CLINICAL TRIAL

Ramucirumab for Carcinoma, Non-Small-Cell Lung

Metastatic
Waitlist Available · 18+ · All Sexes · Heidelberg, Germany

This study is evaluating whether a drug called ramucirumab can improve the survival of people with lung cancer.

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

Eligible Conditions
Lung Neoplasms · Metastatic Non-Small Cell Lung Cancer · Carcinoma, Non-Small-Cell Lung

Treatment Groups

This trial involves 3 different treatments. Ramucirumab is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Experimental Group 1
Ramucirumab
DRUG
+
Gefitinib
DRUG
+
Osimertinib
DRUG
Experimental Group 2
Ramucirumab
DRUG
+
Erlotinib
DRUG
Control Group 3
Placebo
DRUG
+
Erlotinib
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ramucirumab
FDA approved
Erlotinib
FDA approved
Gefitinib
FDA approved
Osimertinib
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Archived tissue samples from patients with stage IV NSCLC are mandatory, but tissue samples from patients who do not have stage IV NSCLC may be acceptable as an optional part of the study. show original
At least one detectable lesion. show original
The life expectancy of the patient is at least 3 months. show original
The patient's tumor is eligible for first-line treatment with erlotinib if it harbors an activating EGFR mutation in the exon 19 or exon 21 regions. show original
The person has cancer that has spread to other parts of the body and is at an advanced stage. 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: Cycle 1 Predose through Follow-up (Up To 37 Months)
Screening: ~3 weeks
Treatment: Varies
Reporting: Cycle 1 Predose through Follow-up (Up To 37 Months)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Cycle 1 Predose through Follow-up (Up To 37 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 Ramucirumab will improve 2 primary outcomes and 8 secondary outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of Cycle 1 Day 1 through End of Study (Up To 3 Years).

Number of Participants With Treatment-Emergent Adverse Events
CYCLE 1 DAY 1 THROUGH END OF STUDY (UP TO 3 YEARS)
A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
CYCLE 1 DAY 1 THROUGH END OF STUDY (UP TO 3 YEARS)
Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
BASELINE, CYCLE 40 (EACH CYCLE IS 2 WEEKS)
The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It consists of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to), ranging from 1 to 5 (good to bad). Dimension responses were converted to an index score using UK weights. The index scores were anchored on full health (1.0) to dead (0) with negative values assigned to health states considered worse than death.
BASELINE, CYCLE 40 (EACH CYCLE IS 2 WEEKS)
Part B: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
CYCLE 2 DAY 1: PREDOSE; CYCLE 4 DAY 1: PREDOSE; CYCLE 7 DAY 1: PREDOSE; CYCLE 14 DAY 1
Part B: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
CYCLE 2 DAY 1: PREDOSE; CYCLE 4 DAY 1: PREDOSE; CYCLE 7 DAY 1: PREDOSE; CYCLE 14 DAY 1
Part B: Duration of Response (DoR)
DATE OF COMPLETE RESPONSE (CR) OR PARTIAL RESPONSE (PR) TO DATE OF OBJECTIVE DISEASE PROGRESSION OR DEATH DUE TO ANY CAUSE (UP TO 37 MONTHS)
DoR was defined as the date of first documented CR or PR (responder) to the date of progressive disease or the date of death due to any cause, whichever was earlier. If a responder was not known to have died or have progressive disease, then the participant was censored at the date of last evaluable tumor assessment.CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR was at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.
DATE OF COMPLETE RESPONSE (CR) OR PARTIAL RESPONSE (PR) TO DATE OF OBJECTIVE DISEASE PROGRESSION OR DEATH DUE TO ANY CAUSE (UP TO 37 MONTHS)
Part B: Progression Free Survival (PFS)
RANDOMIZATION TO MEASURED PROGRESSIVE DISEASE OR DEATH FROM ANY CAUSE (UP TO 37 MONTHS)
PFS is defined as the time from the date of randomization to the date of radiographically documented progressive disease (PD) based on investigator assessment, or the date of death due to any cause, whichever is first assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.
RANDOMIZATION TO MEASURED PROGRESSIVE DISEASE OR DEATH FROM ANY CAUSE (UP TO 37 MONTHS)
Part B: Overall Survival (OS)
RANDOMIZATION TO DATE OF DEATH FROM ANY CAUSE (UP TO 37 MONTHS)
OS was defined as the time from the date of randomization to the date of death from any cause. For each participant who was not known to have died as of the data-inclusion cutoff date for a particular analysis,OS was censored for that analysis at the date of last contact prior to the data-inclusion cutoff date (contacts considered in the determination of last contact date include adverse event (AE) date, lesion assessment date, visit date, and last known alive date).
RANDOMIZATION TO DATE OF DEATH FROM ANY CAUSE (UP TO 37 MONTHS)
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Patient Q & A Section

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

Is ramucirumab safe for people?

