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Not yet recruitingNCT07871214Updated Oct 13, 2026

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 interventional study of Pumitamig and Carboplatin in Early-Stage Non-Small Cell Lung Cancer, sponsored by Bristol-Myers Squibb. Not yet recruiting at 50 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment

Updated Oct 13, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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

02

Conditions studied

  • Early-Stage Non-Small Cell Lung Cancer

Keywords

  • Participants with Stage IIA to IIIB considered surgical candidates
03

In context

Carcinoma, Non-Small-Cell Lung

6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

This study's planned enrollment of 80 is above the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,562 studies on the registry; 118 are open to participants now.

Of its 435 completed or terminated interventional studies of FDA-regulated products, 227 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Cohort A: Pumitamig

    Drug: Pumitamig · Drug: Carboplatin · Drug: Cisplatin · Drug: Paclitaxel · Drug: Pemetrexed

  • Experimental
    Cohort B: Pumitamig

    Drug: Pumitamig · Drug: Carboplatin · Drug: Cisplatin · Drug: Paclitaxel · Drug: Pemetrexed

Interventions

  • Specified dose on specified days

    Also known as: BMS-986545, BNT327

  • Specified dose on specified days

  • Specified dose on specified days

  • Specified dose on specified days

  • Specified dose on specified days

06

What researchers measure

Primary outcomes

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

    Time frame: Up to 6 weeks after last dose

Secondary outcomes

  1. Incidence of all-causality

    Time frame: Up to 5 years from safety follow-up

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

    Time frame: Up to 90 days after surgery

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

    Time frame: Up to 90 days after surgery

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

    Time frame: Up to 90 days after surgery

  5. Number of participants with bleeding events

    Time frame: Up to 90 days after surgery

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

    Time frame: Up to 90 days after surgery

  7. Number of participants with AEs leading to dose discontinuation

    Time frame: Up to 90 days after surgery

  8. Number of deaths

    Time frame: Up to 5 years

  9. Number of participants with laboratory abnormalities

    Time frame: 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

    Time frame: Up to 6 weeks after last dose

  11. Number of participants with delayed or cancelled surgery

    Time frame: Up to 6 weeks after last dose

  12. Number of participants with AEs associated with surgery complications

    Time frame: Up to 90 days after surgery

  13. Number of participants with SAEs associated with surgery complications

    Time frame: Up to 90 days after surgery

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

    Time frame: Up to 6 weeks after last dose

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

    Time frame: Up to 5 years

07

Study locations

50 sites
  • Local Institution - 0069
    Long Beach, California 90806, United States
    • Site 0069 · Contact
  • Local Institution - 0127
    Los Angeles, California 90033, United States
    • Site 0127 · Contact
  • Local Institution - 0136
    Tampa, Florida 33612, United States
  • Local Institution - 0155
    Chicago, Illinois 60611, United States
    • Site 0155 · Contact
  • Local Institution - 0080
    Chestnut Hill, Massachusetts 02459, United States
    • Site 0080 · Contact
  • Local Institution - 0163
    Portland, Oregon 97239, United States
    • Site 0163 · Contact
  • Local Institution - 0132
    Pittsburgh, Pennsylvania 15232, United States
    • Site 0132 · Contact
  • Local Institution - 0185
    Nashville, Tennessee 37232, United States
    • Site 0185 · Contact
  • Local Institution - 0112
    Houston, Texas 77030, United States
    • Site 0112 · Contact
  • Local Institution - 0023
    Woolloongabba, Queensland 4102, Australia
    • Site 0023 · Contact
  • Local Institution - 0211
    Fitzroy, Victoria 3065, Australia
    • Site 0211 · Contact
  • Local Institution - 0009
    Murdoch, Western Australia 6150, Australia
    • Site 0009 · Contact
  • Local Institution - 0182
    Calgary, Alberta T2N5G2, Canada
    • Site 0182 · Contact
  • Local Institution - 0106
    Oshawa, Ontario L1G2B9, Canada
