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Alkylating agents

Pembrolizumab + Chemotherapy for Non-Small Cell Lung Cancer

Phase 2

Waitlist Available

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

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

Must have

No planned radiation or other cancer treatment in the 3 months following registration

Histologic or cytologic diagnosis of non-small cell lung cancer (adenocarcinoma). Stage IV or recurrent metastatic non-small cell lung cancer. No planned initiation of definitive (potentially curative) concurrent chemo-radiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing pembrolizumab with or without chemotherapy to treat patients with stage IV non-small cell lung cancer that has come back and spread to other places in the body.

Who is the study for?

This trial is for patients aged 70 or older with advanced non-small cell lung cancer that has returned and spread. Participants must have proper organ function, no untreated brain metastases, be off corticosteroids, speak English to complete questionnaires, and not plan other cancer treatments within 3 months of joining.

What is being tested?

The study tests pembrolizumab (an immunotherapy drug) alone or combined with chemotherapy drugs pemetrexed and carboplatin in elderly patients. It aims to see if these treatments can shrink tumors by helping the immune system attack the cancer or by stopping tumor growth.

What are the potential side effects?

Pembrolizumab may cause immune-related side effects like inflammation in organs, fatigue, skin reactions, and changes in hormone levels. Chemotherapy can lead to nausea, hair loss, low blood cell counts increasing infection risk, tiredness, and possible kidney issues.

Eligibility Criteria

Inclusion Criteria

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

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I have no cancer treatments planned for the next 3 months.

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My lung cancer is advanced or has returned, and I'm not planning on undergoing a treatment aimed at curing it.

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I do not have an autoimmune disorder, haven't had an organ transplant, and am not on immunosuppressants.

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I don't have untreated brain cancer and am not on steroids.

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I am starting pembrolizumab treatment soon, as recommended by my doctor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Incidence of grade 3 or worse adverse events post registration

Secondary study objectives

Comprehensive geriatric assessment risk score

Overall survival (OS)

Quality of life (QOL): Linear Analogue Self-Assessment [LASA] questionnaire

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

Group I: Group B (pembrolizumab, pemetrexed, carboplatin)Experimental Treatment6 Interventions

Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group II: Group A (pembrolizumab)Experimental Treatment4 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pemetrexed

2014

Completed Phase 3

~5550

Pembrolizumab

2017

Completed Phase 3

~3150