Phase 3 study of adjuvant V940 and Pembrolizumab in resected Stage II, IIIA, IIIB NSCLC

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

4 Apr 2024 → ongoing

Decision date (initial)

2024-03-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Moderna · Merck Sharp & Dohme LLC

External identifiers

EU CT number

2023-504923-20-00

WHO UTN

U1111-1290-3969

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Pharmacogenetic, Efficacy, Pharmacokinetic, Pharmacogenomic

To compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to DFS

Secondary objectives 5

1. To compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to OS.
2. To evaluate V940 plus pembrolizumab to placebo plus pembrolizumab with respect to DMFS as assessed by the investigator.
3. To evaluate V940 plus pembrolizumab to placebo plus pembrolizumab with respect to LCSS.
4. To evaluate V940 plus pembrolizumab to placebo plus pembrolizumab with respect to mean change from baseline in global health status/QoL, physical functioning, and role functioning using the EORTC QLQ-C30 and EORTC QLQ-LC24.
5. To evaluate the safety and tolerability of V940 plus pembrolizumab.

Conditions and MedDRA coding

Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Has undergone margin negative, completely resected non–small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (with nodal involvement [N2]) squamous or nonsquamous tumor, node, metastasis (TNM) staging per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.
2. Has no evidence of disease before randomization.
3. Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy.
4. No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab.
5. Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
6. Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
7. Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).

Exclusion criteria 13

1. Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large cell components or a sarcomatoid carcinoma.
2. HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.
3. Received prior neoadjuvant therapy for their current NSCLC diagnosis.
4. Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis.
5. Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
6. Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
7. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
8. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
9. Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication.
10. Known additional malignancy that is progressing or has required active treatment within the past 5 years.
11. Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.
12. History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
13. Active infection requiring systemic therapy.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Disease-Free Survival (DFS)

Secondary endpoints 11

1. Overall Survival (OS)
2. Distant Metastasis-Free Survival (DMFS)
3. Lung Cancer Specific Survival (LCSS)
4. 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) Combined Score
5. Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
6. Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30
7. Change from Baseline in the EORTC QLQ-C30 Dyspnea (Item 8) Score on the EORTC QLQ-C30
8. Change from Baseline in the EORTC QLQ-Lung Cancer Questionnaire (LC24) Coughing (Items 31 and 52) Combined Score on the EORTC QLQ-LC24
9. Change from Baseline in the EORTC QLQ-LC24 Chest Pain (Item 40) Score on the EORTC QLQ-LC24
10. Number of Participants Who Experience an Adverse Event (AE)
11. Number of Participants Who Discontinue Study Treatment Due to an AE

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Nazly Shariati

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Nazly Shariati

Third parties 6

Locations

18 EU/EEA countries · 79 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 225 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications