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Active, not recruiting Phase 2

A Study to Evaluate Two Dosing Regimens of Subcutaneous Nivolumab in Combination With Intravenous Ipilimumab and Chemotherapy in Participants With Previously Untreated Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC)

NCT06946797 · tracked via the Priya Life Science Italy tracker
Phase
Phase 2
Started
2025-09-19
Last updated
2026-05-14

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Nivolumab →Ipilimumab →Carboplatin →Paclitaxel →Pemetrexed →Cisplatin →

Nivolumab: Specified dose on specified days

Ipilimumab: Specified dose on specified days

Carboplatin: Specified dose on specified days

Paclitaxel: Specified dose on specified days

Pemetrexed: Specified dose on specified days

Cisplatin: Specified dose on specified days

Study summary

The purpose of this study is to evaluate two dosing regimens of subcutaneous Nivolumab in combination with intravenous Ipilimumab and chemotherapy in participants with previously untreated metastatic or recurrent Non-Small Cell Lung Cancer (NSCLC)

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria * Participants must have histologically confirmed stage IV or recurrent non-small cell lung cancer (NSCLC) (as defined by the 9th edition of the IASLC Lung Cancer Staging Guidelines) of squamous or non-squamous histology. * Participants must have no prior systemic anti-cancer treatment (including EGFR, ALK, ROS-1, BRAF, RET, and NTRK inhibitors) given as primary therapy for advanced or metastatic disease. * Participants with prior definitive chemoradiation for locally advanced disease is permitted as long as the last administration of chemotherapy or radiotherapy (whichever was given last) occurred at least 6 months prior to randomization. Participants with locally advanced disease with recurrence after chemoradiation therapy (stage III disease, specifically refers to patients with no curative options) are eligible to enroll. * Participants with prior adjuvant or neoadjuvant chemotherapy for early-stage lung cancer are permitted if completed at least 6 months prior to randomization. * Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 at screening and confirmed prior to randomization. * Participants must have measurable disease by CT or MRI per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria with radiographic tumor assessment performed within 28 days of randomization. Exclusion Criteria * Participants must not have any prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. * Participants must not have any known driver mutations with available targeted therapy (including but not limited to EGFR mutations, ALK translocations, ROS-1 translocations and known BRAFV600E, that are sensitive to available targeted inhibitor therapy; participants with a known activating RET mutations and NTRK fusion gene alterations). * Participants must not have any untreated central nervous system (CNS) metastases * Participants must not have leptomeningeal metastases (carcinomatous meningitis). * Participants must not have any active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. * Participants with previous malignancies (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to randomization and no additional therapy is required or anticipated to be required during the study period. * Participants must not have a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. * Participants must not have any history of interstitial lung disease or pneumonitis that required oral or IV glucocorticoids to assist with management. * Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

  • Maximum observed serum concentration (Cmax) of subcutaneous Nivolumab in serum — Up to 3 weeks
  • Time to peak concentration (Tmax) of subcutaneous Nivolumab in serum — Up to 3 weeks
  • Area under the concentration-time curve within a dosing interval (AUC(TAU)) of subcutaneous Nivolumab in serum — Up to 3 weeks
  • Concentration at the end of a dosing interval (Ctau) of subcutaneous Nivolumab in serum — Up to 3 weeks
  • Trough observed concentration (Ctrough) of subcutaneous Nivolumab — At Cycle 7 Day 1 (Week 18)

Trial sites (38)

FacilityCityRegionStatus
Local Institution - 0032 Anchorage Alaska
Local Institution - 0062 Los Angeles California
Local Institution - 0063 Boise Idaho
Local Institution - 0052 Boise Idaho
Local Institution - 0064 Post Falls Idaho
Local Institution - 0047 Cleveland Ohio
Local Institution - 0033 Cleveland Ohio
Local Institution - 0051 Allentown Pennsylvania
Local Institution - 0041 Brasília Federal District
Local Institution - 0043 Belo Horizonte Minas Gerais
Local Institution - 0038 Porto Alegre Rio Grande do Sul
Local Institution - 0037 Barretos São Paulo
Local Institution - 0034 São Paulo Brazil
Local Institution - 0067 Santiago Santiago Metropolitan
Local Institution - 0065 Dijon Côte-d'Or
Local Institution - 0003 Suresnes Hauts-de-Seine
Local Institution - 0010 Paris Île-de-France Region
Local Institution - 0012 Athens Attikí
Local Institution - 0013 Chaïdári Attikí
Local Institution - 0011 Thessaloniki Kentrikí Makedonía
Local Institution - 0014 Larissa Thessalía
Local Institution - 0015 Meldola Emilia-Romagna
Local Institution - 0057 Udine Friuli Venezia Giulia
Local Institution - 0020 Bergamo Lombardy
Local Institution - 0019 Florence Tuscany
Local Institution - 0017 Novara Italy
Local Institution - 0081 Warsaw Masovian Voivodeship
Local Institution - 0080 Prabuty Pomeranian Voivodeship
Local Institution - 0079 Lodz Łódź Voivodeship
Local Institution - 0073 Bucharest Bucharest
Local Institution - 0076 Florești Cluj
Local Institution - 0077 Craiova Dolj
Local Institution - 0075 Bucharest Romania
Local Institution - 0074 Cluj-Napoca Romania
Local Institution - 0078 Iași Romania
Local Institution - 0031 Soweto Gauteng
Local Institution - 0009 Sandton GP
Local Institution - 0084 Rondebosch Western Cape
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06946797 on ClinicalTrials.gov ↗ ← All trials in Italy