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Recruiting Phase 2

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)

NCT07680764 · tracked via the Priya Life Science Italy tracker
Phase
Phase 2
Started
2026-09-10
Last updated
2026-10-02

Condition(s) studied

Locally Advanced Non-Small Cell Lung Cancer (NSCLC)Metastatic Non-Small Cell Lung Cancer (NSCLC)

Investigational drug(s) / intervention(s)

Pumitamig →Imzokitug →Pemetrexed →Cisplatin →Carboplatin →Paclitaxel →

Pumitamig: Specified dose on specified days

Imzokitug: Specified dose on specified days

Pemetrexed: Specified dose on specified days

Cisplatin: Specified dose on specified days

Carboplatin: Specified dose on specified days

Paclitaxel: Specified dose on specified days

Study summary

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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Objective response rate (ORR) by investigator (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1) — Up to approximately 4 years

Trial sites (73)

FacilityCityRegionStatus
Local Institution - 0183 Washington D.C. District of Columbia Not Yet Recruiting
University Cancer & Blood Center, LLC Athens Georgia Recruiting
Local Institution - 0034 Lexington Kentucky Not Yet Recruiting
Local Institution - 0171 Lexington Kentucky Not Yet Recruiting
Local Institution - 0123 Baltimore Maryland Not Yet Recruiting
Local Institution - 0180 Hattiesburg Mississippi Not Yet Recruiting
Nebraska Cancer Specialists Grand Island Nebraska Recruiting
Oncology Hematology West PC Omaha Nebraska Recruiting
Local Institution - 0080 New York New York Not Yet Recruiting
Local Institution - 0176 Columbus Ohio Not Yet Recruiting
Local Institution - 0095 Houston Texas Not Yet Recruiting
Local Institution - 0135 Madison Wisconsin Not Yet Recruiting
Sanatorio Parque Rosario Rosario Santa Fe Province Recruiting
Instituto Medico Especializado Alexander Fleming Buenos Aires Argentina Recruiting
Clinica Viedma S.A. Viedma Argentina Recruiting
Local Institution - 0074 Gosford New South Wales Not Yet Recruiting
Local Institution - 0134 Westmead New South Wales Not Yet Recruiting
Local Institution - 0167 Greenslopes Queensland Not Yet Recruiting
Local Institution - 0100 Heidelberg Victoria Not Yet Recruiting
St. John of God Murdoch Hospital Perth Western Australia Recruiting
Local Institution - 0003 Natal/RN Rio Grande do Norte Not Yet Recruiting
Local Institution - 0006 Porto Alegre Rio Grande do Sul Not Yet Recruiting
Local Institution - 0005 Barretos São Paulo Not Yet Recruiting
Local Institution - 0001 São Paulo Brazil Not Yet Recruiting
Local Institution - 0081 Santiago Santiago Metropolitan Not Yet Recruiting
Local Institution - 0149 Santiago Santiago Metropolitan Not Yet Recruiting
Local Institution - 0084 Viña del Mar Valparaiso Not Yet Recruiting
Local Institution - 0038 Beijing Beijing Municipality Not Yet Recruiting
Local Institution - 0138 Fuzhou Fujian Not Yet Recruiting
Local Institution - 0050 Wuhan Hubei Not Yet Recruiting
Local Institution - 0147 Nanjing Jiangsu Not Yet Recruiting
Local Institution - 0140 Shanghai Shanghai Municipality Not Yet Recruiting
Local Institution - 0169 Shanghai Shanghai Municipality Not Yet Recruiting
Local Institution - 0144 Chengdu Sichuan Not Yet Recruiting
Local Institution - 0137 Hangzhou Zhejiang Not Yet Recruiting
Local Institution - 0131 Nice Alpes-Maritimes Not Yet Recruiting
Local Institution - 0087 Montpellier Languedoc-Roussillon Not Yet Recruiting
Local Institution - 0119 Villejuif Val-de-Marne Not Yet Recruiting
Local Institution - 0047 Grenoble France Not Yet Recruiting
Assistance Publique Hôpitaux de Marseille - Hôpital Nord Marseille France Recruiting

+ 33 more sites — see the full list on the official registry below.

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 NCT07680764 on ClinicalTrials.gov ↗ ← All trials in Italy