NIVOLUMAB for Non-small cell lung cancer (metastatic) | Non-small cell lung cancer (recurrent)

Inclusion criteria

• {"criterion_text":"- Females and males ≥18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at time of ICF signature."}
• {"criterion_text":"- Histologically confirmed stage IV or recurrent NSCLC (as defined by the 9th edition of the IASLC Lung Cancer Staging Guidelines) of squamous or non-squamous histology."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Prior adjuvant or neoadjuvant chemotherapy for early-stage lung cancer is permitted if completed at least 6 months prior to randomization."}
• {"criterion_text":"- ECOG Performance Status ≤ 1 at screening and confirmed prior to randomization."}
• {"criterion_text":"- Measurable disease by CT or MRI per RECIST 1.1 criteria with radiographic tumor assessment performed within 28 days of randomization."}

Exclusion criteria

• {"criterion_text":"- 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 costimulation or checkpoint pathways."}
• {"criterion_text":"- 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). - Positive, unknown, or indeterminate EGFR mutation status in participants of non-squamous histology are excluded."}
• {"criterion_text":"- Participants with untreated CNS metastases are excluded. - Participants are eligible if CNS metastases are asymptomatic and do not require immediate treatment or have been treated and participants have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment)."}
• {"criterion_text":"- Participants with leptomeningeal metastases (carcinomatous meningitis)."}
• {"criterion_text":"- Participants with 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Participants with 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."}
• {"criterion_text":"- Participants who have history of interstitial lung disease or pneumonitis that required oral or IV glucocorticoids to assist with management."}

Primary endpoints

• {"endpoint_text":"- Measuring various PK parameters of nivolumab SC in the blood during the first treatment cycle.","definition_or_measurement_approach":"Pharmacokinetic (PK) parameters measured in blood samples taken during the first treatment cycle (timing and specific PK parameters not further specified in the provided record)."}
• {"endpoint_text":"- Measuring the amount of nivolumab SC left in the body just before the next dose is given on the first day of the seventh treatment cycle.","definition_or_measurement_approach":"Trough concentration measurement: quantification of nivolumab SC in blood immediately prior to dosing on Day 1 of Cycle 7."}

Secondary endpoints

• {"endpoint_text":"- Recording the incidence of side effects (adverse events or AEs), serious adverse events (SAEs), drug-related AEs, immune-mediated AEs (IMAEs), specific AEs, AEs leading to discontinuation, and deaths until 100 days post end of treatment.","definition_or_measurement_approach":"Safety monitoring and AE reporting through end of treatment plus 100-day post-treatment follow-up; recording incidence and classifications of AEs, SAEs, drug-related AEs, IMAEs, AEs leading to discontinuation, and deaths."}
• {"endpoint_text":"- Measuring the incidence of antibodies against nivolumab SC and ipilimumab IV, including neutralizing antibodies if applicable, until 100 days post end of treatment.","definition_or_measurement_approach":"Immunogenicity testing for anti-drug antibodies (including neutralizing antibodies if applicable) up to 100 days after end of treatment."}
• {"endpoint_text":"- Evaluating the PK parameters of ipilimumab IV in the blood when given with nivolumab SC and chemotherapy during the first treatment cycle.","definition_or_measurement_approach":"Pharmacokinetic (PK) assessment of ipilimumab IV in blood samples collected during the first treatment cycle when administered in combination with nivolumab SC and chemotherapy."}

Romania

Earliest CTIS Part Ii Submission Date

14-05-2025

Latest Decision Or Authorization Date

09-03-2026

Processing Time Days

299

Number Of Sites

7

Number Of Participants

12

Italy

Earliest CTIS Part Ii Submission Date

25-07-2025

Latest Decision Or Authorization Date

09-03-2026

Processing Time Days

227

Number Of Sites

6

Number Of Participants

9

Poland

Earliest CTIS Part Ii Submission Date

22-07-2025

Latest Decision Or Authorization Date

03-02-2026

Processing Time Days

196

Number Of Sites

3

Number Of Participants

6

France

Earliest CTIS Part Ii Submission Date

29-07-2025

Latest Decision Or Authorization Date

10-03-2026

Processing Time Days

224

Number Of Sites

3

Number Of Participants

5

Greece

Earliest CTIS Part Ii Submission Date

25-07-2025

Latest Decision Or Authorization Date

11-03-2026

Processing Time Days

229

Number Of Sites

4

Number Of Participants

8

Primary sponsor

Full Name

Bristol-Myers Squibb Services Unlimited Company

Organisation Type

Pharmaceutical company

Country Of Registered Address

Ireland

Contract research organisations

Name

Iqvia Inc.

Responsibilities

Site payments

Name

Perceptive Informatics Inc.

Responsibilities

Medical image analysis/ review - X-ray, MRI, ultrasound.

Name

Medidata Solutions Inc.

Responsibilities

Data Management Platform

Name

PPD Global Central Labs

Responsibilities

Sample management for central testing

Name

Greenphire LLC

Responsibilities

Provides electronic payments, travel arrangements,electronic study-related comunications to patients

Name

Labcorp Central Laboratory Services LP

Responsibilities

Testing of ADA samples

Name

Clinical Trial Media Inc.

Responsibilities

Patient recruitment materials

Name

Transperfect Translations International Inc.

Responsibilities

Translation Services

Third parties

• {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Site payments","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound.","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Data Management Platform","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Translation Services","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Provides electronic payments, travel arrangements,electronic study-related comunications to patients","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Testing of ADA samples","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Sample management for central testing","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"Patient recruitment materials","organisation_type":"Pharmaceutical company"}