Lung-MAP 3.0: The Next Generation

Originally limited to patients with squamous cell lung cancer, in 2019 the trial expanded to include all histologies (Lung-MAP 2.0). Over its 10 years, it has activated 19 sub-studies, testing numerous new treatments, and has provided genomic testing for thousands of patients who otherwise would not have had it.

It has been opened at more than 1,000 sites, enrolled more than 1,000 patients to treatment sub-studies, tested multiple drug combinations, targeted 15 genetic alterations, and generated many dozens of conference presentations and manuscripts.

It has served as a training ground for engaging junior investigators in NCTN clinical trials, produced a wealth of translational medicine insights, and spawned our S2302 Pragmatica-Lung trial.

It remains a unique public–private partnership, built on close collaboration among the NCI, Friends of Cancer Research, the Foundation for the NIH, SWOG, the Alliance, ECOG-ACRIN, NRG, roughly a dozen advocacy organizations, and numerous industry partners.

During Lung-MAP’s first decade, next-generation sequencing (NGS) of patient tissue for the trial was done almost exclusively using the Foundation Medicine assay. The approach worked wonderfully (still does), and more than 5,000 patients with advanced NSCLC have been screened in this way.

Lung-MAP’s third generation
Today, though, NGS testing has become a standard part of the treatment process for most patients with NSCLC, in part because of the success of trials such as Lung-MAP, and many patients come to the study having already had genetic testing performed on their tumors, using any one of several tests now available.

Given the number of NGS testing options out there, Lung-MAP’s latest revision (technically protocol revision 9) expands the range of NGS platforms that can be used with the trial. Many patients can now be matched to Lung-MAP biomarker-driven sub-studies based on results of their past genomic testing, without needing to submit new tumor or blood samples.

Which testing platforms are accepted? Almost any CLIA-certified NGS test that is sufficiently broad, meaning it tests for all tumor genetic alterations of interest to Lung-MAP.

For starters, the Lung-MAP team has identified an initial set of 40 labs, both academic and commercial, whose NGS tests meet the trial’s criteria. The current list is linked from swog.org/lung-map-resources.

If your patient has previous results from one of these tests, you can submit those results at the time of disease progression to have the patient assigned to an appropriate sub-study. The tests already on the list cover the vast majority of testing done on patients with NSCLC.  

And if your patient’s previous test is not on the list, you can email the results, along with documentation of which alterations are included in the test, to lungmapNGS-at-swog.org. The Lung-MAP translational medicine team is committed to trying to give you an answer within a day or so as to whether the test meets Lung-MAP’s requirements.

The list of approved tests (which will be added to regularly) also includes a rundown of the genomic alterations an NGS testing result must report on – either the presence or the absence of each alteration – to be allowable.

Although the trial now accepts results from other tests, it also still offers on-study testing using the FoundationOne platform – still at no cost to the patient.

If your patient has not had previous testing, you can still submit a tissue sample for testing and sub-study assignment – either for pre-screening a patient during their first-line therapy, or at time of disease progression.

The Lung-MAP 3.0 changes make the trial more pragmatic and streamlined – sites can rely on the NGS platform they already use, and there is probably no need to submit additional tissue if a patient’s results are already in.

The revision greatly simplifies the screening process, and it should make it easier to open and enroll to the trial, making Lung-MAP’s sub-studies of new lung cancer treatments available to even more patients at a wider range of community-based treatment sites.

It’s a trial that is already well-known for its efforts and success in enrolling a representative group of patients. Easier screening puts it in an even better position to enroll patients fully representative of the U.S.’s diverse population of patients with advanced NSCLC.

Why has Lung-MAP made this change? Because our member sites asked for it. Many let us know that being required to submit tissue for one specific test was increasingly becoming a barrier to enrolling patients – or to participating in the trial at all. 

Please activate the Lung-MAP revision! And, if you haven’t had the trial open, this could be a good time to revisit that possibility. 
 

Lung-MAP’s newest biomarker sub-study, S1900J, opened just before our Chicago group meeting. The trial’s next activation – the S1800E non-match sub-study – is expected to go live by the end of the year.