Sitravatinib for Non-Small Cell Lung Cancer

Smilow Cancer Center/Yale-New Haven Hospital, New Haven, CT
Non-Small Cell Lung Cancer+8 More ConditionsSitravatinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new combination of drugs to treat non-squamous NSCLC that is positive for PD-L1.

Eligible Conditions
  • Stage IV Non-small Cell Lung Cancer
  • PD-L1 Gene Mutation
  • Non-Small Cell Lung Cancer
  • Advanced Treatment-Naïve Programmed Death-Ligand 1 (PD-L1)
  • Sitravatinib
  • Pembrolizumab
  • Lung Cancer
  • Lung Disease
  • Non-Small Cell Lung Cancer (NSCLC)

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 2 years

2 years
Clinical Benefit Rate (CBR)
Duration of Response (DOR)
Incidence of Adverse Events as per CTCAE v.5
Objective Response Rate (ORR)
Overall Survival (OS)
Progression Free Survival (PFS)

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

4 Treatment Groups

Group 1B: PD-L1 1-49%, Pembrolizumab run-in population
1 of 4
Group 2A: PD-L1 ≥ 50%, Main Study Population
1 of 4
Group 2B: PD-L1 ≥ 50%, Pembrolizumab run-in population
1 of 4
Group 1A: PD-L1 1-49%, Main Study Population
1 of 4

Experimental Treatment

70 Total Participants · 4 Treatment Groups

Primary Treatment: Sitravatinib · No Placebo Group · Phase 2

Group 1B: PD-L1 1-49%, Pembrolizumab run-in populationExperimental Group · 2 Interventions: Sitravatinib, Pembrolizumab · Intervention Types: Drug, Drug
Group 2A: PD-L1 ≥ 50%, Main Study PopulationExperimental Group · 2 Interventions: Sitravatinib, Pembrolizumab · Intervention Types: Drug, Drug
Group 2B: PD-L1 ≥ 50%, Pembrolizumab run-in populationExperimental Group · 2 Interventions: Sitravatinib, Pembrolizumab · Intervention Types: Drug, Drug
Group 1A: PD-L1 1-49%, Main Study PopulationExperimental Group · 2 Interventions: Sitravatinib, Pembrolizumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sitravatinib
Not yet FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Mirati Therapeutics Inc.Industry Sponsor
64 Previous Clinical Trials
7,624 Total Patients Enrolled
Sarah GoldbergLead Sponsor
Sarah Goldberg, MD MPHPrincipal InvestigatorYale University

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for at least 3 more months.

Frequently Asked Questions

Are there any vacancies remaining in this research protocol?

"Affirmative. According to information accessible on clinicaltrials.gov, this experiment is actively recruiting patients and was initially shared on February 10th 2022 with its most recent update occurring October 26th of the same year. 70 research participants are required from 3 different sites." - Anonymous Online Contributor

Unverified Answer

How many individuals are currently participating in this clinical experiment?

"Affirmative, clinicaltrials.gov details that this medical study is actively looking to recruit patients since its first posting on February 10th 2022 and latest update on October 26th 2022. 70 individuals must be enrolled at 3 sites for the trial's completion." - Anonymous Online Contributor

Unverified Answer

Could you provide a summary of the research conducted on Pembrolizumab?

"Currently, there are 975 clinical trials exploring the efficacy of Pembrolizumab treatment. Of these studies, 124 have reached Phase 3 and many of them originate from Houston, Texas. However, there exists a global network with 36150 sites running research for this medication." - Anonymous Online Contributor

Unverified Answer

How is Pembrolizumab utilized to treat medical conditions?

"Pembrolizumab is typically used to battle malignant neoplasms, although it has also been known to be successful in treating unresectable melanoma, microsatellite instability high, or chemotherapy-resistant diseases." - Anonymous Online Contributor

Unverified Answer

Has Pembrolizumab been granted sanction by the FDA?

"Our Power team evaluated pembrolizumab's safety as a 2, owing to the fact that Phase 2 data only provide insight into its security profile and not its efficacy." - 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.