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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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

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

Primary study objectives

Screening Success (Adequate Tissue)

Screening Success (Assignment Success)

Screening Success (Match to Biomarker-Driven Sub-Study)

+3 more

Awards & Highlights

No Placebo-Only Group

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

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.

0 / 5Eligibility criteria met