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Alkylating agents

Tobemstomig + Chemotherapy vs Pembrolizumab + Chemotherapy for Lung Cancer

Phase 2

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

Measurable disease

Known tumor PD-L1 status

Must not have

Known hypersensitivity to Chinese hamster ovary cell products or to any component of the tobemstomig or pembrolizumab formulation

Active tuberculosis (TB) or untreated latent TB

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called tobemstomig combined with chemotherapy for advanced lung cancer patients who can't have surgery or standard treatments. The goal is to see if this combination works better than the current standard treatment.

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer (NSCLC) who haven't had treatment yet. They should have a life expectancy of at least 12 weeks, no HIV or hepatitis, good heart function, and be generally well enough to perform daily activities with ease (ECOG status 0-1). People can't join if they've had certain other cancers recently, autoimmune diseases, organ transplants, severe infections or allergies related to the treatments being tested.

What is being tested?

The study compares Tobemstomig combined with platinum-based chemotherapy against Pembrolizumab with the same chemo in patients with untreated NSCLC. It aims to see which combination works better and is safer while also checking how the body processes these drugs.

What are the potential side effects?

Possible side effects include allergic reactions to medication components, immune system-related issues like inflammation in various organs due to checkpoint inhibitors like Pembrolizumab and Tobemstomig. Chemotherapy may cause nausea, fatigue, hair loss 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 can be measured by tests.

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I know my cancer's PD-L1 status.

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I haven't received any systemic treatment for my advanced lung cancer.

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My lung cancer is advanced and cannot be removed by surgery or completely treated with chemotherapy and radiation.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I am allergic to certain medication ingredients, including those from Chinese hamster ovary cells.

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I have active or untreated latent tuberculosis.

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I am not allergic to any chemotherapy drugs I might receive in the study.

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I have a history of lung scarring or inflammation not caused by infections.

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I have had cancer spread to the lining of my brain and spinal cord.

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I have not treated or have unstable pressure on my spinal cord.

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I have previously received treatments targeting the immune system.

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I have had a previous transplant of stem cells or an organ.

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I have or had an autoimmune disease or immune deficiency.

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I have not had any cancer other than non-small cell lung cancer in the last 5 years.

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I have brain metastases that are untreated or getting worse.

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I am currently on medication for hepatitis B or C.

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I have not received a live vaccine in the last 4 weeks and do not plan to during or within 5 months after the study.

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My lung cancer has an EGFR mutation or ALK fusion.

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I have pain from my cancer that isn't relieved by treatment.

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I have high calcium levels in my blood that are causing symptoms.

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I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.

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I frequently need procedures to remove excess fluid from my body.

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I haven't taken any immune-weakening drugs in the last 2 weeks and don't expect to need any during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A: Tobemstomig + Platinum-Based ChemotherapyExperimental Treatment4 Interventions

Participants with non-squamous (NSQ) NSCLC will receive induction treatment with blinded tobemstomig in combination with pemetrexed and carboplatin, all on Day 1 every 3 weeks (Q3W) for four 21-day cycles, followed by Q3W maintenance therapy with blinded tobemstomig together with pemetrexed until disease progression or treatment discontinuation. Participants with squamous (SQ) NSCLC will receive blinded tobemstomig in combination with paclitaxel and carboplatin, all on Day 1 Q3W for four 21 day cycles, followed by blinded tobemstomig (on Day 1) Q3W until disease progression or treatment discontinuation.

Group II: Arm B: Pembrolizumab + Platinum-Based ChemotherapyActive Control4 Interventions

Participants with NSQ NSCLC will receive induction treatment with blinded pembrolizumab in combination with pemetrexed and carboplatin, all on Day 1 Q3W for four 21-day cycles, followed by a maintenance therapy with blinded pembrolizumab together with pemetrexed Q3W until disease progression or treatment discontinuation. Participants with SQ NSCLC will receive blinded pembrolizumab in combination with paclitaxel and carboplatin, all on Day 1 Q3W for four 21-day cycles, followed by blinded pembrolizumab (on Day 1) Q3W until disease progression or treatment discontinuation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5370

Pemetrexed

2014

Completed Phase 3

~5550