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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

Must not have

Treatment with therapeutic oral or IV antibiotics at the time of randomization

Receiving consolidative chest radiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months and 12 months after randomization

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking antibiotics through pills or IV.

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I am undergoing radiation therapy focused on my chest.

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I have had lung conditions like pulmonary fibrosis or pneumonitis.

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I have previously been treated with specific immune therapies or lurbinectedin/trabectedin.

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I have or had cancer spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months and 12 months after randomization

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

IRF-Assessed Progression-Free Survival (PFS)

Overall Survival (OS)

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Carboplatin

2014

Completed Phase 3