CLINICAL TRIAL

Nivolumab for Carcinoma, Non-Small-Cell Lung

Waitlist Available · 18+ · All Sexes · Xian, China

This study is evaluating whether a new drug called nivolumab can help treat lung cancer.

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About the trial for Carcinoma, Non-Small-Cell Lung

Eligible Conditions
Carcinoma, Non-Small-Cell Lung · Non-Small Cell Lung Carcinoma (NSCLC)

Treatment Groups

This trial involves 3 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 3 and have had some early promising results.

Experimental Group 1
Nivolumab
BIOLOGICAL
+
Pemetrexed
DRUG
+
Cisplatin
DRUG
+
Carboplatin
DRUG
Experimental Group 2
Ipilimumab
BIOLOGICAL
+
Nivolumab
BIOLOGICAL
Control Group 3
Pemetrexed
DRUG
+
Cisplatin
DRUG
+
Carboplatin
DRUG

About The Treatment

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

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Carcinoma, Non-Small-Cell Lung or the other condition listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You have been treated with an EGFR TKI for at least 2 months prior to your diagnosis. show original
No evidence of exon 20 T790M mutation obtained at progression on prior first- or second-generation EGFR TKI therapy.
Measurable disease according to RECIST 1.1. show original
Available tumor sample for Programmed death-ligand 1 (PD-L1) immunohistochemical (IHC). For participants who were treated with osimertinib, T790M testing is not required.
You are eligible if you have a central nervous system (CNS) metastasis and are on a stable or decreasing dose of prednisone (or equivalent) for at least 2 weeks prior to randomization show original
Eastern Cooperative Group (ECOG) Performance Status 0-1
Life expectancy is at least 3 months
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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: Up to 74 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 74 months.
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 4 secondary outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of Up to 47 months.

Progression free survival (PFS) rate by BICR
UP TO 47 MONTHS
Progression free survival (PFS) assessed by blinded independent central review (BICR)
UP TO 47 MONTHS
Duration of response (DOR) by BICR
UP TO 47 MONTHS
Objective response rate (ORR) per response evaluation criteria in solid tumors (RECIST) 1.1 by BICR
UP TO 47 MONTHS
Overall survival (OS)
UP TO 74 MONTHS

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 carcinoma, non-small-cell lung?

Given the increasing incidence of lung cancer, with a declining average age of diagnosis, this article provides an overview of the available clinical literature and the signs of carcinoma, non-small-cell lung. This overview is intended to help in the identification of new lung cancers and in the early exclusion of more benign lung lesions.

Anonymous Patient Answer

How many people get carcinoma, non-small-cell lung a year in the United States?

around 683,000 people will have carcinoma, non-small-cell lung each year in the Unites States. Overall, a quarter of cancers in women with an underlying lung disease are due to this type of cancer.

Anonymous Patient Answer

Can carcinoma, non-small-cell lung be cured?

The current results show a lack of effective treatment strategies for NSCLC. The lack of cure, combined with the long duration of most NSCLC clinical trials (range of 10-40 weeks) and the limited number of patients included, make current results difficult to apply to a clinical perspective or to patients with NSCLC. Further, and larger, multicenter trials need to be carried out.

Anonymous Patient Answer

What is carcinoma, non-small-cell lung?

Cancer, non-small-cell lung is the second most common invasive cancer, responsible for roughly 7.8% of all cancer cases annually in the U.S and is the second leading cause of cancer death (after breast cancer) and, along with lung cancer, is the largest contributor to cancer-related mortality in the U.S. Cancer, non-small-cell lung can cause a wide spectrum of signs and symptoms, including shortness of breath, pain, and weight loss. People with cancer, non-small cell lung can have an impaired quality of life due to their disease, which leads to a decrease in their overall health and a decreased ability to care for themselves and their family.

Anonymous Patient Answer

What are common treatments for carcinoma, non-small-cell lung?

The 5-year overall survival for patients with metastatic carcinoma, non-small-cell lung is about 17%; and the survival from metastatic carcinoma, non-small-cell lung is about 14%. Very common treatments for metastatic carcinoma, non-small-cell lung include surgery, radiotherapy, and chemotherapy.

Anonymous Patient Answer

What causes carcinoma, non-small-cell lung?

The causes of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) can be broken down into hereditary factors, environmental and lifestyle factors, and, lastly, cancer-related factors. It is important to acknowledge that the causes of lung cancer include many genetic and environmental factors that are not clearly identified.

Anonymous Patient Answer

How serious can carcinoma, non-small-cell lung be?

Lung carcinoma is the second most common cancer in the US and is responsible for 11 percent of cancer deaths, with an additional 11 percent in the 20-to-40-year-old age group. Most patients survive after two years and almost to their death: the probability of survival is approximately 0.3% per year. However, the chances of survival in the first year of diagnosis are over 90%. The overall five-year survival rate of lung cancer is about 43 to 70%, with the most common causes of disease mortality being pleural effusion, bone cancer, consolidation, and infection (mostly due to bacterial pneumonia or tuberculosis).

Anonymous Patient Answer

Has nivolumab proven to be more effective than a placebo?

In the first 12 weeks in the RECIST 1.1 phase I/II trial, treatment with NIV-V10 was generally well tolerated with few infusion- and dose-limiting events. More durable response rates will be needed to define the clinical significance of this study.

Anonymous Patient Answer

What does nivolumab usually treat?

Nivolumab often inhibits [cancer cells with mutated EGFR gene (which has been proven to be a marker of aggressive cancers)] but can also restrain tumour growth in some of the less aggressive cancers. A single cycle of nivolumab typically leads to tumour regression in certain cancers; its use at a higher dose and at a later time points is, however, warranted to achieve durable responses, which will be most likely to affect the overall survival.

Anonymous Patient Answer

What are the chances of developing carcinoma, non-small-cell lung?

According to the SEER database, a 6-fold higher overall risk (OR =6.0) and a 7-fold increased risk (OR =7.2) of developing carcinoma, non-small cell lung, exists among those with previous cases of these types of cancers. In the following table, a greater risk of developing lung cancer is indicated by a greater OR.

Anonymous Patient Answer

What are the common side effects of nivolumab?

In patients treated with nivolumab, common adverse events included fatigue (63.4% of patients) and gastrointestinal events (31.0% of patients), more so than in patients treated with systemic therapy alone (29.5% vs 28%). There were no clinical differences in side effects between nivolumab-treated patients and those receiving systemic therapy with chemotherapy and/or radiation therapy. Although fatigue was frequent, more than half of nivolumab-treated patients reported an improvement in fatigue compared with systemic therapy alone. Further studies are necessary to better understand this adverse effect and develop patient treatment strategies.

Anonymous Patient Answer

What is the average age someone gets carcinoma, non-small-cell lung?

Nearly half (49.0) of lung cancers reported in the United States are diagnosed in people aged 65 or older. The survival rate for lung cancer is lower for this population. In an era of universal healthcare coverage, advances in prevention and early detection may improve survival rates for seniors with lung cancer.

Anonymous Patient Answer
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