This phase III ALCHEMIST treatment trial studies how well nivolumab after surgery and chemotherapy work in treating patients with stage IB-IIIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age \>= 18 years
* Patients must have undergone complete surgical resection of their stage IB (\>= 4 cm), II or IIIA NSCLC according to the American Joint Committee on Cancer (AJCC) 7th edition and have had negative surgical margins
* Baseline chest CT must be performed within 1 month (30 days) prior to randomization to ensure no evidence of disease; if clinically indicated, additional imaging studies must be performed to rule out metastatic disease
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization
* Non-squamous tumors must not be positive for EGFR exon 19 deletion or exon 21 L858R mutation (centrally as part of the ALCHEMIST-SCREEN protocol) and ALK rearrangement (centrally as part of ALCHEMIST-SCREEN and/or locally)
* NOTE: if the results of the central EGFR testing are negative, but the ALK testing was not able to be completed by the ALCHEMIST central lab, the ALK status will be considered negative (unless locally positive for ALK rearrangement) and the patient may be considered for enrollment onto EA5142, once PD-L1 results are received and all other eligibility requirements are met
* Tumors must have PD-L1 status tested centrally as part of the ALCHEMIST-SCREEN protocol
* Women must not be pregnant or breast-feeding due to unknown and potentially harmful effects of nivolumab on the developing fetus or child
* All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse during the treatment period and for 31 weeks after the last nivolumab infusion
* Patients must NOT have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
* No prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-CTLA4 monoclonal antibody)
* Patients must have adequately recovered from thoracic surgery and any administered chemotherapy/radiotherapy at the time of randomization (NOTE: adjuvant chemotherapy and/or radiation is not required)
* Minimum time between date of surgery and randomization is 4 weeks (28 days)
* Maximum time allowed between surgery and randomization:
* 3 months (90 days) if no chemotherapy is administered
* 8 months (240 days) if adjuvant chemotherapy was administered
* 10 months (300 days) if adjuvant chemotherapy and radiation therapy was administered
* Patients must have completed and recovered from any adjuvant chemotherapy 2 or more weeks prior to randomization (6 weeks for mitomycin and nitrosoureas; 4 weeks for post-operative radiation therapy) (NOTE: adjuvant chemotherapy and/or radiation is not required)
* Serum aspartate transaminase (aspartate aminotransferase \[AST\]) and serum alanine transaminase (alanine aminotransferase \[ALT\]) =\< 2.5 x upper limit normal (within 2 weeks prior to randomization)
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) (except in subjects with Gilbert syndrome who must have a total bilirubin \< 3.0 x ULN) (within 2 weeks prior to randomization)
* White blood cell (WBC) \>= 2000/uL (within 2 weeks prior to randomization)
* Neutrophils \>= 1000/uL (within 2 weeks prior to randomization)
* Platelets \>= 100 x 10\^3/uL (within 2 weeks prior to randomization)
* Hemoglobin \>= 8 g/dL (within 2 weeks prior to randomization)
* Serum creatinine =\< 2 x ULN (within 2 weeks prior to randomization)
* Prior to randomization patients with any non-hematologic toxicity from surgery, chemotherapy and radiation therapy must have recovered to grade =\< 1 with the exception of alopecia, ototoxicity and neuropathy
* Patients must not be receiving any other investigational anti-cancer agents while on study
* Patients must not have known or suspected autoimmune disease; subjects with type I diabetes mellitus, hypothyroidism requiring hormone replacement, or skin disorders not requiring systemic treatment are permitted to enroll
* Patients must not have a condition requiring systemic corticosteroids equivalent to \> 10 mg prednisone per day or other immunosuppressive medications within 2 weeks of randomization; inhaled, intra-articular, and epidural steroids are permissible
* Patients must not have known interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
* Patients must not have a known history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection that is untreated and/or with a detectable viral load
* Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab
Primary outcome measure(s)
Disease-free survival (DFS) — Time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time, assessed up to 10 years DFS distributions will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate the treatment hazard ratios. The primary comparisons of DFS will use a logrank tests stratified on the randomization stratification factors with a one-sided type I error rate corresponding to the significance level associated with population being analyzed; that is, 1.5% for the overall population and 1% for the \>= 50% population. The latter test will only be performed in the event that the primary test in all-comers is not statistically significant. Other comparisons of groups will be made using the logrank test and Cox modeling. Point estimates of all endpoints will be accompanied by the corresponding confidence intervals adjusted for the type I error rates associated with the endpoint. Subset analyses are planned for all stratification factors and all known prognostic factors such as performance status, age, gender, etc.
Overall survival (OS) — From randomization to death from any cause, assessed up to 10 years OS distributions will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate the treatment hazard ratios. The primary comparisons of OS will use a logrank tests stratified on the randomization stratification factors with a one-sided type I error rate corresponding to the significance level associated with population being analyzed; that is, 1.5% for the overall population and 1% for the \>= 50% population. The latter test will only be performed in the event that the primary test in all-comers is not statistically significant. Other comparisons of groups will be made using the logrank test and Cox modeling. Point estimates of all endpoints will be accompanied by the corresponding confidence intervals adjusted for the type I error rates associated with the endpoint. Subset analyses are planned for all stratification factors and all known prognostic factors such as performance status, age, gender, etc.
Trial sites (884)
Facility
City
Region
Status
University of Alabama at Birmingham Cancer Center
Birmingham
Alabama
Southern Cancer Center PC-Daphne
Daphne
Alabama
Southern Cancer Center PC-Mobile
Mobile
Alabama
Southern Cancer Center PC-Providence
Mobile
Alabama
Southern Cancer Center PC-Springhill
Mobile
Alabama
Katmai Oncology Group
Anchorage
Alaska
Providence Alaska Medical Center
Anchorage
Alaska
Mayo Clinic Hospital in Arizona
Phoenix
Arizona
Mayo Clinic in Arizona
Scottsdale
Arizona
Banner University Medical Center - Tucson
Tucson
Arizona
University of Arizona Cancer Center-North Campus
Tucson
Arizona
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro
Arkansas
John L McClellan Memorial Veterans Hospital
Little Rock
Arkansas
Kaiser Permanente-Anaheim
Anaheim
California
PCR Oncology
Arroyo Grande
California
Sutter Auburn Faith Hospital
Auburn
California
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn
California
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield
California
Kaiser Permanente-Baldwin Park
Baldwin Park
California
Kaiser Permanente-Bellflower
Bellflower
California
Alta Bates Summit Medical Center-Herrick Campus
Berkeley
California
Mills-Peninsula Medical Center
Burlingame
California
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park
California
Mercy San Juan Medical Center
Carmichael
California
Eden Hospital Medical Center
Castro Valley
California
University Oncology Associates
Clovis
California
John Muir Medical Center-Concord
Concord
California
City of Hope Corona
Corona
California
Sutter Davis Hospital
Davis
California
City of Hope Comprehensive Cancer Center
Duarte
California
Mercy Cancer Center - Elk Grove
Elk Grove
California
Kaiser Permanente-Fontana
Fontana
California
Palo Alto Medical Foundation-Fremont
Fremont
California
Saint Jude Medical Center
Fullerton
California
Kaiser Permanente South Bay
Harbor City
California
Kaiser Permanente-Irvine
Irvine
California
UC San Diego Moores Cancer Center
La Jolla
California
Loma Linda University Medical Center
Loma Linda
California
Kaiser Permanente Los Angeles Medical Center
Los Angeles
California
Los Angeles General Medical Center
Los Angeles
California
+ 844 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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