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Monoclonal Antibodies

V940 + Pembrolizumab for Non-Small Cell Lung Cancer

Phase 3

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

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

Must have

* Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) \[American Joint Committee on Cancer (AJCC) 8th Edition\]

* Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations \[eg, DEL19 or L858R\])

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~129 months

Awards & highlights

Pivotal Trial

Summary

"This trial aims to see if giving V940 and pembrolizumab after surgery can help prevent cancer from returning in people with non-small cell lung cancer, compared to those who receive a placebo and

Who is the study for?

This trial is for adults with resectable Stage II-III non-small cell lung cancer (NSCLC) who haven't had prior treatments and whose tumors didn't fully respond to initial therapy before surgery. They must be in good physical condition, not need EGFR-targeted primary therapy, and can have controlled hepatitis B or C or HIV.

What is being tested?

The study tests if V940 combined with pembrolizumab extends the time patients remain cancer-free post-surgery compared to a placebo plus pembrolizumab. It's for NSCLC patients whose cancer persisted after neoadjuvant treatment and surgery.

What are the potential side effects?

Possible side effects include immune system reactions, infusion-related symptoms, fatigue, nausea from chemotherapy drugs like Gemcitabine and Pemetrexed, allergic responses to Paclitaxel, organ damage from Carboplatin or Cisplatin.

Eligibility Criteria

Inclusion Criteria

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

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I have a confirmed diagnosis of early-stage lung cancer that can be surgically removed.

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My cancer does not have EGFR mutations, so I don't need EGFR-targeted therapy.

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My cancer did not fully respond to initial treatment with chemotherapy and pembrolizumab before surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~129 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~129 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~129 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Disease-Free Survival (DFS)

Secondary study objectives

Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5)

Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7)

Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30)

+6 more

Awards & Highlights

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pembrolizumab + V940Experimental Treatment7 Interventions

For neoadjuvant treatment, participants will receive pembrolizumab 200 mg via intravenous (IV) infusion every 3-week cycle for up to 4 cycles PLUS background chemotherapy via IV infusion (cisplatin 75 mg/m\^2 or carboplatin area under the curve \[AUC\] 5 or 6 mg/mL/min, pemetrexed 500 mg/m\^2, gemcitabine 1000 mg/m\^2, paclitaxel 175 mg/m\^2 or 200 mg/m\^2 given at a dose and combination per investigator's choice) every 3-week cycle for up to 4 cycles (total neoadjuvant treatment duration of up to \~12 weeks). After surgical resection, for adjuvant treatment, participants will receive pembrolizumab 400 mg via IV infusion every 6-week cycle for up to 7 cycles PLUS V940 1 mg via intramuscular (IM) injection every 3 weeks for up to 9 doses (total adjuvant treatment duration of up to \~42 weeks).

Group II: Pembrolizumab + PlaceboActive Control7 Interventions

For neoadjuvant treatment, participants will receive pembrolizumab 200 mg via IV infusion every 3-week cycle for up to 4 cycles PLUS background chemotherapy via IV infusion (cisplatin 75 mg/m\^2 or carboplatin AUC 5 or 6 mg/mL/min, pemetrexed 500 mg/m\^2, gemcitabine 1000 mg/m\^2, paclitaxel 175 mg/m\^2 or 200 mg/m\^2 given at a dose and combination per investigator's choice) every 3-week cycle for up to 4 cycles (total neoadjuvant treatment duration of up to \~12 weeks). After surgical resection, for adjuvant treatment, participants will receive pembrolizumab 400 mg via IV infusion every 6-week cycle for up to 7 cycles PLUS matching placebo via IM injection every 3 weeks for up to 9 doses (total adjuvant treatment duration of up to \~42 weeks).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pemetrexed

2014

Completed Phase 3

~5550

Paclitaxel

2011

Completed Phase 4

~5450