Suspended

NSCLCNivolumab (Anti-PD1 Antibody) and Ipilimumab (Anti-CTLA4 Antibody) in Combination With Immunogenic Chemotherapy for Patients With Advanced Non-Small Cell Lung Cancer

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What is being tested

Nivolumab

+ Oxaliplatin

+ Ipilimumab

Drug
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: August 2019
See protocol details

Summary

Principal SponsorHatim Husain
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 14, 2019

Actual date on which the first participant was enrolled.

The purpose of this study is to examine the safety and efficacy of combining Nivolumab and low-dose Oxaliplatin with or without Ipilumumab in patients who have had their advanced NSCLC cancer worsen on or after being treated with certain immunotherapies (drugs that target the immune system). Nivolumab (Opdivo®) is approved by the Food and Drug Administration (FDA) for the treatment of metastatic (the cancer has spread) NSCLC. It is a type of drug called a monoclonal antibody (a type of protein). Monoclonal antibodies bind to other proteins, such as PD-1 (programmed cell death-1), on immune cells, which allows the immune cells to continue working against the tumor. Ipilumumab (Yervoy®) is also a monoclonal antibody, but binds to a protein called CTLA-4 (cytotoxic T-lymphocyte-associated protein 4). Oxaliplatin is a type of immunogenic chemotherapy, which may increase the body's immune response to the cancer. Both are approved for treatment of other types of cancers, but not in patients with NSCLC.

Official TitleNivolumab (Anti-PD1 Antibody) and Ipilimumab (Anti-CTLA4 Antibody) in Combination With Immunogenic Chemotherapy for Patients With Advanced Non-Small Cell Lung Cancer
Principal SponsorHatim Husain
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

The following list is a summary. Additional criteria apply. Inclusion Criteria: Patients must meet all of the following criteria to be eligible for study entry. * At least 18 years or older * Histologically or cytologically confirmed, advanced non-squamous or squamous NSCLC * Last line of therapy for advanced non-squamous or squamous NSCLC must be with an anti-PD1 or PDL1 antibody with confirmed progression on or after that treatment. Patients may have received no more than 3 lines of prior therapy including no more than 2 prior lines of therapy containing a PD-(L)-2 antibody. Patients must have received prior cisplatin or carboplatin based doublet chemotherapy. * Measurable disease, as defined by RECIST v1.1 * Adequate hematologic and end-organ function, defined by the laboratory test results within 14 days prior to randomization: * For female patients of childbearing potential and male patients with partners of childbearing potential, agreement to use a highly effective form(s) of contraception during study treatment that results in a low failure rate of \<1% per year when used consistently and correctly. Female patients should continue contraception use for 5 months after the last dose of nivolumab and ipilimumab and for 6 months after the last dose of oxaliplatin. Make patients treated with chemotherapy should continue contraception use for 7 months after the last dose of chemotherapy. Men should refrain from donating sperm during this same period. Such methods include combined (estrogen and progestogen containing) hormonal contraception, with another additional barrier method always containing a spermicide, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion or vasectomized partner (on the understanding that this is the only one partner during the study duration), and sexual abstinence. * Oral contraception should always be combined with an additional contraceptive method because of a potential interaction with the study drug. The same rules are valid for male patients involved in this study if they have a partner of childbearing potential. Male patients must always use a condom. * Women who are not postmenopausal (\>12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study drug. Exclusion Criteria: General Medical Exclusions * Women who are pregnant, lactating, or intending to become pregnant during the study. * History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. * History of autoimmune disease * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. * Major surgical procedure other than for diagnosis within 28 days prior to randomization or anticipation of need for a major surgical procedure during the course of the study. * Prior allogeneic bone marrow transplantation or solid organ transplantation. Exclusion Criteria Related to Medications * Treatment with any approved anti-cancer therapy within 2 weeks prior to initiation of study treatment. * Treatment with any other investigational agent with therapeutic intent within 21 days prior to enrollment. * Received therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to enrollment.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Cohort 1

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

UC San Diego Moores Cancer Center

La Jolla, United StatesOpen UC San Diego Moores Cancer Center in Google Maps
SuspendedOne Study Center