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Monoclonal Antibodies

Lurbinectedin + Atezolizumab for Small Cell Lung Cancer (IMforte Trial)

Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed ES-SCLC
No prior systemic therapy for ES-SCLC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months and 12 months after randomization
Awards & highlights

IMforte Trial Summary

This trial is testing lurbinectedin in combination with atezolizumab compared to atezolizumab alone as maintenance therapy in people with small-cell lung cancer.

Who is the study for?
This trial is for adults with extensive-stage small-cell lung cancer who've responded well or have stable disease after initial treatment with carboplatin, etoposide, and atezolizumab. They should be in good physical condition (ECOG PS of 0 or 1), have no prior systemic therapy for ES-SCLC, no active infections like HIV or hepatitis, and no history of certain autoimmune diseases or other cancers within the last five years.Check my eligibility
What is being tested?
The study tests if adding lurbinectedin to atezolizumab as a maintenance therapy offers more benefits compared to using atezolizumab alone after first-line induction therapy. Participants are randomly assigned to one of these two options following their initial response to treatment.See study design
What are the potential side effects?
Potential side effects include immune-related reactions due to atezolizumab such as inflammation in various organs, infusion reactions from both drugs, possible blood disorders, fatigue, digestive issues like nausea and diarrhea, and increased risk of infection.

IMforte Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is confirmed as small cell lung cancer through a biopsy.
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I have not had any treatment for my small cell lung cancer.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My blood and organs are healthy enough for specific cancer treatment.
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I haven't had chemo or radiotherapy for my small cell lung cancer in the last 6 months.

IMforte Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months and 12 months after randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months and 12 months after randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
IRF-Assessed Progression-Free Survival (PFS)
Overall Survival (OS)
Secondary outcome measures
Confirmed Objective Response Rate (ORR) as Determined by the IRF
Confirmed Objective Response Rate (ORR) as Determined by the Investigator
Duration of Response (DOR) as Determined by the IRF
+8 more

IMforte Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: Atezolizumab+LurbinectedinExperimental Treatment4 Interventions
Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle in combination with lurbinectedin on Day 1 of each 21-day cycle.
Group II: Arm B: AtezolizumabActive Control3 Interventions
Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Carboplatin
2014
Completed Phase 3
~6670
Lurbinectedin
2022
Completed Phase 2
~90
Etoposide
2010
Completed Phase 3
~2440

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,364 Total Patients Enrolled
Jazz PharmaceuticalsIndustry Sponsor
248 Previous Clinical Trials
33,669 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
887,812 Total Patients Enrolled

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05091567 — Phase 3
Small Cell Lung Cancer Research Study Groups: Arm A: Atezolizumab+Lurbinectedin, Arm B: Atezolizumab
Small Cell Lung Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT05091567 — Phase 3
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05091567 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the desired outcomes of this research?

"The primary objective of this trial, as measured over a Randomization to death from any cause interval (up to approximately 52 months), is IRF-Assessed Progression-Free Survival (PFS). Additionally, the trial will assess secondary outcomes including Duration of Response (DOR) and PFS Rates. DOR is defined as the time from the first occurrence of a documented confirmed objective response after randomization until disease progression or death from any cause, whichever occurs first. PFS rates are defined as the proportion of participants who have not experienced disease progression or death from any cause at 6 and 12 months after randomization. Finally"

Answered by AI

What is the official stance of the FDA on Lurbinectedin?

"Lurbinectedin has received a safety score of 3. This is based on the fact that it is currently in Phase 3 clinical trials, meaning that there are data supporting both its efficacy and safety."

Answered by AI

What are some of the common conditions that Lurbinectedin has been shown to improve?

"Lurbinectedin is an effective treatment option for patients with recurrent, advance directives, and advanced cervical cancer."

Answered by AI

Are researchers presently looking for more participants for this trial?

"Yes, that is correct. The listing on clinicaltrials.gov confirms that the trial is ongoing and recruiting patients. Originally posted on November 18th 2021, with the most recent update being October 27th 2022, the study is looking for 690 participants at 23 different sites."

Answered by AI

How many subjects are in this clinical trial?

"In order to carry out this study, 690 individuals who meet the pre-determined inclusion criteria are required. These participants can be recruited from one of several locations, including Cancer & Hematology Centers of Western Michigan; Spectrum Health Butterworth Research Pharmacy in Grand Rapids, Michigan and Mercy Research SPRG in Springfield, Missouri."

Answered by AI

Do different hospitals in this city have varied results from this study?

"Currently, this trial has 23 enrollees from places such as the Cancer & Hematology Centers of Western Michigan, Spectrum Health Butterworth Research Pharmacy in Grand Rapids, Mercy Research SPRG in Springfield, and Laura and ISAAC Perlmutter Cancer Center at NYU Langone. There are also 20 other sites still recruiting patients."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
Massachusetts
California
How old are they?
18 - 65
What site did they apply to?
Alabama Oncology
Rhode Island Hospital
Other
VA Greater Los Angeles
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+

Why did patients apply to this trial?

I initially did well with carboplatin, etopiside and tecentric. After 4 rounds of chemo I Started immunotherapy with tecentric which didn't work. I am now doing zepzelca.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Do you take patients from Romania?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer
2021. "A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05091567.
All > Lung Cancer Las Vegas
~185 spots leftby Apr 2025
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