CLINICAL TRIAL

Nivolumab for Adenocarcinoma

Metastatic
Stage III
Recruiting · 18+ · All Sexes · Newark, DE

Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Stage IV Non-Small Cell Lung Cancer Patients Who Are PD-L1 Negative

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About the trial for Adenocarcinoma

Eligible Conditions
Adenocarcinoma · Adenocarcinoma of Lung · Metastatic Lung Non-Small Cell Carcinoma · Advanced Lung Adenocarcinoma · Carcinoma · Advanced Lung Adenosquamous Carcinoma · Stage IV Lung Cancer AJCC v8 · Carcinoma, Non-Small-Cell Lung · Metastatic Lung Adenosquamous Carcinoma · Carcinoma, Adenosquamous · Lung Neoplasms · Metastatic Lung Adenocarcinoma · Stage IVB Lung Cancer AJCC v8 · Advanced Non-Small Cell Lung Carcinoma · Stage IIIC Lung Cancer AJCC v8 · Stage IIIB Lung Cancer AJCC v8 · Stage IVA Lung Cancer AJCC v8

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 2 & 3 and have had some early promising results.

Experimental Group 1
Nivolumab
BIOLOGICAL
+
Paclitaxel
DRUG
+
Nab-paclitaxel
DRUG
+
Carboplatin
DRUG
+
Ipilimumab
BIOLOGICAL
+
Pembrolizumab
BIOLOGICAL
+
Pemetrexed
DRUG
+
Quality-of-Life Assessment
OTHER
Experimental Group 2
Nivolumab
BIOLOGICAL
+
Paclitaxel
DRUG
+
Nab-paclitaxel
DRUG
+
Carboplatin
DRUG
+
Ipilimumab
BIOLOGICAL
+
Pembrolizumab
BIOLOGICAL
+
Pemetrexed
DRUG
+
Quality-of-Life Assessment
OTHER
+
Stereotactic Body Radiation Therapy
RADIATION

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Paclitaxel
FDA approved
Albumin human
FDA approved
Carboplatin
FDA approved
Ipilimumab
FDA approved
Pembrolizumab
FDA approved
Pemetrexed
FDA approved
Stereotactic Body Radiation Therapy
2016
Completed Phase 2
~560

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
PD-L1 expression tumor proportion score (TPS) < 1% in tumor cells. If PD-L1 expression TPS is unevaluable or the testing could not be completed patients are not eligible. The assay must have been performed locally by a Clinical Laboratory Improvement Act (CLIA) (or equivalent) certified laboratory. The type of assay will be recorded
Chemotherapy for non-metastatic disease (e.g., adjuvant therapy) or immunotherapy for locally advanced stage III disease is allowed if terminated at least 6 months prior to registration
No systemic immunostimulatory or immunosuppressive drugs, including > 10 mg prednisone equivalent per day, within 2 weeks or 5 half-live of the drug, whichever is shorter
Histologic or cytologic diagnosis of stage IV NSCLC using version American Joint Committee on Cancer (AJCC) 8th edition (includes M1a, M1b, and M1c stage disease). Patients with Stage IIIB and IIIC disease are eligible if they are not a candidate for combined chemotherapy and radiation
For non-squamous patients only (adenocarcinoma or adenosquamous): EGFR, ALK and ROS1 testing must be done locally. No patients with known actionable EGFR mutations (except exon 20 insertion), ALK or ROS1 mutations that can be treated with oral tyrosine inhibitors
Measurable disease based on RECIST 1.1, including at least two cancerous deposits. At least one deposit must be RECIST measurable (and not to be irradiated) while at least one OTHER deposit (measurable or non-measurable) must meet criteria for stereotactic body radiation therapy (SBRT)
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
No prior systemic chemotherapy or immunotherapy for advanced NSCLC
No prior treatment with checkpoint inhibitors for metastatic lung cancer
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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 5 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 5 years.
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 2 primary outcomes and 4 secondary outcomes in patients with Adenocarcinoma. Measurement will happen over the course of From randomization to disease progression or death of all causes, whichever comes first, assessed up to 5 years.

