S1400K of Lung-MAP seeks to evaluate the overall response rate with ABBV-399 (Process II) in
patients with c-MET positive SCCA.
S1400K is a biomarker-driven study for patients with Stage IV or recurrent squamous cell lung
cancer, who have c-MET positive squamous cell tumors.
•Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON
ELIGIBILITY CRITERIA as specified in S1400: A BIOMARKER-DRIVEN MASTER PROTOCOL FOR
PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER 5.1 Sub-Study Specific Disease Related
1. Patients must have been assigned to S1400I.
2. Patients must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2,
anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell
costimulation or immune checkpoint pathways.
3. Patients must not have an active, known, or suspected autoimmune disease. Patients are
permitted to enroll if they have vitiligo, type I diabetes mellitus, hypothyroidism
only requiring hormone replacement, psoriasis not requiring systemic treatment, or
conditions not expected to recur in the absence of an external trigger.
5.2 Sub-Study Specific Clinical/Laboratory Criteria
1. Patients must not have any known allergy or reaction to any component of the nivolumab
and ipilimumab formulations.
2. Patients must not have received systemic treatment with corticosteroids (> 10 mg daily
prednisone or equivalent) or other immunosuppressive medications within 14 days prior
to sub-study registration. Inhaled or topical steroids, and adrenal replacement doses
<= 10 mg daily prednisone or equivalent are permitted in the absence of active
3. Patients must not have a known positive test for hepatitis B virus surface antigen
(HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or
chronic infection. Patients with a positive hepatitis C antibody with a negative viral
load are allowed. [This criterion replaces common eligibility criteria in Section
4. Patients must not have known history of testing positive for human immunodeficiency
virus (HIV) or known acquired immunodeficiency syndrome (AIDS). [This criterion
replaces common eligibility criteria in Section 5.3n.]
5. Patients must not have interstitial lung disease that is symptomatic or disease that
may interfere with the detection or management of suspected drug-related pulmonary
6. Patients must also be offered participation in banking for future use of specimens as
described in Section 15.0.
7. Patients must have a Lipase, Amylase, TSH with reflex Free T3/T4 performed within 7
days prior to sub-study registration. Additional timepoints are noted in Section 9.0,
Study Calendar. [Note: For the Canadian sites, testing for lipase only is acceptable.]
8. Patients must not have any Grade III/IV cardiac disease as defined by the New York
Heart Association Criteria (i.e., patients with cardiac disease resulting in marked
limitation of physical activity or resulting in inability to carry on any physical
activity without discomfort), unstable angina pectoris, and myocardial infarction
within 6 months, or serious uncontrolled cardiac arrhythmia (see Section 18.1b).
1. Patients with a history of congestive heart failure (CHF) or at risk because of
underlying cardiovascular disease or exposure to cardiotoxic drug should have an
EKG and echocardiogram performed to evaluate cardiac function as clinically
2. Patients with evidence of congestive heart failure (CHF), myocardial infarction
(MI), cardiomyopathy, or myositis should have a cardiac evaluation including lab
tests and cardiology consultations as clinically indicated including EKG, CPK,
troponin, and echocardiogram.
9. Patients who can complete PRO forms in English are required to complete a pre-study
S1400I Patient Reported Outcomes (PRO) Questionnaire and a pre-study S1400I EQ-5D
Questionnaire within 14 days prior to registration (see Section 18.2 of S1400I). NOTE:
Patients enrolled to S1400I prior to 9/1/2016 are not eligible for the PRO study.