CLINICAL TRIAL

Nivolumab for Advanced Non Small Cell Lung Cancer (NSCLC)

Locally Advanced
Metastatic
Recruiting · 18+ · All Sexes · La Jolla, CA

Nivolumab and Ipilimumab in Combination With Immunogenic Chemotherapy for Patients With Advanced NSCLC

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About the trial for Advanced Non Small Cell Lung Cancer (NSCLC)

Treatment Groups

This trial involves 2 different treatments. Nivolumab is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Experimental Group 1
Nivolumab
DRUG
+
Oxaliplatin
DRUG
Experimental Group 2
Ipilimumab
DRUG
+
Nivolumab
DRUG
+
Oxaliplatin
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Nivolumab
FDA approved
Oxaliplatin
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The following list is a summary of the six factors the court will consider when deciding whether to issue a summary judgment show original
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.
Women who are not postmenopausal, surgically sterilized, or taking hormone therapy must have a negative serum pregnancy test result within 14 days prior to initiation of study drug. show original
Patients must meet all of the following criteria in order to be eligible for study entry: be at least 18 years of age, have a confirmed diagnosis of type 2 diabetes, have a body mass index (BMI) of at least 30 kg/m2, and have failed to achieve glycemic control with metformin monotherapy. show original
You must be at least 18 years old to purchase items from our store. show original
The final line of therapy for patients with advanced non-squamous or squamous NSCLC must be an anti-PD1 or PDL1 antibody, with confirmed progression on or after that treatment show original
, is a disease that can be measured by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines show original
in individuals with a good performance status (PS) as per NCI-CTCAE Version 4.0 Enrolled on study, histologically or cytologically confirmed, stage IIIB or IV non-squamous or squamous NSCLC, with a PS of 0 or 1. show original
Patients who take the study drug should always use an additional contraceptive method, since the drug may interact with contraception show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1 and 2 year
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 and 2 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1 and 2 year.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Nivolumab will improve 1 primary outcome and 2 secondary outcomes in patients with Advanced Non Small Cell Lung Cancer (NSCLC). Measurement will happen over the course of 4 months.

Objective response rate (ORR)
4 MONTHS
To estimate ORR by RECIST 1.1
4 MONTHS
Progression-free survival (PFS)
1 YEAR
1 YEAR
Overall survival (OS)
1 AND 2 YEAR
1 AND 2 YEAR

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of advanced non small cell lung cancer (nsclc)?

Advanced NSCLC can present with symptoms of lung cancer due to metastasis. These symptoms are cough, dyspnea, hemoptysis and weight loss. Patients with advanced malignant pleural effusion may present with pleural effusion only. Patients are often asymptomatic and only seen in the context of a CT study for metastatic disease.

Anonymous Patient Answer

What causes advanced non small cell lung cancer (nsclc)?

A number of environmental factors have been related with the development of advanced NSCLC. For instance, exposure to asbestos, chemical fumes of the industrial environment and cigarette smoking increase the risk of developing advanced NSCLC.

Anonymous Patient Answer

How many people get advanced non small cell lung cancer (nsclc) a year in the United States?

247,000 people per year are diagnosed with advanced [non small cell lung cancer](https://www.withpower.com/clinical-trials/non-small-cell-lung-cancer) (nsclc) in the United States, which makes it the most common cancer in American women.

Anonymous Patient Answer

What are common treatments for advanced non small cell lung cancer (nsclc)?

Inclusion in current trials is required for treatment advancement. Most of these studies lack a control arm and have low response rates. Current treatments for patients with advanced NSCLC may have less than a 30% response rate and are associated with significant morbidity. Overall, there is little meaningful evidence for any treatment that can reliably improve clinical outcomes in lung cancer with metastases. A new approach that uses systemic therapy to eradicate micrometastases is the best treatment option in patients with advanced NSCLC.

Anonymous Patient Answer

Can advanced non small cell lung cancer (nsclc) be cured?

Results from a recent clinical trial shows that advanced tumours are not always incurable, especially when they have metastasized. For NSCLC in particular, a cure for all patients is possible by using adjuvant therapies. The role of molecular profiling to select patients for adjuvant therapy and the role of neoadjuvant therapy for patients with good pathological response remain open questions that need to be answered in randomised studies.

Anonymous Patient Answer

What is advanced non small cell lung cancer (nsclc)?

[non small cell [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer)](https://www.withpower.com/clinical-trials/non-small-cell-lung-cancer) is a fatal and highly chemo-resistant cancer that usually develops in never or current smokers. However it is very frequently detected due to non-specific clinical symptoms. Survival in individuals with lung cancer remains poor compared to individuals in general population of the same age. Mortality is mainly depending on stage, comorbidities, smoking status and treatment with chemotherapy agents. The aim of this article is to summarize the pathophysiology, clinical features and treatment options of NSCLC.

Anonymous Patient Answer

Is nivolumab typically used in combination with any other treatments?

Nivolumab is frequently used in combination with other treatments in NSCLC. These combinations offer a substantial number of potential combinations with potential improved disease control in NSCLC, which are typically not explored in this context of the clinical setting.

Anonymous Patient Answer

Have there been any new discoveries for treating advanced non small cell lung cancer (nsclc)?

There are no recent changes in treatment for advanced NSCLC. The discovery of the epidermal growth factor receptor (EGFR) as a target for treatments for advanced NSCLC may lead to improvements in survival for patients with advanced NSCLC.

Anonymous Patient Answer

What are the common side effects of nivolumab?

The most commonly reported Side Effects of nivolumab treatment were Skin reactions, fatigue, itchiness, dizziness, decreased appetite, pain and sore throat. No significant changes in any of the haematology parameters investigated in this study. Although no clinically significant changes in blood pressure or cardiac function occurred during the course of nivolumab monotherapy treatment in the studied population, patients should continue to closely monitor these parameters.

Anonymous Patient Answer

Does nivolumab improve quality of life for those with advanced non small cell lung cancer (nsclc)?

Nivolumab in combination with platinum based neoadjuvant chemotherapy and concurrent chemoradiotherapy in stage III-IV NSCLC is tolerable and improves HRQoL when compared with chemotherapy alone.

Anonymous Patient Answer

How does nivolumab work?

Nivolumab is an effective treatment for advanced NSCLC, as demonstrated by the results of this clinical trial. Although more than 50% of patients have objective responses to nivolumab, almost all patients experience some increase in tumor size. These patients have a high rate of progressive disease at the time of nivolumab discontinuation (mean cumulative incidence of progressive disease = 41%). Patients should expect that nivolumab will delay the disease progression before their disease progresses. Physicians should be aware of this risk if patients are contemplating treatment with this therapeutic.

Anonymous Patient Answer

What is the primary cause of advanced non small cell lung cancer (nsclc)?

[Tobacco is a significant risk for most of the advanced non small cell lung cancers (nsclc). Tobacco use is the major cause of advanced non small cell lung cancers (nsclc) globally, we therefore need to take tobacco use as a significant risk factor of advanced non small cell lung cancer (nsclc). (J. J. Tissier's research, 2016)]

Anonymous Patient Answer
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