Status and phase
Conditions
Treatments
About
The purpose of this study is to closely examine tumor and blood samples from patients treated with nivolumab and ipilimumab in order to try to identify why some patients with lung cancers respond and why some patients do not.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Patient must be capable, willing, and able to provide written, informed consent.
≥ 18 years old.
Advanced stage NSCLC
Previously treated with no more than two lines of prior systemic therapy for advanced stage lung cancer.
Patients must:
ECOG performance status of 0-1.
Adequate hematologic, renal, and/or hepatic function (following criteria must be met within 28 days of C1D1:
There is no restriction on the number of prior lines of systemic anti-cancer therapy. For those who have received prior systemic anti-cancer therapy, there must be at least 3 weeks since last systemic therapy.
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 3 days prior to the start of study drug.
Effective contraception:
Exclusion criteria
Patients who are pregnant or lactating.
Presence of activating EGFR mutations or ALK re-arrangement,unless previously treated with standard TKI therapy. All patients with adenocarcinoma histology must be tested for EGFR and ALK status.
History of allergy to study drug components or history of severe hypersensitivity reaction of any monoclonal antibody.
Prior treatment with immune checkpoint inhibitor, including (but not limited to) those targeting PD-1, PD-L1, PD-L2, CTLA-4, CD137, GITR, TIM3, LAG3, or OX40
Any systemic anti-cancer therapy within 3 weeks prior to C1D1 of study therapy
Exception is made for patients with EGFR or ALK re-arrangements who must have stopped TKI therapy at least 7 days prior to C1D1
Patients who have not previously been treated with platinum-based based doublet chemotherapy and who, in the judgment of the investigator, have rapidly progressive disease such that serious complications may arise from disease progression within the next 12 weeks will be excluded.
Non-CNS radiotherapy within 1 week prior to C1D1 of study therapy
Active infection requiring therapy
Prior systemic immunosuppressive therapy (> 10 mg/day prednisone equivalents) within 1 week prior to C1D1 of study therapy. Inhaled, ocular, intra-articular, intranasal, and topical corticosteroids are permitted in absence of active autoimmune disease.
Patients with known or suspected history of autoimmune disease. Subjects with type I diabetes melitis, hypothyroidism only requiring hormone replacement, resolved childhood asthma/atopy, patients with asthma requiring intermittent bronchodilator therapy, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
Other active malignancy requiring concurrent intervention.
Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless definitive therapy has been completed at least 1 year prior to study entry and the patient is now without evidence of disease from that malignance and no additional therapy is required or anticipated to be required during the study period.
Known untreated brain or leptomeningeal metastasis.
o Patients with brain metastases are eligible if metastases have been adequately treated and neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least two weeks prior to C1D1. In addition, must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration.
Patients with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.
Any positive test for HIV
Any positive test for HCV RNA or HBsAg.
Primary purpose
Allocation
Interventional model
Masking
29 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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