Recruiting NCT07680764
A Study To Assess the Safety, Tolerability, and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pumitamig, Imzokitug.
- Who it may be relevant to
- Registry conditions: Locally Advanced Non-Small Cell Lung Cancer (NSCLC), Metastatic Non-Small Cell Lung Cancer (NSCLC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Brazil, Chile +7
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2, Randomized, Open-label, Study Assessing the Safety, Tolerability and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Overview
The purpose of this study is to assess the safety, tolerability, and efficacy of Imzokitug in combination with Pumitamig and Platinum-Doublet Chemotherapy (PDCT) versus Pumitamig and PDCT as first-line treatment for participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Interventions
- Drug Pumitamig
Specified dose on specified days - Drug Imzokitug
Specified dose on specified days
Primary outcome measures
- Objective response rate (ORR) by investigator (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1) [Time frame: Up to approximately 4 years]
Secondary outcome measures (10)
- Number of participants with adverse events (AEs) [Time frame: Up to 90 days after discontinuation of study treatment]
- Number of participants with serious adverse events (SAEs) [Time frame: Up to 90 days after discontinuation of study treatment]
- Number of participants with treatment-related AEs [Time frame: Up to 90 days after discontinuation of study treatment]
- Number of participants with treatment-related SAEs [Time frame: Up to 90 days after discontinuation of study treatment]
- Number of participants with AEs leading to discontinuation [Time frame: Up to 90 days after discontinuation of study treatment]
- Number of deaths [Time frame: Up to 90 days after discontinuation of study treatment]
- Progression free survival (PFS) by investigator (per RECIST v1.1) [Time frame: Up to approximately 4 years]
- Overall survival (OS) [Time frame: Up to approximately 4 years]
- Duration of response (DOR) by investigator (per RECIST v1.1) [Time frame: Up to approximately 4 years]
- Time to recurrence (TTR) by investigator (per RECIST v1.1) [Time frame: Up to approximately 4 years]
Eligibility criteria
Inclusion criteria
- Participants must have histologically confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC) (squamous or non-squamous) or recurrent unresectable disease per the American joint committee on cancer (AJCC) Staging System 9th edition.
- Participants must have no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease.
- Tumor tissue (fresh or archival) obtained within 5 months of enrollment (signing of informed consent) for each participant must be submitted by the site.
- Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Exclusion criteria
- Participants must not have any documented actionable genomic alterations (AGAs) for which first line approved targeted therapies are indicated.
- Participants must not have prior treatment with immuno-oncology therapies.
- Participants must not have untreated central nervous system (CNS) metastases.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 11 centers
- Local Institution - 0170 — Athens
- Local Institution - 0034 — Lexington
- Local Institution - 0171 — Lexington
- Local Institution - 0123 — Baltimore
- Local Institution - 0180 — Hattiesburg
- Nebraska Cancer Specialists — Grand Island
- Oncology Hematology West PC — Omaha
- Local Institution - 0080 — New York
- … and 3 more centers
China · 8 centers
- Local Institution - 0038 — Beijing
- Local Institution - 0138 — Fuzhou
- Local Institution - 0050 — Wuhan
- Local Institution - 0147 — Nanjing
- Local Institution - 0140 — Shanghai
- Local Institution - 0169 — Shanghai
- Local Institution - 0144 — Chengdu
- Local Institution - 0137 — Hangzhou
France · 8 centers
- Local Institution - 0131 — Nice
- Local Institution - 0110 — Marseille
- Local Institution - 0087 — Montpellier
- Local Institution - 0119 — Villejuif
- Local Institution - 0047 — Grenoble
- Local Institution - 0109 — Paris
- Local Institution - 0085 — Saint-Herblain
- Local Institution - 0019 — Paris
Spain · 8 centers
- Local Institution - 0132 — Badalona
- Local Institution - 0162 — Seville
- Local Institution - 0027 — Barcelona
- Local Institution - 0068 — Barcelona
- Local Institution - 0163 — Barcelona
- Local Institution - 0041 — Madrid
- Local Institution - 0010 — Majadahonda
- Local Institution - 0020 — Málaga
Romania · 7 centers
- Local Institution - 0114 — Florești
- Local Institution - 0113 — Timișoara
- Local Institution - 0076 — Bucharest
- Local Institution - 0008 — Cluj-Napoca
- Local Institution - 0075 — Craiova
- Local Institution - 0115 — Iași
- Local Institution - 0116 — Iași
Germany · 6 centers
- Local Institution - 0126 — Stuttgart
- Local Institution - 0156 — Marburg
- Local Institution - 0152 — Homburg
- Local Institution - 0065 — Cologne
- Local Institution - 0042 — Haile
- Local Institution - 0125 — Hessen
Italy · 6 centers
- Local Institution - 0128 — Misterbianco
- Local Institution - 0043 — Bari
- Local Institution - 0148 — Bergamo
- Local Institution - 0159 — Milan
- Local Institution - 0014 — Ravenna
- Local Institution - 0011 — Rozzano (MI)
Australia · 5 centers
- Local Institution - 0074 — Gosford
- Local Institution - 0134 — Westmead
- Local Institution - 0167 — Greenslopes
- Local Institution - 0100 — Heidelberg
- Local Institution - 0048 — Perth
Brazil · 4 centers
- Local Institution - 0003 — Natal/RN
- Local Institution - 0006 — Porto Alegre
- Local Institution - 0005 — Barretos
- Local Institution - 0001 — São Paulo
Argentina · 3 centers
- Local Institution - 0092 — Viedma
- Local Institution - 0082 — Rosario
- Local Institution - 0094 — Buenos Aires
Chile · 3 centers
- Local Institution - 0081 — Santiago
- Local Institution - 0149 — Santiago
- Local Institution - 0084 — Viña del Mar
United Kingdom · 2 centers
- Local Institution - 0035 — London
- Local Institution - 0037 — Guildford
Identifiers
NCT: NCT07680764 · CA052-1000 · 2026-525170-19 · U1111-1333-5867