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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two consecutive occasions at least 4 weeks apart after a complete response (cr) or partial response (pr) (up to 58 months)
Awards & highlights
Study Summary
This trial tests a drug for non-small-cell lung cancer, comparing it to an existing drug, to see how safe and effective it is.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ two consecutive occasions at least 4 weeks apart after a complete response (cr) or partial response (pr) (up to 58 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two consecutive occasions at least 4 weeks apart after a complete response (cr) or partial response (pr) (up to 58 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR)
Progression-free survival (PFS)
Secondary outcome measures
Area under the concentration-time curve (AUC) of Tobemstomig
Change in participant-reported outcomes as assessed by the use of the European Organisation for Research and Treatment (EORTC) item libraries
Clearance (CL) of Tobemstomig
+13 moreTrial 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
~5380
Pemetrexed
2014
Completed Phase 3
~5250
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,431 Previous Clinical Trials
1,089,888 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-LaRoche
2,201 Previous Clinical Trials
888,760 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any cancer treatments, including hormone therapy, in the last 21 days.My cancer can be measured by tests.I am allergic to certain medication ingredients, including those from Chinese hamster ovary cells.I have active or untreated latent tuberculosis.We need to make sure we have a sample of your tumor tissue for testing.I am not allergic to any chemotherapy drugs I might receive in the study.I know my cancer's PD-L1 status.I don't have any health issues that would make it unsafe for me to take a new drug.I haven't received any systemic treatment for my advanced lung cancer.I have a history of lung scarring or inflammation not caused by infections.I haven't taken any immune-boosting drugs in the last month or longer.I have not taken any strong antibiotics in the last 2 weeks.I have had cancer spread to the lining of my brain and spinal cord.My lung cancer is advanced and cannot be removed by surgery or completely treated with chemotherapy and radiation.I have not treated or have unstable pressure on my spinal cord.I have previously received treatments targeting the immune system.I have had a previous transplant of stem cells or an organ.I have or had an autoimmune disease or immune deficiency.I have not had any cancer other than non-small cell lung cancer in the last 5 years.I have brain metastases that are untreated or getting worse.I am currently on medication for hepatitis B or C.I have not had a severe infection in the last 4 weeks.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.I have not had serious heart problems in the last 3 months.My lung cancer has an EGFR mutation or ALK fusion.I have pain from my cancer that isn't relieved by treatment.You are expected to live for at least 12 more weeks.I have high calcium levels in my blood that are causing symptoms.I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.My heart is healthy and functions well.You do not have HIV, hepatitis B, or hepatitis C.You have had serious allergic reactions to certain types of medications in the past.I am fully active or can carry out light work.I frequently need procedures to remove excess fluid from my body.My blood and organs are functioning well.I haven't taken any immune-weakening drugs in the last 2 weeks and don't expect to need any during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: Pembrolizumab + Platinum-Based Chemotherapy
- Group 2: Arm A: Tobemstomig + Platinum-Based Chemotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA approved the combination of RO7247669 and platinum-based chemotherapy for therapeutic use?
"Our team has assigned Arm A: RO7247669 + Platinum-Based Chemotherapy a safety score of 2, since there is evidence for its security but no verifiable data confirming efficacy."
Answered by AI
How many individuals are partaking in this clinical experiment?
"Hoffmann-La Roche will oversee this trial, which requires the enrollment of 180 suitable patients to commence. The study will be conducted out of UZ Brussel in Brussels and UZ Leuven Gasthuisberg in Leuven."
Answered by AI
How many sites are currently involved in the implementation of this research project?
"22 trial sites are currently enrolling patients, with hubs located in Brussel, Leuven and Mechelen. To reduce the demands of travel, it is recommended to select a nearby site if you hope to take part."
Answered by AI
Are there still opportunities to participate in this trial for those seeking treatment?
"That is correct. According to clinicaltrials.gov, this experiment commenced on March 15th 2023 and has been actively recruiting since then with the most recent update being posted on May 17th 2023. 180 applicants from 22 different sites are sought after for enrolment in this trial."
Answered by AI
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