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Alkylating agents

Immunotherapy + Chemotherapy for Lung Cancer

Phase 2
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have measurable disease, that is (i.e.) presenting with at least 1 measurable lesion per RECIST v1.1 as determined by the local site Investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions and if there are other target lesions. If there is only 1 target lesion that was previously irradiated, the participant is not eligible.
Participants must have measurable disease presenting with at least 1 measurable lesion per RECIST v1.1 as determined by the local site Investigator/radiology assessment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 59 month
Awards & highlights

Study Summary

This trial will compare the efficacy and safety of two immunotherapy drugs, dostarlimab and pembrolizumab, when used in combination with chemotherapy to treat non-squamous NSCLC.

Who is the study for?
Adults with advanced non-squamous NSCLC without certain mutations, who haven't had prior treatments for metastatic lung cancer. They should have a life expectancy of at least 3 months, measurable disease per RECIST v1.1, and good performance status (ECOG score of 0 or 1). Adequate organ function and no history of severe allergies to study drugs are required.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of two PD-1 inhibitors: Dostarlimab and Pembrolizumab, each combined with chemotherapy (pemetrexed, cisplatin/carboplatin), in treating non-squamous NSCLC. The goal is to see which combination works better for patients without specific genetic mutations.See study design
What are the potential side effects?
Potential side effects include immune-related reactions that can affect organs, infusion-related symptoms like chills or fever, fatigue, nausea or vomiting from chemotherapy, blood cell count changes increasing infection risk. Each patient may experience side effects differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have at least one tumor that can be measured and has not been previously treated with radiation unless it has shown growth.
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I have at least one tumor that can be measured.
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My cancer's PD L1 status is known, tested by the 22C3 pharmDx method.
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I have recovered from side effects of previous treatments.
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My cancer's PD-L1 status was tested with the 22C3 pharmDx assay.
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I am 18 or older, understand the study, and agree to participate.
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My organs are functioning well.
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My advanced lung cancer is non-squamous and lacks certain genetic mutations.
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I am fully active or can carry out light work.
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I am fully active or can carry out light work.
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My advanced lung cancer lacks certain genetic changes treatable by specific drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 59 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 59 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Number of Participants Received Concomitant Medications
Number of Participants With AEs Leading to Death
Number of Participants With Abnormal Eastern Cooperative Oncology Group (ECOG) Performance Status
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Participants receiving dostarlimab plus chemotherapyExperimental Treatment2 Interventions
Participants will receive dostarlimab on Day 1 of every 21 Day cycle followed by pemetrexed, and then followed by cisplatin or carboplatin (Cycles 1 to 4 only) as per investigator decision.
Group II: Participants receiving pembrolizumab plus chemotherapyActive Control2 Interventions
Participants will receive pembrolizumab on Day 1 of every 21 Day cycle followed by pemetrexed, and then followed by cisplatin or carboplatin (Cycles 1 to 4 only) as per investigator decision.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemotherapy
2003
Completed Phase 4
~3050
Dostarlimab
2020
Completed Phase 2
~1000

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,751 Previous Clinical Trials
8,067,229 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,687 Total Patients Enrolled

Media Library

Non-Small Cell Lung Cancer Research Study Groups: Participants receiving dostarlimab plus chemotherapy, Participants receiving pembrolizumab plus chemotherapy

Frequently Asked Questions

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

To what extent can this research accommodate participants?

"This research project is no longer recruiting participants. The trial was initially posted on November 19th 2020, with the last update being issued on June 26th 2022. If you are seeking alternative clinical trials, there are 2045 active studies for non-small cell lung carcinoma and 997 involving Dostarlimab enrolling patients currently."

Answered by AI

What ailments is Dostarlimab typically prescribed for?

"Dostarlimab is primarily used to treat malignant neoplasms, yet it may also be beneficial for managing unresectable melanoma, microsatellite instability high cases, and assisting in the treatment of cancer after chemotherapy."

Answered by AI

Is access to this trial available for individuals seeking treatment at the present time?

"Clinicaltrials.gov informs us that this particular medical trial is no longer actively recruiting patients, having been initially posted on November 19th 2020 and last updated on June 26th 2022. However, there are an extensive 3 thousand and forty-two other studies in search of volunteers presently."

Answered by AI

How many venues are facilitating this experiment?

"This medical investigation is open to participants at 7 different sites in Fairfax, Palm Bay and Pensacola. It is recommended that you select the closest clinic to your area of residence for convenience when enrolling."

Answered by AI

Could you expound upon any previous experiments regarding Dostarlimab?

"Studies investigating the efficacy of Dostarlimab are numerous, with 997 ongoing clinical trials. Of these active studies, 127 have reached Phase 3 and many can be found in Houston, Texas. Moreover, 36642 medical sites globally are conducting investigations for this medication."

Answered by AI

What safety measures have been taken to ensure the security of patients utilizing Dostarlimab?

"According to our risk assessment, Dostarlimab is considered a 2 on the safety scale due to limited clinical data suggesting its efficacy."

Answered by AI

Who else is applying?

What state do they live in?
South Carolina
Massachusetts
Minnesota
Other
How old are they?
65+
18 - 65
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Efficacy Comparison of Dostarlimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
2020. "Efficacy Comparison of Dostarlimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04581824.
All > Lung Cancer Dallas
~55 spots leftby Apr 2025
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