PFS
FROM RANDOMIZATION TO DISEASE PROGRESSION OR DEATH OF ALL CAUSES, WHICHEVER COMES FIRST, ASSESSED UP TO 5 YEARS
Assessed per Response Evaluation Criteria in Solid Tumors (RECIST).
FROM RANDOMIZATION TO DISEASE PROGRESSION OR DEATH OF ALL CAUSES, WHICHEVER COMES FIRST, ASSESSED UP TO 5 YEARS
Progression-free survival (PFS) (Phase II)
FROM RANDOMIZATION TO DISEASE PROGRESSION OR DEATH OF ALL CAUSES, WHICHEVER COMES FIRST, ASSESSED UP TO 5 YEARS
Will be performed on an ITT basis.
FROM RANDOMIZATION TO DISEASE PROGRESSION OR DEATH OF ALL CAUSES, WHICHEVER COMES FIRST, ASSESSED UP TO 5 YEARS
Overall survival (OS) (Phase III)
FROM RANDOMIZATION AND DEATH OF ALL CAUSES, ASSESSED UP TO 5 YEARS
Will be performed on an intent-to-treat (ITT) basis. The comparison of the distributions of OS between treatment arms will be done with a one-sided stratified log-rank test). The rates at various time points (e.g., every 6 months after randomization) and medians of OS for each arm will be estimated using the Kaplan-Meier estimator. The associated 95% confidence interval (CI) will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Hazard ratios will be estimated using a stratified Cox regression model. The final phase III analysis of OS will be considered as "positive" if the stratified log-rank test statistics Z-value greater than the critical value adjusted for type 1 error using group sequential methods. Multivariable Cox models will be used to evaluate the treatment effect on survival time and its interaction with baseline covariates, including stage, systemic therapy, histology and performance status.
FROM RANDOMIZATION AND DEATH OF ALL CAUSES, ASSESSED UP TO 5 YEARS
Quality of life
UP TO 5 YEARS
UP TO 5 YEARS
Incidence of treatment-related adverse events
UP TO 5 YEARS
Treatment-related toxicity will be summarized by grade, type, and system organ class. Comparisons of the percentages of patients experiencing an adverse event between Arm A and Arm B will be performed using Fisher's exact test.
UP TO 5 YEARS
Objective response rate (ORR)
UP TO 5 YEARS
Assessed per RECIST for both irradiated and un-irradiated areas. The ORRs between treatments will be compared with Fisher's exact test. The difference of ORR between treatments will be estimated by the Miettinen-Nurminen method and its 95%CI will be given. Multivariable logistic regression will be used to evaluate the treatment effect on ORR while adjusting for significant baseline covariates.
UP TO 5 YEARS

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 is the survival rate for carcinoma?

The 5-year survival rate for carcinoma was 57%. In this group of patients, the most common sites of cancer were the larynx (20%), lungs (18%), breast (11%) and colon (8%). Survival was better with smaller cancers (<3 cm), with stage II cancers, and with organ-confined disease.

Anonymous Patient Answer

How quickly does carcinoma spread?

The risk of transmission between people must outweigh any benefit of screening. The risk of transmission could be reduced through earlier diagnosis, facilitated detection by screening, improved treatment, and education.

Anonymous Patient Answer

What does nivolumab usually treat?

The majority of tumors treated with nivolumab were [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer)s. Clinical trial results from 2011 suggest that patients with NSCLC may benefit from this drug. More data are needed to determine whether all cancer types respond to nivolumab.

Anonymous Patient Answer

Does carcinoma run in families?

Since we found no evidence of an excess of cancers among siblings, we conclude that there is no strong evidence that familial cancers are caused by mutations in inherited oncogenes.

Anonymous Patient Answer

Can carcinoma be cured?

Data from a recent study of this study demonstrated that all forms of carcinoma were associated with high mortality rates for both genders. Prognosis was worse for patients administered chemotherapy. The present data suggest that appropriate patient selection based on prognostic factors may improve patient survival.

Anonymous Patient Answer

How serious can carcinoma be?

Carcinoma is extremely dangerous and can cause death very quickly. If you have questions as to how serious carcinoma is, see the "Treatment" section below.

Anonymous Patient Answer

What are the latest developments in nivolumab for therapeutic use?

Nivolumab is an immunotherapy that inhibits PD-1, a vital immune checkpoint molecule that prevents the immune system from attacking the tumor. Drugs such as ipilimumab were developed to target T cells, which ordinarily attack cancerous cells. However, T cell function is inhibited when PD-1 is expressed by cancer cells. By targeting PD-1, nivolumab enables the patient's own T cells to destroy cancers. Clinical trials have shown that patients treated with nivolumab experience less severe side effects than those receiving other treatments.

Anonymous Patient Answer

What is the latest research for carcinoma?

The development and dissemination of information on cancer screening is an ongoing process. There has been increased interest in prostate-specific antigen testing for prostate cancer detection because it is a noninvasive procedure and does not require access to medical imaging, unlike computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), and ultrasound scanning. A meta-analysis concluded that PSA testing increases detection of prostate cancer, but this benefit is only present when performing more than one test per year. Also, PSA levels rise and fall faster during testosterone replacement therapy and have a shorter shelf life than other measurements of serum testosterone. Therefore, more studies need to be conducted in order to better understand these issues.

Anonymous Patient Answer

Who should consider clinical trials for carcinoma?

Results from a recent clinical trial of this study indicate that younger patients with early stage carcinoma are more likely to be eligible for clinical trials. In addition, the presence of comorbid conditions does not preclude the participation of older patients with advanced carcinomas.

Anonymous Patient Answer

How many people get carcinoma a year in the United States?

The incidence of cancer was lower than previously reported in the US population. Recent findings highlight the need for more accurate reporting of the incidence of cancer by age, sex, race or ethnicity, and tumour type.

Anonymous Patient Answer

Is nivolumab safe for people?

Nivolumab was well tolerated in patients with metastatic NSCLC. It did not appear to cause significant immunosuppression compared with placebo, though more frequent infusion reactions were seen. Additional studies are warranted to better understand how nivolumab affects immune system function, its potential synergistic effects with other therapies, and its efficacy and safety in people with lung cancer.

Anonymous Patient Answer
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