University of Kansas Medical Center

Eligibility

Eligible Ages

Over 18 Years

Eligible Genders

All

Accepts Healthy Volunteers

No

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.