Ireland
--:--IST
Starting soon Phase 2

A Study to Assess The Safety and Tolerability of Pumitamig-Based Therapy Administered Before Surgery in Participants With Early-Stage Non-Small Cell Lung Cancer (ROSETTA Lung-220)

NCT07871214 · tracked via the Priya Life Science UK tracker
Phase
Phase 2
Started
2026-11-30
Last updated
2026-10-13

Condition(s) studied

Early-Stage Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Pumitamig →Carboplatin →Cisplatin →Paclitaxel →Pemetrexed →

Pumitamig: Specified dose on specified days

Carboplatin: Specified dose on specified days

Cisplatin: Specified dose on specified days

Paclitaxel: Specified dose on specified days

Pemetrexed: Specified dose on specified days

Study summary

The purpose of this study is to assess the safety, tolerability, and surgical feasibility of preoperative Pumitamig-based therapy and other molecules in resectable, Early-Stage Non-Small Cell Lung Cancer

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria * Participants must have newly diagnosed, previously untreated participants with histologically confirmed non-small cell lung cancer (NSCLC) (squamous or non-squamous histology); resectable Stage IIA to IIIB (N2) disease (American Joint Committee on Cancer (AJCC) 9th edition). * Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Participants must have an evaluable programmed death-ligand 1 (PD-L1) expression. Exclusion Criteria * Participants must not have unresectable disease, N3 nodal involvement, or any evidence of distant metastatic disease (M1) at baseline assessment (suspected or confirmed). * Participants must not have active, known autoimmune disease. * Participants must not have significant cardiovascular impairment as evidenced by uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias or major thrombotic or embolic events. * Participants must not have advanced/clinically significant lung disease (within 6 months prior to randomization) or history of interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids (≥ Grade 2), or who have current or suspected ILD or pneumonitis. * Participants must not have significant risk of bleeding or history of major hemorrhagic events (including gastrointestinal (GI) hemorrhage or hemorrhagic stroke). * Participants must not have GI or non-GI fistula, GI perforation, or intra-abdominal abscess. * Participants must not have prior systemic anticancer therapy, radiotherapy, or investigational therapy for NSCLC or contraindication to curative-intent surgery or study-specified chemotherapy. * Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

  • Achievement of pathologic complete response (pCR) by blinded independent pathology review (BIPR) — Up to 6 weeks after last dose

Trial sites (50)

FacilityCityRegionStatus
Local Institution - 0069 Long Beach California
Local Institution - 0127 Los Angeles California
Local Institution - 0136 Tampa Florida
Local Institution - 0155 Chicago Illinois
Local Institution - 0080 Chestnut Hill Massachusetts
Local Institution - 0163 Portland Oregon
Local Institution - 0132 Pittsburgh Pennsylvania
Local Institution - 0185 Nashville Tennessee
Local Institution - 0112 Houston Texas
Local Institution - 0023 Woolloongabba Queensland
Local Institution - 0211 Fitzroy Victoria
Local Institution - 0009 Murdoch Western Australia
Local Institution - 0182 Calgary Alberta
Local Institution - 0106 Oshawa Ontario
Local Institution - 0061 Montreal Quebec
Local Institution - 0022 Changsha Shi Hunan
Local Institution - 0158 Shanghai Shanghai Municipality
Local Institution - 0013 Chengdu Sichuan
Local Institution - 0019 Beijing China
Local Institution - 0212 Rennes Brittany Region
Local Institution - 0015 Villejuif Val-De-Marne
Local Institution - 0021 Toulouse France
Local Institution - 0020 Paris Île-de-France Region
Local Institution - 0205 Cologne North Rhine-Westphalia
Local Institution - 0209 Moers North Rhine-Westphalia
Local Institution - 0215 Hamburg Germany
Local Institution - 0056 Aviano Pordenone
Local Institution - 0044 Peschiera del Garda Verona
Local Institution - 0203 Turin Italy
Local Institution - 0005 Kitakyushu Fukuoka
Local Institution - 0001 Yokohama Kanagawa
Local Institution - 0004 Ōsaka-sayama Osaka
Local Institution - 0153 Bydgoszcz Kuyavian-Pomerania
Local Institution - 0087 Gdansk Pomeranian Voivodeship
Local Institution - 0178 Bucharest Bucharest
Local Institution - 0014 Cluj-Napoca Cluj
Local Institution - 0024 Bucharest Romania
Local Institution - 0200 Iași Romania
Local Institution - 0006 Seoul South Korea
Local Institution - 0007 Seoul South Korea

+ 10 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 NCT07871214 on ClinicalTrials.gov ↗ ← All trials in the UK