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NCT07073183

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

Not yet recruiting Phase 1 Last updated 18 July 2025
What this trial tests

Phase 1 trial testing CV09070101 mRNA vaccine (CVHNLC) 50 µg in Squamous NSCLC in 36 participants. Not yet recruiting.

Timeline
30 July 2025
Primary endpoint
31 December 2029
31 December 2029

Quick facts

Lead sponsorCureVac
PhasePhase 1
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment36
Start date30 July 2025
Primary completion31 December 2029
Estimated completion31 December 2029
Sites13 locations across France, United States, Spain

Drugs / interventions tested

Conditions studied

Sponsor

CureVac — full company profile →

Who can join

18 and older, any sex, with Squamous NSCLC. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Advancing Lung Cancer Treatment: mRNA Therapeutics and Delivery Strategies.
    Yaremenko AV, Pechnikova NA, Liu C. · · 2025 · cited 1× · PMID 41124104 · DOI 10.1021/acs.nanolett.5c03826
  2. Emerging Immunotherapy and Antibody-Derived Therapeutics for the Treatment of Advanced Non-Small-Cell Lung Cancer: A Review.
    Hou AY, Elantably D, Manochakian R, Velcheti V, et al · · 2026 · PMID 42073614 · DOI 10.3390/cancers18081291
  3. Nanovaccines for lung cancer: Platforms, mechanistic insights, and translational challenges
    Hosseinalizadeh H, Ge F, Davari M, Liu X, et al · · 2026
  4. Directions of Immunotherapy for Non-Small-Cell Lung Cancer Treatment: Past, Present and Possible Future.
    Leone GM, Scuderi G, Fagone P, Mangano K. · · 2025 · PMID 41303538 · DOI 10.3390/ijms262211055

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Other CureVac trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07073183.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing