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Early-Stage Non-Small Cell Lung CancerPhase 2NCT07871214

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)

A Phase 2 study testing Pumitamig, Carboplatin and Cisplatin in people with Early-Stage Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 50 sites in 14 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Early-Stage Non-Small Cell Lung Cancer
What is being tested?
Pumitamig, Carboplatin and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
50 sitesin 14 countries
Study dates
30 Nov 2026to 15 Mar 2028
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

50 sites in 14 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

50 sites in 14 countries

United States9 sites

  • Local Institution - 0080

    Chestnut Hill, Massachusetts, 02459

    Site 0080

  • Local Institution - 0155

    Chicago, Illinois, 60611

    Site 0155

  • Local Institution - 0112

    Houston, Texas, 77030

    Site 0112

  • Local Institution - 0069

    Long Beach, California, 90806

    Site 0069

  • Local Institution - 0127

    Los Angeles, California, 90033

    Site 0127

  • Local Institution - 0185

    Nashville, Tennessee, 37232

    Site 0185

  • Local Institution - 0132

    Pittsburgh, Pennsylvania, 15232

    Site 0132

  • Local Institution - 0163

    Portland, Oregon, 97239

    Site 0163

  • Local Institution - 0136

    Tampa, Florida, 33612

Other trials in United States

China4 sites

  • Local Institution - 0019

    Beijing, 100044

    Site 0019

  • Local Institution - 0022

    Changsha Shi, Hunan, 410013

    Site 0022

  • Local Institution - 0013

    Chengdu, Sichuan, 610066

    Site 0013

  • Local Institution - 0158

    Shanghai, Shanghai Municipality, 200030

    Site 0158

Other trials in China

France4 sites

  • Local Institution - 0020

    Paris, Île-de-France Region, 75248

    Site 0020

  • Local Institution - 0212

    Rennes, Brittany Region, 35000

    Site 0212

  • Local Institution - 0021

    Toulouse, 31059

    Site 0021

  • Local Institution - 0015

    Villejuif, Val-De-Marne, 94805

    Site 0015

Other trials in France

Romania4 sites

  • Local Institution - 0178

    Bucharest, Bucharest, 20335

    Site 0178

  • Local Institution - 0024

    Bucharest, 22328

    Site 0024

  • Local Institution - 0014

    Cluj-Napoca, Cluj, 400015

    Site 0014

  • Local Institution - 0200

    Iași, 700483

    Site 0200

Other trials in Romania

Taiwan4 sites

  • Local Institution - 0012

    Taichung, 40705

    Site 0012

  • Local Institution - 0017

    Tainan, 70428

    Site 0017

  • Local Institution - 0011

    Taipei, 100225

    Site 0011

  • Local Institution - 0216

    Taipei, 114

    Site 0216

Other trials in Taiwan

Australia3 sites

  • Local Institution - 0211

    Fitzroy, Victoria, 3065

    Site 0211

  • Local Institution - 0009

    Murdoch, Western Australia, 6150

    Site 0009

  • Local Institution - 0023

    Woolloongabba, Queensland, 4102

    Site 0023

Other trials in Australia

Canada3 sites

  • Local Institution - 0182

    Calgary, Alberta, T2N5G2

    Site 0182

  • Local Institution - 0061

    Montreal, Quebec, H4A3J1

    Site 0061

  • Local Institution - 0106

    Oshawa, Ontario, L1G2B9

Other trials in Canada

Germany3 sites

  • Local Institution - 0205

    Cologne, North Rhine-Westphalia, 51109

    Site 0205

  • Local Institution - 0215

    Hamburg, 21075

    Site 0215

  • Local Institution - 0209

    Moers, North Rhine-Westphalia, 47441

    Site 0209

Other trials in Germany

Italy3 sites

  • Local Institution - 0056

    Aviano, Pordenone, 33081

    Site 0056

  • Local Institution - 0044

    Peschiera del Garda, Verona, 37019

    Site 0044

  • Local Institution - 0203

    Turin, 10060

    Site 0203

Other trials in Italy

Japan3 sites

  • Local Institution - 0005

    Kitakyushu, Fukuoka, 807-8556

    Site 0005

  • Local Institution - 0004

    Ōsaka-sayama, Osaka, 589-8511

    Site 0004

  • Local Institution - 0001

    Yokohama, Kanagawa, 241-8515

    Site 0001

Other trials in Japan

Spain3 sites

  • Local Institution - 0052

    Barcelona, 8035

    Site 0052

  • Local Institution - 0038

    Majadahonda, Madrid, 28222

    Site 0038

