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ACTIVE NOT RECRUITING

NCT02595944

PHASE3

Nivolumab After Surgery and Chemotherapy in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer (An ALCHEMIST Treatment Trial)

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

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.

Official title: Adjuvant Nivolumab in Resected Lung Cancers (ANVIL)-A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

903

Start Date

2016-07-22

Completion Date

2027-05-31

Last Updated

2026-10-01

Healthy Volunteers

Conditions

Stage IB Lung Non-Small Cell Carcinoma AJCC v7 Stage II Lung Non-Small Cell Cancer AJCC v7 Stage IIIA Lung Non-Small Cell Cancer AJCC v7

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Echocardiography Test

Undergo ECHO

BIOLOGICAL

Nivolumab

Given IV

OTHER

Observation Activity

Undergo observation

PROCEDURE

Positron Emission Tomography

Undergo PET-CT

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

Locations (884)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Southern Cancer Center PC-Daphne

Daphne, Alabama, United States

Southern Cancer Center PC-Mobile

Mobile, Alabama, United States

Southern Cancer Center PC-Providence

Mobile, Alabama, United States

Southern Cancer Center PC-Springhill

Mobile, Alabama, United States

Katmai Oncology Group

Anchorage, Alaska, United States

Providence Alaska Medical Center

Anchorage, Alaska, United States

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Banner University Medical Center - Tucson

Tucson, Arizona, United States

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

John L McClellan Memorial Veterans Hospital

Little Rock, Arkansas, United States

Kaiser Permanente-Anaheim

Anaheim, California, United States

PCR Oncology

Arroyo Grande, California, United States

Sutter Auburn Faith Hospital

Auburn, California, United States

Sutter Cancer Centers Radiation Oncology Services-Auburn

Auburn, California, United States

AIS Cancer Center at San Joaquin Community Hospital

Bakersfield, California, United States

Kaiser Permanente-Baldwin Park

Baldwin Park, California, United States

Kaiser Permanente-Bellflower

Bellflower, California, United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Mills-Peninsula Medical Center

Burlingame, California, United States

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, United States

Mercy San Juan Medical Center

Carmichael, California, United States

Eden Hospital Medical Center

Castro Valley, California, United States

University Oncology Associates

Clovis, California, United States

John Muir Medical Center-Concord

Concord, California, United States

City of Hope Corona

Corona, California, United States

Sutter Davis Hospital

Davis, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Mercy Cancer Center - Elk Grove

Elk Grove, California, United States

Kaiser Permanente-Fontana

Fontana, California, United States

Palo Alto Medical Foundation-Fremont

Fremont, California, United States

Saint Jude Medical Center

Fullerton, California, United States

Kaiser Permanente South Bay

Harbor City, California, United States

Kaiser Permanente-Irvine

Irvine, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Loma Linda University Medical Center

Loma Linda, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Kaiser Permanente West Los Angeles

Los Angeles, California, United States

Fremont - Rideout Cancer Center

Marysville, California, United States

Memorial Medical Center

Modesto, California, United States

Palo Alto Medical Foundation-Camino Division

Mountain View, California, United States

Palo Alto Medical Foundation-Gynecologic Oncology

Mountain View, California, United States

Sutter Cancer Research Consortium

Novato, California, United States

Saint Joseph Hospital - Orange

Orange, California, United States

Desert Regional Medical Center

Palm Springs, California, United States

Palo Alto Medical Foundation Health Care

Palo Alto, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Kaiser Permanente - Panorama City

Panorama City, California, United States

Eisenhower Medical Center

Rancho Mirage, California, United States

Mercy Regional Cancer Center

Redding, California, United States

Mercy Oncology Center

Redding, California, United States

Kaiser Permanente-Riverside

Riverside, California, United States

Mercy Cancer Center - Rocklin

Rocklin, California, United States

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, United States

Sutter Roseville Medical Center

Roseville, California, United States

Mercy Cancer Center - Sacramento

Sacramento, California, United States

Sutter Medical Center Sacramento

Sacramento, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Kaiser Permanente-San Diego Zion

San Diego, California, United States

Naval Medical Center -San Diego

San Diego, California, United States

California Pacific Medical Center-Pacific Campus

San Francisco, California, United States

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, United States

Kaiser Permanente-San Marcos

San Marcos, California, United States

Dominican Santa Cruz Hospital

Santa Cruz, California, United States

Palo Alto Medical Foundation-Santa Cruz

Santa Cruz, California, United States

Sutter Pacific Medical Foundation

Santa Rosa, California, United States

Saint Helena Hospital

St. Helena, California, United States

Saint Joseph's Medical Center

Stockton, California, United States

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, United States

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, United States

Sutter Solano Medical Center/Cancer Center

Vallejo, California, United States

John Muir Medical Center-Walnut Creek

Walnut Creek, California, United States

Woodland Memorial Hospital

Woodland, California, United States

Kaiser Permanente-Woodland Hills

Woodland Hills, California, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Kaiser Permanente-Franklin

Denver, Colorado, United States

AdventHealth Porter

Denver, Colorado, United States

Mountain Blue Cancer Care Center - Swedish

Englewood, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

National Jewish Health-Western Hematology Oncology

Golden, Colorado, United States

Banner North Colorado Medical Center

Greeley, Colorado, United States

Kaiser Permanente-Rock Creek

Lafayette, Colorado, United States

Rocky Mountain Cancer Centers-Lakewood

Lakewood, Colorado, United States

Kaiser Permanente-Lone Tree

Lone Tree, Colorado, United States

Banner North Colorado Medical Center - Loveland Campus

Loveland, Colorado, United States

AdventHealth Parker

Parker, Colorado, United States

Intermountain Health Lutheran Hospital

Wheat Ridge, Colorado, United States

Danbury Hospital

Danbury, Connecticut, United States

Smilow Cancer Hospital-Derby Care Center

Derby, Connecticut, United States

Smilow Cancer Hospital Care Center-Fairfield

Fairfield, Connecticut, United States

Greenwich Hospital

Greenwich, Connecticut, United States

Smilow Cancer Hospital Care Center - Guilford

Guilford, Connecticut, United States

Hartford Hospital

Hartford, Connecticut, United States

And 784 more locations on ClinicalTrials.gov

Clinical Research Directory

Nivolumab After Surgery and Chemotherapy in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer (An ALCHEMIST Treatment Trial)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (884)