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Monoclonal Antibodies

Triple Therapy for Non-Small Cell Lung Cancer (COSTAR Lung Trial)

Phase 2 & 3

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant has received no more than 2 prior lines of therapy for advanced or metastatic disease, which must only include a platinum based doublet chemotherapy regimen and an anti-PD-1 or an anti-PD-(L)1 antibody.

Participant has measurable disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 44 months

Awards & highlights

COSTAR Lung Trial 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.

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer (NSCLC) who have already tried certain therapies without success. They should have had no more than two prior treatments, be in relatively good health with a life expectancy of at least 3 months, and agree to use contraception. Those with specific infections, severe liver issues, or active autoimmune diseases cannot join.Check my eligibility

What is being tested?

The study compares three treatment combinations for NSCLC: Cobolimab + Dostarlimab + Docetaxel; Dostarlimab + Docetaxel; and Docetaxel alone. It aims to find out if adding Cobolimab improves outcomes for patients whose cancer progressed after previous treatments.See study design

What are the potential side effects?

Possible side effects include immune-related reactions that can affect organs, infusion-related symptoms like fever or chills, fatigue, nerve damage in hands and feet (neuropathy), blood disorders such as low white cell counts increasing infection risk.

COSTAR Lung Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've had up to 2 treatments for my advanced cancer, including platinum chemotherapy and anti-PD-1/PD-L1 therapy.

Select...

My cancer can be measured by tests.

Select...

My cancer has worsened after treatment with platinum chemotherapy and anti-PD-(L)1 therapy.

Select...

I am fully active or can carry out light work.

Select...

My lung cancer is advanced or has spread, and it's either squamous or non-squamous.

Select...

I agree to provide a tissue sample from my cancer that was collected after it spread.

COSTAR Lung Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 44 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 44 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 44 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

OS in participants receiving dostarlimab + docetaxel relative to participants receiving docetaxel alone

Overall survival (OS) in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving docetaxel alone

Secondary outcome measures

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

Duration of response (DOR)

+13 more

COSTAR Lung Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Participants receiving dostarlimab+docetaxelExperimental Treatment2 Interventions

Group II: Participants receiving cobolimab+dostarlimab+docetaxelExperimental Treatment3 Interventions

Group III: Participants receiving docetaxelActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cobolimab

2016

Completed Phase 1

~830

Dostarlimab

2020

Completed Phase 2

~1000

Docetaxel

1995

Completed Phase 4

~5620

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,750 Previous Clinical Trials

8,066,694 Total Patients Enrolled

GSK Clinical TrialsStudy DirectorGlaxoSmithKline

3,595 Previous Clinical Trials

6,143,172 Total Patients Enrolled

Media Library

Non-Small Cell Lung Cancer Clinical Trial 2023: Cobolimab Highlights & Side Effects. Trial Name: NCT04655976 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What else is known about Cobolimab from other research?

"There are a total of 372 ongoing clinical trials for the medication Cobolimab with 136 of those trials in Phase 3. Although a majority of the research is being done in Fuzhou, Fujian, there are 23754 locations worldwide where Cobolimab is being studied."

Answered by AI

Does this clinical trial have a wide reach in Canada?

"Currently, this clinical trial is running at 18 sites. A few of these locations are Iowa City, Mineola and Las Vegas. It would be most convenient for you to select a trial site nearest to your location to minimize travel."

Answered by AI

For what ailments is Cobolimab most commonly prescribed?

"Cobolimab is a medication that is most often used to treat cancer. However, it can also be used to slow the progression of sarcoma or as part of platinum-containing chemotherapy for other diseases."

Answered by AI

Are we currently enrolling participants for this experiment?

"That is correct. The clinical trial is currently looking for participants. The trial was initially posted on 2020-12-08 and was last updated on 2022-04-12. The study is enrolling 250 participants at 18 locations."

Answered by AI

How many people are involved in this trial?

"Yes, the trial is currently recruiting patients, according to the information on clinicaltrials.gov. This particular trial was posted on 2020-12-08 and last updated on 2022-04-12. They are hoping to enroll 250 patients from 18 different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-Small Cell Lung Cancer Who Have Progressed on Prior Anti- Programmed Death-ligand 1 (PD-[L]1) Therapy and Chemotherapy

2020. "Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-Small Cell Lung Cancer Who Have Progressed on Prior Anti- Programmed Death-ligand 1 (PD-[L]1) Therapy and Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04655976.

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