  • Local Institution - 0055

    Málaga, 29010

    Site 0055

Other trials in Spain

United Kingdom3 sites

  • Local Institution - 0031

    Leicester, East Midlands, LE15WW

    Site 0031

  • Local Institution - 0049

    London, EC1A7BE

    Site 0049

  • Local Institution - 0043

    Metropolitan Borough of Wirral, North West, CH634JY

    Site 0043

Other trials in United Kingdom

Poland2 sites

  • Local Institution - 0153

    Bydgoszcz, Kuyavian-Pomerania, 85-796

    Site 0153

  • Local Institution - 0087

    Gdansk, Pomeranian Voivodeship, 80-211

    Site 0087

Other trials in Poland

South Korea2 sites

  • Local Institution - 0006

    Seoul, 3722

    Site 0006

  • Local Institution - 0007

    Seoul, 8308

    Site 0007

Other trials in South Korea

About this study

Official title: ROSETTA Lung-220: A Phase 2, Open-Label, Multicenter, Multi-Arm Platform Study Evaluating Pumitamig and Other Novel Neoadjuvant Regimens in Participants With Resectable, Early-Stage (IIA to IIIB) Non-Small Cell Lung Cancer

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

Being tested
Pumitamig, Carboplatin, Cisplatin, Paclitaxel, Pemetrexed
Keywords
Participants with Stage IIA to IIIB considered surgical candidates
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PumitamigDrug

    Also called BMS-986545, BNT327

    Specified dose on specified days

  • CarboplatinDrug

    Specified dose on specified days

  • CisplatinDrug

    Specified dose on specified days

  • PaclitaxelDrug

    Specified dose on specified days

  • PemetrexedDrug

    Specified dose on specified days

Study groups in NCT07871214
Study groupRoleWhat they receive
Cohort A: PumitamigExperimentalNot described
Receives: Drug: Pumitamig; Drug: Carboplatin; Drug: Cisplatin; Drug: Paclitaxel; Drug: Pemetrexed
Cohort B: PumitamigExperimentalNot described
Receives: Drug: Pumitamig; Drug: Carboplatin; Drug: Cisplatin; Drug: Paclitaxel; Drug: Pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Achievement of pathologic complete response (pCR) by blinded independent pathology review (BIPR)

    Measured: Up to 6 weeks after last dose

Secondary outcomes (15)

  1. Incidence of all-causality

    Measured: Up to 5 years from safety follow-up

  2. Number of participants with treatment-related adverse events (TRAEs)

    Measured: Up to 90 days after surgery

  3. Number of participants with serious adverse events (SAEs)

    Measured: Up to 90 days after surgery

  4. Number of participants with immune related adverse events (irAEs)

    Measured: Up to 90 days after surgery

  5. Number of participants with bleeding events

    Measured: Up to 90 days after surgery

  6. Number of participants with adverse events (AEs) leading to dose delay

    Measured: Up to 90 days after surgery

  7. Number of participants with AEs leading to dose discontinuation

    Measured: Up to 90 days after surgery

  8. Number of deaths

    Measured: Up to 5 years

  9. Number of participants with laboratory abnormalities

    Measured: Up to 30 days before surgery

  10. Number of participants with surgery completion within 6 weeks after neoadjuvant therapy, without treatment-related cancellation, with documentation of resection status

    Measured: Up to 6 weeks after last dose

  11. Number of participants with delayed or cancelled surgery

    Measured: Up to 6 weeks after last dose

  12. Number of participants with AEs associated with surgery complications

    Measured: Up to 90 days after surgery

  13. Number of participants with SAEs associated with surgery complications

    Measured: Up to 90 days after surgery

  14. Achievement of major pathologic response (MPR) (by blinded independent pathology review (BIPR))

    Measured: Up to 6 weeks after last dose

  15. Event-free survival (EFS) (by investigator)

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2026
  2. Study start30 Nov 2026 (estimated)
  3. Primary completion15 Mar 2028 (estimated)
  4. Study completion15 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07871214
Sponsor's protocol ID
CA266-0020
Other IDs
2026-527590-11, U1111-1343-3078
Status last verified
Oct 2026
First submitted
7 Oct 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

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