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Monoclonal Antibodies

ABP 234 vs Keytruda for Lung Cancer

Phase 3

Recruiting

Research Sponsored by Amgen

Eligibility Criteria Checklist

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

Must have

At least 18 years of age.

Histologically or cytologically confirmed stage IV non-squamous Non-Small Cell Lung Cancer (NSCLC).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 49

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to compare how well ABP 234 works compared to the drug Keytruda in treating a specific condition.

Who is the study for?

This trial is for adults with stage IV non-squamous Non-Small Cell Lung Cancer (NSCLC) who haven't had systemic treatment for advanced disease. They should be relatively healthy, able to perform daily activities (ECOG score 0 or 1), and not have certain gene mutations (EGFR, ALK, ROS-1 negative). Participants must also have a life expectancy of at least 3 months and available tumor tissue for testing.

What is being tested?

The study aims to compare the effectiveness of ABP 234 with Keytruda® (pembrolizumab), which are both treatments for lung cancer. Patients will receive either ABP 234 or pembrolizumab to see how well they work in treating their cancer.

What are the potential side effects?

Possible side effects from ABP 234 and pembrolizumab may include immune system reactions that can affect organs, fatigue, skin issues, flu-like symptoms, digestive problems, and changes in blood tests. Each person's reaction to the medication can vary.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My lung cancer is advanced and not squamous type.

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I have not received any systemic treatment for my advanced disease.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My tumor tissue from surgery is available for testing.

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My cancer does not have mutations in EGFR, ALK, or ROS-1 genes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 49

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 49

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 49 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Objective response (OR)

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Pembrolizumab (US)Experimental Treatment1 Intervention

Part 1: Participants will receive FDA-licensed pembrolizumab followed by pemetrexed administered with platinum-based chemotherapy (cisplatin or carboplatin). Part 2: Participants will receive FDA-licensed pembrolizumab followed by pemetrexed.

Group II: Pembrolizumab (EU)Experimental Treatment1 Intervention

Part 1: Participants will receive EU-approved pembrolizumab followed by pemetrexed administered with platinum-based chemotherapy (cisplatin or carboplatin). Part 2: Participants will receive EU-approved pembrolizumab followed by pemetrexed.

Group III: ABP 234Experimental Treatment1 Intervention

Part 1: Participants will receive ABP 234 followed by pemetrexed administered with platinum-based chemotherapy (cisplatin or carboplatin). Part 2: Participants will receive ABP 234 followed by pemetrexed.

0 / 6Eligibility criteria met