Experimental Treatment for Small cell carcinoma of lung

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Small cell carcinoma of lung+5 More
Bevacizumab - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This clinical trial aims to assess whether the addition of bevacizumab to atezolizumab and chemotherapy can improve response to treatment and progression-free survival in patients with extensive-stage small cell lung cancer (ES-SCLC) with liver metastases. The main questions it aims to answer are: In patients with ES-SCLC with liver metastases, can bevacizumab in combination with atezolizumab and chemotherapy prolong the length of time that the cancer does not progress? Is bevacizumab safe and tolerable when combined with atezolizumab and chemotherapy in patients with ES-SCLC and liver metastases? The study treatment includes two phases: Induction phase: bevacizumab will be administered in combination with atezolizumab and chemotherapy on a 21-day cycle for four cycles. Maintenance: atezolizumab and bevacizumab will be administered every 21 days for up to 12 months, or until unacceptable toxicity or disease progression. Participants will undergo blood tests every 3 weeks and tumor assessments every 6 weeks.

Eligible Conditions
  • Small cell carcinoma of lung
  • Hepatic Metastases

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: From time of first dose until death from any cause, assessed up to approximately 48 months

Month 15
Tissue and blood based biomarkers
Month 48
Incidence of adverse events
Month 48
Overall Survival (OS)
Month 48
Progression Free Survival (PFS)
Month 48
Objective Response Rate
Start of study treatment to 6-months
6- month Progression Free Survival (PFS) rate

Trial Safety

Safety Progress

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

Side Effects for

Bevacizumab
22%vitreous hemorrhage
17%worsening of cataract
9%vitreous syneresis
9%posterior capsule opacification
4%pyelonephritis
4%pneumonia
4%colon cancer
4%cranial nerve VI palsy
4%bradycardia
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT02036424) in the Bevacizumab ARM group. Side effects include: vitreous hemorrhage with 22%, worsening of cataract with 17%, vitreous syneresis with 9%, posterior capsule opacification with 9%, pyelonephritis with 4%.

Trial Design

1 Treatment Group

Experimental Treatment
1 of 1

Experimental Treatment

39 Total Participants · 1 Treatment Group

Primary Treatment: Experimental Treatment · No Placebo Group · Phase 2

Experimental Treatment
Drug
Experimental Group · 1 Intervention: Bevacizumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2014
Completed Phase 4
~5320

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from time of first dose until death from any cause, assessed up to approximately 48 months

Who is running the clinical trial?

University of MichiganOTHER
1,619 Previous Clinical Trials
6,410,841 Total Patients Enrolled
Kamya SankarLead Sponsor
Genentech, Inc.Industry Sponsor
1,488 Previous Clinical Trials
563,916 Total Patients Enrolled
VA Ann Arbor Healthcare SystemFED
16 Previous Clinical Trials
5,018 Total Patients Enrolled
Kamya Sankar, MDPrincipal InvestigatorCedars-Sinai Cancer

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have the ability to sign an informed consent form and to comply with the requirements of the study.
You have a lung cancer that is histologically or cytologically confirmed to be small cell lung cancer.
You are eligible if you have history of EGFR mutant non-small cell lung cancer with histologically confirmed transformation to small cell lung cancer with presence of liver metastases, who are chemotherapy and immunotherapy naïve.
Metastases are limited to the cerebellum or supratentorial region.
Presence of measurable disease outside the CNS per RECIST v1.1.1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 7th, 2021

Last Reviewed: November 8th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.