Cobolimab for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Non-Small Cell Lung CancerCobolimab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer treatment involving two drugs and chemotherapy for people with advanced lung cancer who have not responded to a different anti-PD-(L)1 drug.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 19 Secondary · Reporting Duration: Up to 44 months

Month 44
Change from Baseline in the EORTC QLQ LC13 assessment
Change from Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 item Core Module (EORTC QLQ-C30) assessment
Day 30
Number of participants with adverse events (AEs) leading to discontinuation
Number of participants with treatment-emergent adverse events (TEAEs) and immune related adverse event (irAEs)
Day 90
Number of participants with TEAEs leading to death
Number of participants with abnormal findings in Electrocardiogram (ECG) Parameters
Number of participants with abnormal findings in vital signs
Number of participants with abnormal physical examinations
Number of participants with clinically significant changes in hematology, clinical chemistry, thyroid function and urinalysis lab parameters
Number of participants with clinically significant changes in vital signs and Electrocardiogram (ECG) Parameters
Number of participants with indicated Eastern Cooperative Oncology Group (ECOG) performance status
Number of participants with serious adverse events (SAEs)
Therapeutic procedure
Number of participants with usage of concomitant medications
Up to 44 months
Duration of response (DOR)
OS in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving dostarlimab + docetaxel
OS in participants receiving dostarlimab + docetaxel relative to participants receiving docetaxel alone
Objective response rate (ORR)
Overall survival (OS) in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving docetaxel alone
Progression free survival (PFS)
Time to deterioration (TTD)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Trastuzumab
59%Leukopenia
56%Neutropenia
34%Hypoaesthesia
31%Agranulocytosis
22%Alopecia
22%Asthenia
19%Pyrexia
16%Nail disorder
16%Hypophagia
16%Oedema peripheral
16%Diarrhoea
13%Cough
13%Vomting
13%Alanine aminotransferase increased
13%Neurotoxicity
9%Headache
9%Rash
9%Chest discomfort
9%Anaemia
9%Nausea
9%Bone marrow failure
9%Aspartate aminotransferase increased
9%Musculoskeletal pain
9%Pigmentation disorder
6%Insomnia
6%Transaminases increased
6%Paronychia
6%Flushing
6%Thrombocytopenia
6%Face oedema
6%Nasopharyngitis
6%Mouth ulceration
6%Constipation
3%Completed suicide
3%Cataract
3%Infection
3%Upper respiratory tract infection
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT01301729) in the Trastuzumab ARM group. Side effects include: Leukopenia with 59%, Neutropenia with 56%, Hypoaesthesia with 34%, Agranulocytosis with 31%, Alopecia with 22%.

Trial Design

3 Treatment Groups

Participants receiving docetaxel
1 of 3
Participants receiving cobolimab+dostarlimab+docetaxel
1 of 3
Participants receiving dostarlimab+docetaxel
1 of 3

Active Control

Experimental Treatment

750 Total Participants · 3 Treatment Groups

Primary Treatment: Cobolimab · No Placebo Group · Phase 2 & 3

Participants receiving cobolimab+dostarlimab+docetaxelExperimental Group · 3 Interventions: Dostarlimab, Cobolimab, Docetaxel · Intervention Types: Biological, Biological, Drug
Participants receiving dostarlimab+docetaxelExperimental Group · 2 Interventions: Dostarlimab, Docetaxel · Intervention Types: Biological, Drug
Participants receiving docetaxel
Drug
ActiveComparator Group · 1 Intervention: Docetaxel · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 44 months

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,650 Previous Clinical Trials
7,949,315 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,561 Previous Clinical Trials
6,132,731 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a disease that can be measured.
You have an ECOG performance status score of 0 or 1.