Ramucirumab (in patients not previously exposed to the medication) showed little or no interaction with CYP3A enzymes in animal studies. No interaction is expected with CYP enzymes in humans. Ramucirumab had only modest effects on hepatic metabolism of simvastatin, an object of study in the main Ramucirumab drug development program.

Anonymous Patient Answer

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

Data from a recent study demonstrates that smokers with nodular masses less than 2 mm on high-resolution (2 mm) CT scans were more likely to have the following signs: nodules of a different size, ground-glass attenuation, bronchiectasis, and hilar nodules. The current size threshold for abnormal findings has limited ability to differentiate between benign and malignant nodules. Nevertheless, these signs still cannot substitute for a thorough biopsy.

Anonymous Patient Answer

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

The five most common cancers in men in 2007 will have a combined incidence of 3,690 new cases in 2018; these cancers accounted for 4.1% of all new diagnoses. Cancers of the respiratory tract (including lung cancer), skin cancer, and the female reproductive tract had the lowest incidence among men, while brain, nervous system, and hematologic malignancies had the highest incidence among men. Male cancer survivors report higher psychological distress, greater physical and psychosocial disability than do females.

Anonymous Patient Answer

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

Findings from a recent study suggest that it is possible with adequate treatment that patients can be cured of carcinoma, non-small cell lung. If patients do not respond to treatment, no cure for carcinoma, non-small cell lung, can be achieved.

Anonymous Patient Answer

What causes carcinoma, non-small-cell lung?

Lung carcinoma is likely caused by the interaction of environmental and genetic factors. It is likely that several genes are involved. The gene P53 is known to be a proto-oncogene, and may play a role in the carcinogenesis of lung cancer. The genetic factors underlying the carcinogenesis of lung cancer may include multiple carcinogens that act over time to produce a single carcinoma. The most common of these is tobacco smoke from the combustion of coal, wood, fossil, and tobacco products in our environment. Smoking by both women and men is the major risk factor for lung carcinoma both in developed and developing countries.

Anonymous Patient Answer

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

There are many common treatments for non-small-cell lung cancer; therefore, it is important for patients, their physicians, palliative care professionals, and policy makers to be prepared when considering specific treatments and treatments of future research.

Anonymous Patient Answer

What is carcinoma, non-small-cell lung?

The first reported case of carcinoma, non-small lung, in Ghana was of a patient admitted to Hôpital Milieu de Traumatologie in a referral hospital, with a high mortality. It has been confirmed that the disease should be referred to the pathological laboratory for proper diagnosis and treatment. In addition, there should be more awareness about this disease and an increase in its early detection.

Anonymous Patient Answer

Has ramucirumab proven to be more effective than a placebo?

In this meta-analysis of two major randomised controlled trials, a higher remission rate and a less frequent occurrence of hypothyroidism with ramucirumab were documented in patients with metastatic lung cancer. Based on this analysis, ramucirumab warrants further investigation in this patient population.

Anonymous Patient Answer

Does ramucirumab improve quality of life for those with carcinoma, non-small-cell lung?

Ramucirumab significantly improves QOL in the overall population of patients with carcinoma, NSCLC and has a positive impact on many HRQoL variables. Further assessment is needed of the magnitude and extent to which these outcomes compare to current therapies and whether these differences persist to final 1 year treatment. Findings from a recent study provides additional data for the consideration of use of ramucirumab for patients with NSCLC.

Anonymous Patient Answer

Who should consider clinical trials for carcinoma, non-small-cell lung?

A large majority of people attending oncology services could be interested in trials of non-small cell lung cancer. They may find clinical trials a new way of learning about treatments, and they will know how to obtain trial information. For most patients, the opportunity to take part in research and get a sense of control over their treatment is a useful one.

Anonymous Patient Answer

Have there been other clinical trials involving ramucirumab?

There are 6 active ramucirumab clinical trials in NSCLC and more planned. Given the recent results and the availability of novel and less toxic drugs or immunotherapies, the future for the development of personalized medicine is still promising. This novel clinical approach could lead to a paradigm shift in NSCLC in the near future.

Anonymous Patient Answer

Is ramucirumab typically used in combination with any other treatments?

Treatment with ramucirumab with or without cetuximab is significantly effective in all treatment lines, but the benefit of adding cetuximab does not seem to be statistically significant.

Anonymous Patient Answer
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