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Monoclonal Antibodies

Novel Drug Regimens for Lung Cancer

Phase 2
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with histologically or cytologically confirmed diagnosis of NSCLC (squamous or non-squamous)
Male or female, aged 18 years or older at the time consent is obtained. Participants in Korea must be age 19 years or older at the time consent is obtained
Must not have
Major surgery less than or equal to (<=) 28 days of first dose of study treatment
Received greater than (>)2 prior lines of therapy for NSCLC, including participants with BRAF molecular alternations
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing new treatment plans that include a drug called belrestotug. It targets patients with advanced lung cancer that has come back or hasn't responded to other treatments. The goal is to see if these new plans work better than the usual treatments.

Who is the study for?
Adults with advanced non-small cell lung cancer (NSCLC) who've had disease progression after standard treatments, including a platinum-based chemotherapy and PD(L)1 inhibitor therapy. They must have measurable disease, be in good physical condition (ECOG score of 0 or 1), and have proper organ function. Women participating should not be pregnant or breastfeeding and must follow contraceptive guidance if of childbearing potential.
What is being tested?
The trial is testing new treatments against the standard care for NSCLC that has relapsed or is refractory. It includes novel regimens either combined or as single agents. Part 1 assesses safety and pharmacokinetics, while Part 2 compares efficacy in a randomized phase II study.
What are the potential side effects?
Potential side effects may include typical reactions to monoclonal antibodies such as infusion-related reactions, immune system effects like inflammation in various organs, fatigue, possible blood disorders, increased risk of infections due to immunosuppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer diagnosis was confirmed through lab tests.
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I am 18 years or older, or 19 if I am in Korea.
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My cancer progressed after treatment for my BRAF mutation.
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I am fully active or can carry out light work.
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My cancer has worsened after up to 2 treatments, including platinum and PD-L1 therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had major surgery within the last 28 days.
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I have had more than 2 treatments for non-small cell lung cancer.
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I have had a bone marrow or organ transplant in the past.
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I haven't taken any cancer drugs in the last 30 days or 5 half-lives, whichever is shorter.
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I haven't had serious heart or unstable liver issues in the last 6 months.
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I haven't received blood products or specific medications to stimulate blood cell production within the last 14 days.
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I am not on strong medication affecting liver enzymes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part 2: Overall survival
Secondary study objectives
Part 1: Disease control rate (DCR)
Part 1: Objective response rate
Part 2: DCR
+9 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Part 2: Participants receiving feladilimab and docetaxelExperimental Treatment2 Interventions
Group II: Part 1: Participants receiving feladilimab and ipilimumabExperimental Treatment2 Interventions
Group III: Part 1: Participants receiving dostarlimab plus GSK4428859A/EOS884448/belrestotug plus GSK6097608Experimental Treatment3 Interventions
Group IV: Part 1: Participants receiving dostarlimab plus GSK4428859A/EOS884448/belrestotugExperimental Treatment2 Interventions
Group V: Part 2: Participants receiving SoC: docetaxelActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~6550
Feladilimab
2019
Completed Phase 2
~110
Ipilimumab
2015
Completed Phase 3
~3420
Dostarlimab
2020
Completed Phase 3
~1760

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,807 Previous Clinical Trials
8,381,133 Total Patients Enrolled
5 Trials studying Tumors
1,919 Patients Enrolled for Tumors
iTeos Belgium SAIndustry Sponsor
7 Previous Clinical Trials
676 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,604 Previous Clinical Trials
6,144,533 Total Patients Enrolled
1 Trials studying Tumors
12 Patients Enrolled for Tumors

Media Library

Cobolimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03739710 — Phase 2
Tumors Research Study Groups: Part 2: Participants receiving feladilimab and docetaxel, Part 1: Participants receiving dostarlimab plus GSK4428859A/EOS884448/belrestotug, Part 1: Participants receiving dostarlimab plus GSK4428859A/EOS884448/belrestotug plus GSK6097608, Part 2: Participants receiving SoC: docetaxel, Part 1: Participants receiving feladilimab and ipilimumab
Tumors Clinical Trial 2023: Cobolimab Highlights & Side Effects. Trial Name: NCT03739710 — Phase 2
Cobolimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03739710 — Phase 2
~17 spots leftby Jul 2025
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