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A master screening protocol for previously-treated non-small cell lung cancer

LUNGMAP: A Master Protocol To Evaluate Biomarker-Driven Therapies And Immunotherapies In Previously-Treated Non-Small Cell Lung Cancer (Lung-Map Screening Study)

PHASE2; PHASE3 · SWOG Cancer Research Network · NCT03851445

This study is testing a new way to screen for specific cancer markers in people with previously treated non-small cell lung cancer to see if targeted therapies can improve their treatment compared to standard care.

Quick facts

PhasePHASE2; PHASE3
Study typeInterventional
Enrollment10000 (estimated)
Ages18 Years and up
SexAll
SponsorSWOG Cancer Research Network (network)
Drugs / interventionsNivolumab, Pembrolizumab, chemotherapy
Locations1201 sites (Birmingham, Alabama and 1200 other locations)
Trial IDNCT03851445 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to establish a genomic screening method for patients with previously treated non-small cell lung cancer, allowing for the assignment to various sub-studies based on specific cancer biomarkers. Participants will be randomized to receive either new targeted therapies or standard care, with the goal of improving treatment outcomes. The study also includes non-match sub-studies for patients who do not qualify for biomarker-driven therapies. Additionally, it evaluates patient and physician attitudes regarding the return of mutation findings.

Who should consider this trial

Good fit: Ideal candidates are patients with pathologically confirmed Stage IV or recurrent non-small cell lung cancer who have previously undergone treatment.

Not a fit: Patients with early-stage non-small cell lung cancer or those who have not received prior treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to the approval of new targeted therapies for lung cancer, improving treatment options for patients.

How similar studies have performed: Other studies utilizing similar genomic screening approaches have shown promise, indicating potential success for this novel protocol.

Eligibility criteria

Show full inclusion / exclusion criteria 
5.1 Registration

Step 0:

1. Patients who need the fresh biopsy must also submit whole blood for ctDNA testing (see Section 15.3). These patients must be registered to Step 0 to obtain a patient ID number for the submission.

   Patients registered to Step 0 are not registered to the LUNGMAP protocol. To participate in LUNGMAP, patients must be registered to Step 1 after evaluation of patient eligibility, including tumor tissue adequacy, per protocol Section 5.1, Step 1.

   Patients registered at Step 0 must use the same SWOG patient ID for registration at Step 1.

   Step 1:
2. 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. The primary diagnosis of non-small cell lung cancer should be established using the current WHO/IASLC-classification of Thoracic Malignancies. All histologies, including mixed, are allowed.
3. Patients must either be eligible to be screened at progression on prior treatment or to be pre-screened prior to progression on current treatment.

   These criteria are:
   1. Screening at progression on prior treatment:

      To be eligible for screening at progression, patients must have received at least one line of systemic therapy for any stage of disease (Stages I-IV) and must have progressed during or following their most recent line of therapy.
      * For patients whose prior systemic therapy was for Stage I-III disease only (i.e. patient has not received any treatment for Stage IV or recurrent disease), disease progression on platinum-based chemotherapy must have occurred within one year from the last date that patient received that therapy. For patients treated with consolidation anti-PD-1 or anti-PD-L1 therapy for Stage III disease, disease progression on consolidation anti-PD-1 or anti-PD-L1 therapy must have occurred within one year from the date or initiation of such therapy.
      * For patients whose prior therapy was for Stage IV or recurrent disease, the patient must have received at least one line of a platinum-based chemotherapy regimen or anti-PD-1/PD-L1 therapy, alone or in combination (e.g. Nivolumab or Pembrolizumab).
   2. Pre-Screening prior to progression on current treatment:

   To be eligible for pre-screening, current treatment must be for Stage IV or recurrent disease and patient must have received at least one dose of the current regimen. Patients must have previously received or currently be receiving a platinum-based chemotherapy regimen or anti-PD-1/PD-L1 therapy, alone or in combination (e.g. Nivolumab or Pembrolizumab). Patients on first-line treatment are eligible upon receiving Cycle 1, Day 1 infusion. Note: Patients will not receive their sub-study assignment until they progress and the LUNGMAP Notice of Progression is submitted.
4. Patients must have adequate tumor tissue available, defined as ≥ 20% tumor cells and ≥ 0.2 mm3 tumor volume.

   * The local interpreting pathologist must review the specimen.
   * The pathologist must sign the LUNGMAP Local Pathology Review Form confirming tissue adequacy prior to Step 1 registration.

   Patients must agree to have this tissue submitted to Foundation Medicine for common broad platform CLIA biomarker profiling, PD-L1, and c-MET IHC (see Section 15.2). If archival tumor material is exhausted, then a new fresh tumor biopsy that is formalin-fixed and paraffin-embedded (FFPE) must be obtained. Patients who need the fresh biopsy must also submit whole peripheral blood for ctDNA testing. A tumor block or FFPE slides 4-5 microns thick must be submitted. Bone biopsies are not allowed. If FFPE slides are to be submitted, at least 12 unstained slides plus an H\&E stained slide, or 13 unstained slides must be submitted. However, it is strongly recommended that 20 FFPE slides be submitted. Note: Previous next-generation DNA sequencing (NGS) will be repeated if done outside this study for sub-study assignment.

   Patients must agree to have any tissue that remains after testing retained for the use of sub-study Translational Medicine (TM) studies at the time of consent the patient is enrolled in.
5. 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. EGFR/ALK/ROS/BRAF testing is not required prior to Step 1 registration, as it is included in the Foundation One testing for screening/pre-screening.
6. Patients must have Zubrod performance status 0-1 (see Section 10.2) documented within 28 days prior to Step 1 registration.
7. Patients must be ≥ 18 years of age.
8. Patients must also be offered participation in banking for future use of specimens as described in Section 15.0.
9. Patients must be willing to provide prior smoking history as required on the LUNGMAP Onstudy Form.
10. As a part of the OPEN registration process (see Section 13.4 for OPEN access instructions) the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
11. Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
12. U.S. patients who can complete the survey and the interview by telephone or email in English must be offered participation in the S1400GEN Survey Ancillary Study if local institution's policies allow participants to receive the Amazon gift card (see Sections 15.7 and 18.5). Patients at institutions that cannot offer the survey must still participate in the main study.

Where this trial is running

Birmingham, Alabama and 1200 other locations

+1151 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Previously Treated Non-Small Cell Lung Cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.