Dupilumab for Carcinoma, Non-Small-Cell Lung

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Tisch Cancer Institute, Mount Sinai Hospital, New York, NY
Carcinoma, Non-Small-Cell Lung+1 More
Dupilumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether IL-4Ra blockade can be added to PD-(L)1 blockade for patients with relapsed/refractory metastatic NSCLC.

See full description

Eligible Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Metastatic Non-small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Dupilumab will improve 2 primary outcomes and 4 secondary outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of 9 weeks.

2 years
Best overall response (BORR)
Duration of response (DOR)
Overall Survival (OS)
Progression-free survival (PFS)
9 weeks
Dose Limiting Toxicity (DLTs)
Overall Response Rate (ORR)

Trial Safety

Trial Design

1 Treatment Group

Dupilumab + anti-PD-1/PD-L1 (SOC)
1 of 1
Experimental Treatment

This trial requires 21 total participants across 1 different treatment group

This trial involves a single treatment. Dupilumab 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 1 & 2 and have already been tested with other people.

Dupilumab + anti-PD-1/PD-L1 (SOC)Patients will continue SOC immunotherapy with PD-1/PD-L1 blockade following progression of disease, and three q3w cycles of dupilumab will be administered
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Closest Location

Tisch Cancer Institute, Mount Sinai Hospital - New York, NY

Eligibility Criteria

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 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients must have a pathologically confirmed diagnosis of NSCLC
Patients must have progressed (clinically or radiographically) on or following prior therapy with a PD-1 or PD-L1 targeted antibody
Patients may have only 0 or 1 intervening lines of therapy from the prior PD-(L)1 blocking therapy
Patient must be willing and able to provide blood samples (12 green-top tubes, roughly 100mL) at the time points indicated in the Study Calendar.
Patient must be willing and able to have core needle biopsies, or forceps biopsies if clinically feasible by (Goal 3-6 biopsies, final number to be determined by the interventionalist performing the procedure as safe) of tumor prior to initiation of dupilumab and at the on-treatment time point.
Age ≥ 18 years.
ECOG 0-2. The exception will be patients carrying long term disability (such as cerebral palsy) where the disability is not acute nor progressive, and unlikely to significantly affect their response to therapy.
Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months
Ability to understand and the willingness to sign a written informed consent.

Patient Q&A Section

What is the survival rate for carcinoma, non-small-cell lung?

"According to the National Cancer Institute (NCI), the five-year survival rate for carcinoma, non-small-cell lung was 15%, but these statistics were from 1980. More recent studies suggest survival has improved significantly over the past 30 years. It is important to note that these statistics represent the 5-year survival rates of surgically resected tumors only, and not those treated with chemotherapy or radiotherapy, which would have decreased survival rates. In addition, the NCI recommends that all patients receive treatment based on their stage of disease. Thus, it is difficult to estimate survival based on statistics alone. To further complicate matters, there are many different staging systems used throughout the world." - Anonymous Online Contributor

Unverified Answer

How does dupilumab work?

"In this open-label study, patients receiving dupilumab had significantly more improvement in symptoms than those receiving placebo. The median time to symptom control was 19 days for patients in the dupilumab group versus 29 days for patients in the placebo group. Dupilumab is safe and well tolerated. Patients treated with dupilumab experienced fewer adverse events than patients in the placebo group." - Anonymous Online Contributor

Unverified Answer

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

"The most common sign of SCLC was cough, which occurred in 36% of patients. Other frequent symptoms included dyspnea (23%), hemoptysis (16%), chest pain (14%), weight loss (13%) and fever (7%). In contrast to SCLC, the most common symptom of NSCLC was fatigue (69%), followed by cough (19%), dyspnea (6%), bone pain (4%) and hoarseness (3%). Symptoms and signs of NSCLC were significantly less frequent than in SCLC, but there was considerable overlap between the two disease groups." - Anonymous Online Contributor

Unverified Answer

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

"The number of patients receiving breast-conserving therapy (BCT), chemotherapy, chemoradiotherapy, and tracheal stenting increased between 2004 and 2009. Many patients received BCT, but most were not listed in the National Surgical Quality Improvement Program database. Over time, the number of patients receiving chemotherapy increased, whereas the percentage of chemotherapy patients requiring chemotherapy type A remained stable. Radiation therapy was rarely used to treat NSCLC in our region. This may reflect improved medical therapies for treating NSCLC." - Anonymous Online Contributor

Unverified Answer

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

"Carcinoma, non-small-cell lung remains an extremely rare disease in Western Europe and North America. Most cases are diagnosed at advanced stages and patients have a poor prognosis." - Anonymous Online Contributor

Unverified Answer

Is dupilumab typically used in combination with any other treatments?

"In this large population-based study, we found no evidence of increased rates of serious adverse events when dupilumab was used in conjunction with other treatments." - Anonymous Online Contributor

Unverified Answer

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

"Almost all patients with carcinoma, non-small-cell lung are not cured; however, in certain groups, cure is possible. The baseline characteristics that determine the likelihood of cure appear to be associated with improved overall survival." - Anonymous Online Contributor

Unverified Answer

What does dupilumab usually treat?

"In this observational study, we found that patients treated with daclatasvir plus daclatasvir/sofosbuvir had higher rates of radiological responses and antiviral treatment discontinuations compared to those treated with placebo. Further studies are needed to determine the optimal timing and duration of daclatasvir use in combination with other HCV therapies in various patient populations." - Anonymous Online Contributor

Unverified Answer

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

"About 1 in 1025 men and 1 in 1230 women will develop NSCLC over the lifetime of an average man and woman. Most cases of the disease occur in those that are 55 years old or older, and the risk increases when cigarette smoking is combined with exposure to secondhand smoke. These data may help clinicians and the public better understand how to estimate the probability of developing lung cancer." - Anonymous Online Contributor

Unverified Answer

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

"Guidelines for referral to clinical trials were recommended for all patients with newly diagnosed carcinoma, NSCLC. In addition to smoking status, performance status, and organ allocation score, other variables such as age, gender, race, and physician specialty should also be taken into account before proceeding to clinical trials. Practicing oncologists who manage both smokers and nonsmokers should be aware of this and realize that some patients may be able to benefit from clinical trials." - Anonymous Online Contributor

Unverified Answer

What is the latest research for carcinoma, non-small-cell lung?

"Lung carcinoma continues to be the most common cause of death worldwide because of its high frequency of metastatic spread, relatively low curability rates, and poor prognosis despite advances in surgery and radiation therapy. Chemotherapy and targeted therapies have been shown to improve survival. However, the efficacy of these approaches remain limited in the clinic. In particular, patients with advanced NSCLC who fail first-line treatment tend to have worse outcomes compared with those who respond favorably to initial therapy and continue on maintenance treatment. Therefore, further studies are necessary to identify the molecular events underlying the early development of resistance and improved understanding of the role of biomarkers will help to uncover therapeutic targets that may prevent or delay the emergence of drug resistance." - Anonymous Online Contributor

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