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

Withdrawn before enrolling · Phase 1

Conditions studied: Squamous NSCLC

In brief

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.

Key facts

Study ID

NCT07073183

Run by

CureVac

People needed

0

Starts

2025-07-30

Expected to finish

2029-12-31

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Dose Escalation Part (Metastatic 1L Maintenance sqNSCLC)
• Patients with histologically confirmed metastatic Stage IV (per American Joint Commission on Cancer (AJCC) Staging Manual, Eighth Edition) sqNSCLC not amenable for surgical or locoregional therapy.
• Patients who have received pembrolizumab for 3 months but no longer than 6 months from start of pembrolizumab treatment (at least 3 cycles with a total dose of 600 mg), either as monotherapy or in combination with at least 2 cycles of chemotherapy with carboplatin and (nab-)paclitaxel as first-line treatment with no documented disease progression and who are indicated for maintenance therapy with pembrolizumab.
• Patients able to tolerate further anti-PD-1 therapy i.e., no criteria for permanent discontinuation of pembrolizumab due to toxicity have been met during previous treatment.
• No known targetable molecular aberration.
• Patients having measurable disease according to RECIST 1.1.
• Dose Expansion Part (Metastatic 1L sqNSCLC)
• Patients with histologically confirmed metastatic sqNSCLC (AJCC Staging Manual, Eighth Edition) not amenable for surgical or locoregional therapy and being eligible for first-line treatment with pembrolizumab and chemotherapy with carboplatin and paclitaxel. Patients should not have received any prior systemic treatment for metastatic disease. Previous (neo-)adjuvant treatment is allowed if there are at least 12 months between end of this treatment and development of metastatic disease.
• Inclusion Criteria applying to both Parts
• Available formalin-fixed paraffin-embedded (FFPE) tumor tissue samples from non- irradiated lesions that are not older than 6 months for retrospective assessment of antigen expression and potential other biomarker analyses (in total 15 slides of at least 5 μm thickness or equivalent amount provided as a single block).
• Recovered from all AEs related to prior therapies including anti-PD-(L)1 inhibitor treatment-related AEs to CTCAE Grade ≤ 1 or baseline (except for alopecia areata, vitiligo, chemotherapy induced polyneuropathy or endocrinopathies that are compensated by hormone replacement and Grade 2 lymphopenia).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Age ≥ 18 years on date of signing informed consent form (ICF).
• Each patient must voluntarily sign and date an ICF approved by an Independent Ethics Committee (IEC), prior to the initiation of any, screening or trial-specific procedures.
• Life expectancy ≥ 6 months.
• Females who are post-menopausal (no menses for at least 12 months before the Screening Visit), or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
• Females of childbearing potential must:
• Have a negative serum pregnancy test (hCG) with a sensitivity of at least 25 mIU/mL within 10 to 14 days, and within 24 hours prior to starting the trial treatment a negative urine pregnancy test if serum pregnancy test not done within 24 hours prior to starting the trial treatment.
• Agree to ongoing pregnancy testing during the trial.
• Use effective contraception at least 28 days before starting trial treatment through 30 days after the last dose of trial treatment. Effective methods of birth control include:
• Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
• oral
• intravaginal
• transdermal
• Progestogen-only hormonal contraception associated with inhibition of ovulation:

You may not qualify if…

• Disease progression on or within 12 months after the last dose of (neo-)adjuvant anti PD-(L)1 treatment before start of first-line treatment.
• Prior radiotherapy within 2 weeks before start of trial treatment.
• History of other malignancies unless the patient has undergone potentially curative treatment without evidence of recurrence within the last 3 years. Exception is BCC or carcinoma in situ of any site that has been adequately treated (with the exception of systemic therapy).
• Previous anaphylactic or severe allergic reaction to LNP-formulated drug or (mRNA) vaccine (or known allergy to any other component of CVHNLC).
• Allergy to aminoglycoside or beta-lactam antibiotics.
• History of previous permanent discontinuation of anti-PD-(L)1 therapy due to toxicity or any other contraindications to treatment with pembrolizumab, including severe hypersensitivity to anti-PD-1 checkpoint inhibitors, its active substance, or one of its excipients.
• Abnormal (≥ Grade 2 NCI-CTCAE v5.0) laboratory values as follows:
• Hemoglobin < 10 g/dL (6.2 mmol/L).
• White blood cell (WBC) count decrease < 2.5 ×109/L.
• Absolute neutrophil count (ANC) decrease < 1.5 ×109/L.
• Absolute lymphocyte count (ALC) decrease < 0.5 ×109/L.
• Platelet count decrease < 75 ×109/L.
• Bilirubin > 1.5 × upper limit of normal (ULN according to the performing lab's reference range), except for patients with Gilbert's syndrome.
• Alanine aminotransferase (ALT) > 3 × ULN (or ≤ 5 in patients with liver metastasis).
• Aspartate aminotransferase (AST) > 3 × ULN. (or ≤ 5 in patients with liver metastasis).
• Serum creatinine increased > 1.5 × ULN or creatinine clearance < 50 mL/min.
• Serum Albumin < 30 g/L.
• Received steroid treatment with doses exceeding 10 mg prednisolone or equivalent per day within 3 days prior to enrollment and/or requiring continued treatment with steroid doses above 10 mg/day prednisolone or equivalent or any other systemic immunosuppressive treatment within 28 days prior to enrollment or requiring chronic immunosuppression with such treatment. Inhalation steroids or topical steroids are allowed.
• Active infections requiring antibiotic treatment, associated with fever > 38°C or expected to potentially result in severe disease.
• Patients with known active hepatitis B (presence of HBsAg) or hepatitis C (presence of Hep C Ab) at screening or within 3 months prior to first trial treatment. In case of positive Hep C Ab, subjects may be enrolled in case of a negative confirmatory hepatitis C virus (HCV) RNA polymerase chain reaction (PCR) test.
• Patients with seropositivity of human immunodeficiency virus (HIV).
• Active autoimmune diseases (except for vitiligo or autoimmune thyroid disease that is stable under treatment), requiring treatment with steroids, disease modifying agents or immunosuppressants.
• Brain metastases or evidence of leptomeningeal tumor spread (with exception of stable brain metastases controlled by radiotherapy or other treatment without need for steroid treatment).
• Immunosuppression other than related to prior treatment of malignancy (i.e., platinum-based chemotherapy).
• Previous hematopoietic stem cell or solid organ transplantation.

Where it is running

• Virginia Cancer Center — Fairfax, Virginia, United States
• Virginia Commonwealth University, Massey Comprehensive Cancer Center, McGlothlin Medical Education Center — Richmond, Virginia, United States
• AP-HM - Hôpital Nord — Marseille, France
• Institut Curie - Hôpital de Paris — Paris, France
• CHU de Rennes - Hôpital Pontchaillou — Rennes, France
• Institut de Cancerologie de l'Ouest - Hôpital Saint Herblain - PPDS — Saint-Herblain, France
• Institut Claudius Regaud - PPDS — Toulouse, France
• Gustave Roussy — Villejuif, France
• Hospital Quironsalud Barcelona -NEXT Oncology — Barcelona, Spain, Spain
• Hospital Universitari Vall d´Hebron -Instituto de Investigacion Oncologica Vall dHebron (VHIO) — Barcelona, Spain, Spain
• Hospital Universitario Fundacion Jimenez Diaz - START MADRID — Madrid, Spain, Spain
• Hospital Universitario HM Sanchinarro - CIOCC - START MADRID — Madrid, Spain, Spain
• Hospital Regional Universitario Virgen de la Victoria — Málaga, Spain, Spain

Full record on ClinicalTrials.gov

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