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Safety and Tolerability of CVHNLC Plus Pembrolizumab in Patients With Squamous Non Small-Cell Lung Cancer (sqNSCLC)

NCT07073183 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-07-18

No results posted yet for this study

Summary

This is an open-label, first-in-human, dose escalation study of CV09070101 mRNA (CVHNLC) in patients with metastatic Squamous Non-Small-Cell Lung Cancer (sqNSCLC).

The study will evaluate the safety and tolerability of CVHNLC plus pembrolizumab in an Dose Escalation Part and, once the safety of this combination is established, CVHNLC plus prembrolizumab and chemotherapy (carboplatin and paclitaxel) will be evaluated in an Dose Expansion Part with the recommended dose selected from the Dose Escalation Part.

Conditions

  • Squamous NSCLC

Interventions

BIOLOGICAL

CV09070101 mRNA vaccine (CVHNLC) 50 µg

CVHNLC will be administered as in IM injection (4x in induction treatment period, than during main treatment period every 3 weeks) plus pembrolizumab (3-weekly)

BIOLOGICAL

CV09070101 mRNA vaccine (CVHNLC) 100 µg

CVHNLC will be administered as in IM injection (4x in induction treatment period, than during main treatment period every 3 weeks) plus pembrolizumab (3-weekly)

BIOLOGICAL

CV09070101 mRNA vaccine (CVHNLC) 200 µg

CVHNLC will be administered as in IM injection (4x in induction treatment period, than during main treatment period every 3 weeks) plus pembrolizumab (3-weekly)

BIOLOGICAL

CV09070101 mRNA vaccine (CVHNLC) 400 µg

CVHNLC will be administered as in IM injection (4x in induction treatment period, than during main treatment period every 3 weeks) plus pembrolizumab (3-weekly)

BIOLOGICAL

CV09070101 mRNA vaccine (CVHNLC) 400 µg

CVHNLC will be administered as in IM injection (4x in induction treatment period, than during main treatment period every 3 weeks) plus pembrolizumab (3-weekly) and carboplatin/paclitaxel (3-weekly)

Sponsors & Collaborators

  • CureVac

    lead INDUSTRY

Principal Investigators

  • Clinical Trial Information · CureVac SE

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-30
Primary Completion
2029-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States
  • France
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07073183 on ClinicalTrials.gov