CLINICAL TRIAL

Cisplatin for Lung Cancer

1 Prior Treatment
Metastatic
Recurrent
Stage III
Recruiting · 18+ · All Sexes · Seattle, WA

This study is evaluating whether adding a drug to standard treatment may improve outcomes for patients with stage III non-small cell lung cancer.

See full description

About the trial for Lung Cancer

Eligible Conditions
Stage IIIA Lung Cancer AJCC v8 · Locally Advanced Lung Non-Small Cell Carcinoma · Stage IIIB Lung Cancer AJCC v8 · Stage III Lung Cancer AJCC v8 · Stage IIIC Lung Cancer AJCC v8 · Carcinoma, Non-Small-Cell Lung · Lung Neoplasms

Treatment Groups

This trial involves 2 different treatments. Cisplatin is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Cisplatin
DRUG
Durvalumab
BIOLOGICAL
Etoposide
DRUG
Pemetrexed
DRUG
Hypofractionated Radiation Therapy
RADIATION
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Platinum
Not yet FDA approved
Durvalumab
FDA approved
Etoposide
FDA approved
Pemetrexed
FDA approved
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~20

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Lung Cancer or one of the other 6 conditions listed above. 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:
This trial will allow a maximum of 20 patients who have bulky mediastinal disease, which is defined as at least one contiguous mediastinal mass with a minimum diameter of 2 cm that is not contiguous with the primary tumor show original
The life expectancy of a rat is >= three months. show original
Stage III NSCLC is divided into three substages: IIIA, IIIB, and IIIC show original
At least one tumor that is located in the mediastinum and is not adjacent to any other tumors. show original
The National Lung Cancer Partnership (NLCP) is urging people with lung cancer to wait at least three years before considering surgery show original
The person must not have any other types of cancer for at least 3 years, except for cancers that are considered to be low grade or non-invasive, such as skin cancers, prostate cancers, and ductal breast carcinoma in situ (DCIS). show original
The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 means that the person is fully active and has no limitations in their activities. show original
is excellent Hemoglobin levels of 9.0 g/dL or greater are excellent. show original
diagnosed at any stage A person with non-small cell lung cancer that has been documented by a tissue sample is said to have NSCLC show original
Body weight > 30 kg
View All
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

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: From study registration to death due to any cause, assessed up to 12 months after treatment
Screening: ~3 weeks
Treatment: Varies
Reporting: From study registration to death due to any cause, assessed up to 12 months after treatment
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From study registration to death due to any cause, assessed up to 12 months after treatment.
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 Cisplatin will improve 1 primary outcome and 4 secondary outcomes in patients with Lung Cancer. Measurement will happen over the course of From study registration to death due to any cause, assessed up to 12 months after treatment.

Overall survival (OS)
FROM STUDY REGISTRATION TO DEATH DUE TO ANY CAUSE, ASSESSED UP TO 12 MONTHS AFTER TREATMENT
Will be evaluated using the method of Kaplan-Meier. Confidence intervals for median times will be determined using the Brookmeyer-Crowley method. Confidence intervals around landmark times will be determined using Greenwood's formula for the variance and based on a log-log transformation applied on the survival function. Binary proportions will be calculated with associated confidence intervals for binary outcomes, such as response. Means and/or medians will be calculated for continuous outcomes. Confidence bounds will be provided for means and quartiles and ranges for median values. All confidence bounds will be presented as 95% bounds.
FROM STUDY REGISTRATION TO DEATH DUE TO ANY CAUSE, ASSESSED UP TO 12 MONTHS AFTER TREATMENT
Frequency and severity of pneumonitis
UP TO 12 MONTHS AFTER TREATMENT
The primary toxicity of interest is grade 3 or higher pneumonitis. The incidence of grade 3 or worse pneumonitis attributable to treatment will be evaluated and compared against the PACIFIC trial results. All toxicities of all grades will be monitored on study and reported. Binary proportions will be calculated with associated confidence intervals for binary outcomes, such as toxicity.
UP TO 12 MONTHS AFTER TREATMENT
Response rate
UP TO 12 MONTHS AFTER TREATMENT
Will be evaluated using the method of Kaplan-Meier. Confidence intervals for median times will be determined using the Brookmeyer-Crowley method. Confidence intervals around landmark times will be determined using Greenwood's formula for the variance and based on a log-log transformation applied on the survival function. Binary proportions will be calculated with associated confidence intervals for binary outcomes, such as response. Means and/or medians will be calculated for continuous outcomes. Confidence bounds will be provided for means and quartiles and ranges for median values. All confidence bounds will be presented as 95% bounds.
UP TO 12 MONTHS AFTER TREATMENT
Progression-free survival rate (PFS)
FROM STUDY REGISTRATION TO PROGRESSION PER RESPONSE EVALUATION CRITERIA IN SOLID TUMORS (RECIST) 1.1, SYMPTOMATIC DETERIORATION, OR DEATH DUE TO ANY CAUSE, WHICHEVER COMES FIRST, ASSESSED AT 1 YEAR AFTER TREATMENT
Will be evaluated using the method of Kaplan-Meier. Confidence intervals for median times will be determined using the Brookmeyer-Crowley method. Confidence intervals around landmark times will be determined using Greenwood's formula for the variance and based on a log-log transformation applied on the survival function. Binary proportions will be calculated with associated confidence intervals for binary outcomes, such as response. Means and/or medians will be calculated for continuous outcomes. Confidence bounds will be provided for means and quartiles and ranges for median values. All confidence bounds will be presented as 95% bounds.
FROM STUDY REGISTRATION TO PROGRESSION PER RESPONSE EVALUATION CRITERIA IN SOLID TUMORS (RECIST) 1.1, SYMPTOMATIC DETERIORATION, OR DEATH DUE TO ANY CAUSE, WHICHEVER COMES FIRST, ASSESSED AT 1 YEAR AFTER TREATMENT
Incidence of adverse events
UP TO 12 MONTHS AFTER TREATMENT
Frequency and severity of toxicities will be graded with Common Terminology Criteria for Adverse Events (CTCAE), version 5. Toxicities will be summarized as the proportion of patients with such toxicities, in addition to total number of toxicities (allowing for multiple toxicities within a patient) among all patients. All toxicities of all grades will be monitored on study and reported. Binary proportions will be calculated with associated confidence intervals for binary outcomes, such as toxicity.
UP TO 12 MONTHS AFTER TREATMENT

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 causes lung cancer?

Among cases identified by telephone survey, no significant increase in the incidence of lung cancer was reported during the three surveys. Despite recent reviews of the available data, no specific trends or epidemiologic relationships among risk factors or factors thought to be risk factors for either lung cancer development or mortality have been identified. However, some associations between lung cancer and other factors have been reported, and some have been shown to increase the risk of lung cancer. Thus, even if no clear picture emerges from all of the available data, the association of some risk factors with lung cancer is strong enough to justify a careful inquiry into the associations between those risk factors and lung cancer risk.

Anonymous Patient Answer

What are the signs of lung cancer?

It is difficult to distinguish between COPD and lung cancer based solely on clinical characteristics, but clinical features such as a history of cigarette smoking, cough and shortness of breath on rising should prompt consideration of lung cancer.

Anonymous Patient Answer

How many people get lung cancer a year in the United States?

Approximately 56,000 newly diagnosed lung cancers will be diagnosed in 2020. This is an average of 5.1 diagnoses per 100,000 population. This translates to an annual incidence of around 35 new lung cancer diagnoses per 100,000 persons (average of 5.1 diagnoses per 100,000 persons).

Anonymous Patient Answer

Can lung cancer be cured?

The only option for cure of lung cancer is the surgical removal with lymph node dissection of the primary tumor. Although radiotherapy, particularly in those with large tumors, provides a survival rate comparable to that found for resection, local control is incomplete, and this may be due to the high rate of local failures. Surgical resection is justified only as an adjunct to radiotherapy in the hope that the local control achieved by surgery will result in improved overall survival.

Anonymous Patient Answer

What are common treatments for lung cancer?

There are more people diagnosed with lung cancer during their 50s than in any other age group. Over the past decade, the prevalence of lung cancer has decreased in men after a large increase from the early 1980s, whereas it has increased in women. The most common forms of treatment include surgery, chemotherapy, hormonal, targeted, and/or targeted and hormonal therapy. Treatments are often provided in a multimodality treatment approach, using both surgery, chemotherapy, and/or targeted chemotherapy. In the United States, the most common form of the disease is non-small cell lung cancer, occurring in 20% of cases.

Anonymous Patient Answer

What is lung cancer?

The word [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) is not a very well-known name which is associated with the lung tissue but it is a cancer of lung tissue.

Anonymous Patient Answer

Has cisplatin proven to be more effective than a placebo?

The addition of cisplatin to a standard regimen of carboplatin + etoposide did not improve the control of disease, as assessed by tumour volume, or survival in this small study.

Anonymous Patient Answer

Is cisplatin typically used in combination with any other treatments?

Although cisplatin is often used in combination with other medications, the addition of gemcitabine and cisplatin are not very effective by themselves. The addition of either cisplatin or gemcitabine did not significantly improve the effectiveness of cisplatin alone to treat first or second line patients with stage III non-small cell bronchial carcinoma.

Anonymous Patient Answer

How does cisplatin work?

The use of cisplatin is highly effective as salvage chemotherapy in patients with squamous cell cancer. The response rate is 20%. In this population of patients, the use of cisplatin reduces the number of subsequent hospitalizations by 50%, as well as suppressing the number of subsequent metastases.

Anonymous Patient Answer

Is cisplatin safe for people?

The current data suggested that cisplatin was well tolerated and did not increase the risk of haematological toxicity or other adverse reactions associated with its use in patients with advanced NSCLC. Patients who required intensive care for their primary malignancy during chemotherapy were at a heightened risk of haematological disease.

Anonymous Patient Answer

What does cisplatin usually treat?

Cisplatin (the standard chemotherapeutic agent for [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer)) is most efficacious in lung cancers that have not infiltrated the peripheral region of the lung, as well. In those cases, the drug can be given as adjuvant therapy after a complete resection of the tumor has been accomplished. However, if the tumor has locally invaded the pleural cavity, then the addition of cisplatin, along with surgery, is not effective and does no good. When an infiltrating cancer is found in the pleural cavity, treatment with a combination of chemotherapy is not efficacious. Chemotherapy treatment should be avoided because its use implies the removal of a small amount of tissue in order to administer it.

Anonymous Patient Answer

What is the primary cause of lung cancer?

The primary cause of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) appears to be tobacco-associated carcinogenesis, whereas asbestos, environmental tobacco smoke and some occupational dusts may also contribute to lung cancer. Lung cancer is one of the leading causes of cancer-related death and disability in Canada. For some lung cancers, lung cancer seems be not to be the primary cause of death or disability, but secondary causes such as lung cancer-associated cardiovascular disease, non-cancer lung disease, other cancers, and second malignancies. Further epidemiologic and molecular studies are warranted to explore the true etiology of lung cancer.

Anonymous Patient Answer
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