20% tumor cells and ≥ 0.2 mm3 tumor volume.
Patients must have pathologically proven non-small cell lung cancer (all histologic types) confirmed by tumor biopsy and/or fine-needle aspiration. Disease must be Stage IV as defined in Section 4.0, or recurrent.
Must not have
Patients with known EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS 1 gene rearrangement, or BRAF V600E mutation are not eligible unless they have progressed following all standard of care targeted therapy.
Patients with a history of any lymphoproliferative disorder or active malignancy, or cancer within 5 years prior to screening (exceptions for basal cell carcinoma and squamous cell carcinoma) are excluded.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Summary

This trial will test new targeted cancer therapies against standard of care therapy in order to find more effective treatments.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects depend on the sub-study and therapy received, common issues may include reactions related to immune system activation, typical chemotherapy side effects like nausea and fatigue, as well as potential impacts from novel targeted drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor is large enough and has enough cancer cells for testing.
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My lung cancer is confirmed and is either stage IV or has come back.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have specific genetic mutations but have progressed after all standard treatments.
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I have not had cancer or lymphatic system disorders in the last 5 years, except for certain skin cancers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Screening Success (Adequate Tissue)
Screening Success (Assignment Success)
Screening Success (Match to Biomarker-Driven Sub-Study)
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lung-MAP ScreeningExperimental Treatment1 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.

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
251,261 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
395 Previous Clinical Trials
255,148 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,949,401 Total Patients Enrolled

Media Library

Screening Platform (Genomic Screening) Clinical Trial Eligibility Overview. Trial Name: NCT03851445 — Phase 2 & 3
Non-Small Cell Lung Cancer Research Study Groups: Lung-MAP Screening
Non-Small Cell Lung Cancer Clinical Trial 2023: Screening Platform Highlights & Side Effects. Trial Name: NCT03851445 — Phase 2 & 3
Screening Platform (Genomic Screening) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03851445 — Phase 2 & 3
~4538 spots leftby Jan 2029