  • Local Institution - 0061
    Montreal, Quebec H4A3J1, Canada
    • Site 0061 · Contact
  • Local Institution - 0022
    Changsha Shi, Hunan 410013, China
    • Site 0022 · Contact
  • Local Institution - 0158
    Shanghai, Shanghai Municipality 200030, China
    • Site 0158 · Contact
  • Local Institution - 0013
    Chengdu, Sichuan 610066, China
    • Site 0013 · Contact
  • Local Institution - 0019
    Beijing, 100044, China
    • Site 0019 · Contact
  • Local Institution - 0212
    Rennes, Brittany Region 35000, France
    • Site 0212 · Contact
  • Local Institution - 0015
    Villejuif, Val-De-Marne 94805, France
    • Site 0015 · Contact
  • Local Institution - 0021
    Toulouse, 31059, France
    • Site 0021 · Contact
  • Local Institution - 0020
    Paris, Île-de-France Region 75248, France
    • Site 0020 · Contact
  • Local Institution - 0205
    Cologne, North Rhine-Westphalia 51109, Germany
    • Site 0205 · Contact
  • Local Institution - 0209
    Moers, North Rhine-Westphalia 47441, Germany
    • Site 0209 · Contact
  • Local Institution - 0215
    Hamburg, 21075, Germany
    • Site 0215 · Contact
  • Local Institution - 0056
    Aviano, Pordenone 33081, Italy
    • Site 0056 · Contact
  • Local Institution - 0044
    Peschiera del Garda, Verona 37019, Italy
    • Site 0044 · Contact
  • Local Institution - 0203
    Turin, 10060, Italy
    • Site 0203 · Contact
  • Local Institution - 0005
    Kitakyushu, Fukuoka 807-8556, Japan
    • Site 0005 · Contact
  • Local Institution - 0001
    Yokohama, Kanagawa 241-8515, Japan
    • Site 0001 · Contact
  • Local Institution - 0004
    Ōsaka-sayama, Osaka 589-8511, Japan
    • Site 0004 · Contact
  • Local Institution - 0153
    Bydgoszcz, Kuyavian-Pomerania 85-796, Poland
    • Site 0153 · Contact
  • Local Institution - 0087
    Gdansk, Pomeranian Voivodeship 80-211, Poland
    • Site 0087 · Contact
  • Local Institution - 0178
    Bucharest, Bucharest 20335, Romania
    • Site 0178 · Contact
  • Local Institution - 0014
    Cluj-Napoca, Cluj 400015, Romania
    • Site 0014 · Contact
  • Local Institution - 0024
    Bucharest, 22328, Romania
    • Site 0024 · Contact
  • Local Institution - 0200
    Iași, 700483, Romania
    • Site 0200 · Contact
  • Local Institution - 0006
    Seoul, 3722, South Korea
    • Site 0006 · Contact
  • Local Institution - 0007
    Seoul, 8308, South Korea
    • Site 0007 · Contact
  • Local Institution - 0038
    Majadahonda, Madrid 28222, Spain
    • Site 0038 · Contact
  • Local Institution - 0052
    Barcelona, 8035, Spain
    • Site 0052 · Contact
  • Local Institution - 0055
    Málaga, 29010, Spain
    • Site 0055 · Contact
  • Local Institution - 0012
    Taichung, 40705, Taiwan
    • Site 0012 · Contact
  • Local Institution - 0017
    Tainan, 70428, Taiwan
    • Site 0017 · Contact
  • Local Institution - 0011
    Taipei, 100225, Taiwan
    • Site 0011 · Contact
  • Local Institution - 0216
    Taipei, 114, Taiwan
    • Site 0216 · Contact
  • Local Institution - 0031
    Leicester, East Midlands LE15WW, United Kingdom
    • Site 0031 · Contact
  • Local Institution - 0043
    Metropolitan Borough of Wirral, North West CH634JY, United Kingdom
    • Site 0043 · Contact
  • Local Institution - 0049
    London, EC1A7BE, United Kingdom
    • Site 0049 · Contact
08

References and documents

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: See Plan Description

Access criteria: See Plan Description

Data sharing details ↗ · www.bms.com

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Mar 2028, 15 months later.

Of 292 industry-sponsored phase 2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 59. This study's planned 15 months is below that.

Counting every sponsor, half of 970 studies reached it within 48 months; a quarter within 30 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 7, 2026
First posted
Oct 13, 2026
StartEst.
Nov 30, 2026
Primary completionEst.
Mar 15, 2028
CompletionEst.
Mar 15, 2028
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07871214
Collaborators
BioNTech SE
Responsible party
Sponsor
First posted
Oct 13, 2026
Start date
Nov 30, 2026 (estimated)
Primary completion
Mar 15, 2028 (estimated)
Completion
Mar 15, 2028 (estimated)
Last update
Oct 13, 2026

Study contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Contact
Clinical.Trials@bms.com
855-907-3286
First line of the email MUST contain NCT # and Site #.
Contact
Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Pumitamig

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