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Clinical Trials in Mexico / NCT02595944
Active, not recruiting Phase 3

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

NCT02595944 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 3
Started
2016-07-22
Last updated
2026-10-01

Condition(s) studied

Stage IB Lung Non-Small Cell Carcinoma AJCC v7Stage II Lung Non-Small Cell Cancer AJCC v7Stage IIIA Lung Non-Small Cell Cancer AJCC v7

Investigational drug(s) / intervention(s)

Biospecimen CollectionComputed TomographyEchocardiography TestNivolumab →Observation ActivityPositron Emission Tomography

Biospecimen Collection: Undergo blood sample collection

Computed Tomography: Undergo CT

Echocardiography Test: Undergo ECHO

Nivolumab: Given IV

Observation Activity: Undergo observation

Positron Emission Tomography: Undergo PET-CT

Study 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.

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)

Trial sites (884)

FacilityCityRegionStatus
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.

On this site

📄 Opdivo (nivolumab) drug profile →

More National Cancer Institute (NCI) trials in Mexico

Other trials for the same condition

Official registry record

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.

View NCT02595944 on ClinicalTrials.gov ↗ ← All trials in Mexico