Pembrolizumab SC vs IV for Lung Cancer

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme LLC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing a new way to give the cancer drug pembrolizumab as an injection under the skin for people with advanced lung cancer. The goal is to see if this method works as well as the traditional IV method. The study will also check if it is safe and effective when used with standard chemotherapy.

Eligibility Criteria

This trial is for adults with Stage IV squamous or nonsquamous NSCLC who haven't had systemic treatment for metastatic disease. They must have good organ function, an ECOG score of 0 or 1, and agree to use contraception. Exclusions include severe drug hypersensitivity, recent investigational drug use, certain psychiatric disorders, active infections requiring therapy, specific lung conditions like pneumonitis, other active cancers within the last 3 years, known brain metastases unless treated under certain conditions, HIV/Hepatitis B/C infections.

Inclusion Criteria

I am fully active or can carry out light work.

I have been diagnosed with non-small cell lung cancer.

My lung cancer is at stage IV.

Exclusion Criteria

I have been treated for an autoimmune disease in the last 2 years.

I have or had lung inflammation that needed steroids.

I am currently being treated for an infection.

I have a history of HIV, Hepatitis B, or active Hepatitis C.

I have received an organ or tissue transplant from another person.

I will not need any cancer treatment other than the study's while participating.

Treatment Details

The study tests pembrolizumab administered subcutaneously versus intravenously in combination with standard chemotherapy (Paclitaxel/Nab-Paclitaxel/Carboplatin/Cisplatin/Pemetrexed) as first-line treatment for metastatic NSCLC. It aims to compare the safety and effectiveness between the two methods of pembrolizumab administration.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A: Pembrolizumab SC + Platinum Doublet ChemotherapyExperimental Treatment6 Interventions

Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.

Group II: Arm B: Pembrolizumab IV + Platinum Doublet ChemotherapyActive Control6 Interventions

Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Paraplatin for: