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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

Must not have

Participant has preexisting peripheral neuropathy that is Grade >=2 by NCI CTCAE v5.0 criteria

Participant has received prior systemic therapy for the treatment of metastatic NSCLC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 59 month

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have moderate to severe nerve damage in my hands or feet.

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I have had treatment for my lung cancer that has spread.

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I've had lung radiation over 30 Gray in the last 6 months.

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I have taken steroids or immunosuppressive medication in the last 3 days.

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I have active brain or spinal cord cancer spread.

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I am HIV positive.

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I have or had lung inflammation that needed steroids for treatment.

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I have not received a live vaccine in the last 30 days.

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I cannot receive pemetrexed and platinum-based chemotherapy according to local guidelines.

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I have not had an infection needing treatment in the week before starting the study.

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I have active issues with my digestive system, like diverticulitis or blockages.

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I have fluid buildup in my abdomen or around my lungs.

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I have previously been treated with immunotherapy for cancer.

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My liver function is normal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 59 month

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate (ORR)

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~1760