CLINICAL TRIAL

Sitravatinib for Carcinoma, Non-Small-Cell Lung

Metastatic
Newly Diagnosed
Recurrent
Stage III
Recruiting · 18+ · All Sexes · New Haven, CT

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

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

Eligible Conditions
Sitravatinib · Carcinoma, Non-Small-Cell Lung · Lung Neoplasms · Lung Diseases · Carcinoma · Advanced Treatment-Naïve PD-L1 · Metastatic Lung Non-Small Cell Carcinoma · Stage IV Non-Small Cell Lung Cancer AJCC v7 · Pembrolizumab · PD-L1 Gene Mutation

Treatment Groups

This trial involves 4 different treatments. Sitravatinib is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Pembrolizumab
DRUG
+
Sitravatinib
DRUG
Experimental Group 2
Pembrolizumab
DRUG
+
Sitravatinib
DRUG
Experimental Group 3
Pembrolizumab
DRUG
+
Sitravatinib
DRUG
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Sitravatinib
Not yet FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Carcinoma, Non-Small-Cell Lung or one of the other 9 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:
PD-L1 ≥ 1% using the 22c3 PD-L1 IHC assay or a local assay performed in a CLIA facility
Age ≥ 18 years.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Absolute neutrophil count >1,500/mm3 (1.5 × 10^9/L).
Hemoglobin ≥ 8.0 g/dL not dependent on transfusion support.
Platelet count ≥ 75 × 10^9/L (≥ 75,000 per mm3).
Histologically or cytologically confirmed non-squamous NSCLC that is metastatic (Stage IV), recurrent, or unresectable locally advanced (Stage IIIB/IIIC) disease, not amenable to treatment with curative intent.
Life expectancy of at least 3 months.
Measurable disease as per RECIST v1.1
No prior systemic therapy for advanced disease. Prior chemotherapy for local or locally advanced disease is allowed if completed >6 months prior to trial enrollment. Prior immunotherapy is not allowed.
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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: 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 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 Sitravatinib will improve 1 primary outcome and 5 secondary outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of 2 years.

Incidence of Adverse Events as per CTCAE v.5
2 YEARS
Evaluation of the safety and toxicity profile of the combination of sitravatinib and pembrolizumab in the first-line treatment of patients with non-squamous metastatic NSCLC is a secondary objective in this study. Secondary endpoint is adverse events as per CTCAE v.5. The Safety population is defined as all patients who received any dose of study treatment (i.e., sitravatinib and/or pembrolizumab) and will be used for all safety analyses.
2 YEARS
Clinical Benefit Rate (CBR)
2 YEARS
Clinical Benefit Rate (CBR) in Group A is a secondary endpoints for this study, while CBR in Group B is an exploratory endpoint.
2 YEARS
Overall Survival (OS)
2 YEARS
Overall Survival (OS) in the main study populations (ie groups 1A and 2A) is a secondary endpoint for this study. OS in groups 1B and 2B is an exploratory endpoint.
2 YEARS
Progression Free Survival (PFS)
2 YEARS
Progression Free Survival (PFS) in the main study populations (ie groups 1A and 2A) is a secondary endpoint for this study. PFS in groups 1B and 2B is an exploratory endpoint.
2 YEARS
Objective Response Rate (ORR)
2 YEARS
(1) Objective Response Rate (ORR): The primary endpoint for this study will be ORR as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in the main study population.
2 YEARS
Duration of Response (DOR)
2 YEARS
Duration of Response (DOR) for patients in Group A is a secondary endpoints for this study; DOR for Group B is an exploratory endpoint.
2 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 are the signs of carcinoma, non-small-cell lung?

Recent findings suggests that the clinical manifestations of carcinoma, non-small-cell lung were more common in young women and those with smoking history than in elderly and non-smoking ones; there were also differences between smokers and non-smokers regarding gender distribution and site. It might be worthwhile to conduct a large-scale epidemiologic survey on this topic in order to better understand the characteristics of carcinoma, non-small-cell lung.

Anonymous Patient Answer

Has sitravatinib proven to be more effective than a placebo?

Sitravatinib did not outperform placebo in terms of PFS or OS. The study was underpowered for OS; however, our results suggest that further larger prospective studies in patients with advanced NSCLC may be warranted.

Anonymous Patient Answer

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

Lung carcinoma incidence among whites was higher than reported incidence of lung carcinoma among blacks and Hispanics in the US. The leading cause of death from lung carcinoma was lung adenocarcinoma among whites. If these disparities continue, there will be an increasing burden of lung cancer mortality among black and Hispanic Americans.

Anonymous Patient Answer

What does sitravatinib usually treat?

Sitratavinib decreases PSA levels up to 65% after 2 weeks of continuous dosing, but no significant reductions are seen at steady state. The drug has been found to inhibit TMPRSS8 (also known as MMP17) and also shows some activity against telomerase, a key enzyme involved in cellular division. There is limited evidence that it may also reduce cell growth and migration in vitro. The data suggest that sitravatinib might be useful for the treatment of certain types of breast cancer.

Anonymous Patient Answer

Is sitravatinib safe for people?

The tolerability profile of sitravatinib appears similar to other agents in this class, including imatinib. Findings from a recent study suggest that sitravatinib may be safer than other agents in this class for the treatment of CML and GIST.

Anonymous Patient Answer

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

In a recent study, we found significant differences between pre-existing smokers and non-smokers in both carcinoma and non-carcinoma groups. The data obtained suggest that smokers who develop NSCLC may be at higher risk of developing SCC compared with nonsmokers. It seems that smokers who develop carcinoma are more likely to develop SCC than non-smokers. Therefore, it is advisable for physicians to take all smokers into consideration when selecting a treatment strategy for NSCLC patients.

Anonymous Patient Answer

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

There was no difference between genders in survival rates. Patients younger than 50 years had higher 5-year survival. Male patients over 65 years had better results than females. For carcinoma, NSCLC patients with stage IIIB+IIIC disease, but not with stage I+IIIA disease, had better survival. Survival was worse for patients with a node metastasis.

Anonymous Patient Answer

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

The mean age at diagnosis was 64 years old (SD = 9.6 years). Most people were diagnosed with early stage disease (stage I and II) although there was a small proportion of late stage disease (stage III and IV). Age did not appear to affect survival, with the exception of older patients who survived longer after diagnosis compared with younger patients.

Anonymous Patient Answer

What are the latest developments in sitravatinib for therapeutic use?

Sitreavatinib represents a novel oral, small molecule inhibitor of blood vessel formation that has demonstrated potent antiangiogenic properties in preclinical models of solid tumors. Results from a recent clinical trial suggest that further evaluation of sitreavatinib as an antiangiogenic agent alone or in combination with conventional anticancer agents is warranted.

Anonymous Patient Answer

What are the common side effects of sitravatinib?

Sitravatinib shows potential for treating cancers with PTEN mutation, especially NSCLC. The most commonly reported side effects in patients treated with sitravatinib include fatigue, nausea, vomiting, diarrhea, constipation, abdominal pain, headache, dizziness, cough, and rash. For those who develop these symptoms while on sitravatinib, they should seek medical attention.

Anonymous Patient Answer
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