Study of Bevacizumab in Combination With Chemoimmunotherapy and Atezolizumab in Patients With Extensive Stage Small Cell Lung Cancer and Liver Metastases

Part of paid clinical trials in Los Angeles, California.

Sponsor
Kamya Sankar
Study ID
NCT05588388
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Extensive-stage Small-cell Lung Cancer
  • Liver Metastases

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Addition of Bevacizumab to current standard of care treatment (atezolizumab, carboplatin and etoposide) followed by maintenance Bevacizumab plus Atezolizumab for patients with ES-SCLC with LM

Study Details

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.

Key Dates

Start date
Aug 11, 2024
Status verified
Nov 2025
Primary completion
Dec 28, 2026
Completion
Dec 28, 2027

Study Design

Enrollment
39 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Treatment
    1. Induction (ABCE): Atezolizumab 1200 mg, Bevacizumab 15 mg/kg, Carboplatin AUC5, Etoposide 100 mg/m2, given IV Q3weeks 2. Maintenance (AB): Atezolizumab 1200 mg and Bevacizumab 15 mg/kg given IV Q3weeks for 1 year, or until disease progression, or unacceptable toxicity

Primary Outcome Measure

6- month Progression Free Survival (PFS) rate [ Time Frame: Start of study treatment to 6-months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer InstituteLos AngelesCalifornia90048
Amy Oppenheim
[email protected]
310-423-3713
Kamya Sankar, MD (PRINCIPAL_INVESTIGATOR)
Sukhmani Padda, MD (SUB_INVESTIGATOR)
Ronald Natale, MD (SUB_INVESTIGATOR)
Karen Reckamp, MD (SUB_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Dominique Dippman
[email protected]
Angel Qin, MD (PRINCIPAL_INVESTIGATOR)
Gregory P. Kalemkerian, MD (SUB_INVESTIGATOR)
V.A. Ann Arbor Healthcare SystemAnn ArborMichigan48105
Brittany Pannecouk, BS
[email protected]
734-845-3966
Melissa Robinson, MPH
[email protected]
734-222-7474
Nithya Ramnath, MBBS (PRINCIPAL_INVESTIGATOR)
Garth W Strohbehn, MD (SUB_INVESTIGATOR)
Michael D Green, MD PhD (SUB_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute· Los Angeles, CAUniversity of Michigan· Ann Arbor, MIV.A. Ann Arbor Healthcare System· Ann Arbor, MI

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