PUMITAMIG for Non-small cell lung cancer

Inclusion criteria

• {"criterion_text":"- Participants (male and female) ≥ 18 years of age must have confirmed diagnosis of advanced stage NSCLC with documented high levels (≥ 50%) of a protein called PD-L1\n- Participants must be in good overall health\n- Participants should have not received prior systemic anti-tumor therapy for advanced NSCLC"}

Exclusion criteria

• {"criterion_text":"- Participants must not have any documented gene changes in their cancer for which there are already approved treatments available\n- Participants must not have untreated brain metastases\n- significant cardiovascular disease\n- active autoimmune disease\n- serious lung disease\n- high risk of pulmonary bleeding\n- abdominal fistula or gastrointestinal perforation within 6 months prior to randomization"}

Primary endpoints

• {"endpoint_text":"- Progression-free survival (PFS) assessed by BICR, to see if pumitamig works better than pembrolizumab by evaluating how long it takes before the cancer starts growing again by radiographic imaging techniques","definition_or_measurement_approach":"Assessed by Blinded Independent Central Review (BICR) using radiographic imaging to measure time until disease progression (PFS)."}
• {"endpoint_text":"- Overall Survival (OS), to assess if people live longer when they take pumitamig compared to pembrolizumab","definition_or_measurement_approach":"Time from randomization to death from any cause (OS)."}

Secondary endpoints

• {"endpoint_text":"- overall response of pumitamig versus pembrolizumab","definition_or_measurement_approach":"Overall response (objective tumor response) comparing pumitamig versus pembrolizumab (as stated)."}
• {"endpoint_text":"- how safe each medicine is","definition_or_measurement_approach":"Safety assessments and adverse event monitoring to compare safety profiles of each medicine (as stated)."}
• {"endpoint_text":"- how well participants tolerate the medicines","definition_or_measurement_approach":"Tolerability assessments (as stated)."}

Portugal

Earliest CTIS Part Ii Submission Date

19-03-2026

Latest Decision Or Authorization Date

15-05-2026

Processing Time Days

57

Number Of Sites

2

Number Of Participants

6

Primary sponsor

Full Name

Bristol-Myers Squibb Services Unlimited Company

Organisation Type

Pharmaceutical company

Country Of Registered Address

Ireland

Contract research organisations

Name

Signant Health Global LLC

Responsibilities

Subject number assignment, Treatment /Arm assignment, Drug (re)supplies assignment, PRO/COA

Name

Medidata Solutions Inc.

Responsibilities

Sponsor duty code: 6

Name

Iqvia Inc.

Responsibilities

Regulatory, SUSAR reporting and other operational responsibilities

Name

Bioclinica Inc.

Responsibilities

Medical image analysis/ review - X-ray, MRI, ultrasound, Customer Care / Site Logistics / Training / Equipment Customization

Name

Labcorp Central Laboratory Services SARL

Responsibilities

Tumor blocks/slides storage, PGX and central lab services

Third parties

• {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"Subject number assignment, Treatment /Arm assignment, Drug (re)supplies assignment, PRO/COA","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Sponsor duty code: 6","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Germany","full_name":"Discovery Life Sciences Biomarker Services GmbH","duties_or_roles":"Samples as well as whole transcriptome sequencing","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"Development partner conducting performance study assessment (PSA) for PD-L1 companion diagnostic (CDx) device","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Rules Based Medicine Inc.","duties_or_roles":"Specialty Biomarker Laboratory, Exploratory Serum Biomarkers analysis","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, Customer Care / Site Logistics / Training / Equipment Customization","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Sample storage","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Tumor blocks/slides storage,PGX spl, spl storage for vendors,IHC,Legacy LabCorp Central Lab","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Multiple roles including Regulatory, SUSAR reporting and other operational duties (codes present in sponsorDuties)","organisation_type":"Pharmaceutical company"}