Non-Small Cell Lung CancerPhase 3NCT07680790

Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02)

A Phase 3 study testing Iza-bren, Osimertinib and Pemetrexed in people with Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 201 sites in 16 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate izalontamab brengitecan (iza-bren) combined with osimertinib in participants with previously untreated, locally advanced or metastatic EGFR-mutant NSCLC, compared to osimertinib alone or osimertinib combined with platinum-based chemotherapy Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer
What is being tested?: Iza-bren, Osimertinib and Pemetrexed
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 850 participants
Where: 201 sitesin 16 countries
Study dates: 8 Sep 2026to 30 Dec 2031
Phase: Phase 3

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 histologically or cytologically confirmed non-squamous NSCLC, newly diagnosed locally advanced (Stage IIIB/IIIC), metastatic (Stage IVA/IVB), or recurrent disease not amenable to curative surgery or definitive radiotherapy and requiring systemic treatment
Participants must have documented EGFR-TKI-sensitizing mutation (exon 19 deletion or exon 21 L858R substitution)
Participants must have measurable extracranial disease per RECIST v1.1 as assessed by the investigator
Participants must have ECOG Performance Status 0-1

Who cannot join

Participants must not have unstable, symptomatic, or uncontrolled CNS metastases, including brain, leptomeningeal disease, and/or spinal cord compression
Participants must not have history of ILD/pneumonitis requiring treatment with steroids (≥ Grade 2), or current or suspected ILD/pneumonitis
Participants must not have clinically significant cardiac disease
Other protocol-defined inclusion/exclusion criteria apply.

Trial locations and contacts

201 sites in 16 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

Country

City, postcode or hospital

Sites recruiting now only

201 sites in 16 countries

China43 sites, 41 recruiting

Local Institution - 0298
Anyang, Henan, 455000
Site 0298
Not yet recruiting
Local Institution - 0517
Beijing, Beijing Municipality, 100142
Site 0517
Not yet recruiting
Local Institution - 0458
Beijing, Beijing Municipality, 101149
Site 0458
Not yet recruiting
Local Institution - 0479
Binzhou, Shandong, 256603
Site 0479
Not yet recruiting
Local Institution - 0482
Changsha, Hunan, 410007
Site 0482
Not yet recruiting
Local Institution - 0467
Changsha, Hunan, 410008
Site 0467
Not yet recruiting
Local Institution - 0306
Changsha Shi, Hunan, 410013
Site 0306
Not yet recruiting
Local Institution - 0456
Chengdu, Sichuan, 610041
Site 0456
Not yet recruiting
Local Institution - 0471
Chengdu, Sichuan, 610041
Withdrawn
Local Institution - 0534
Chengdu, Sichuan, 610041
Site 0534
Not yet recruiting
Local Institution - 0535
Chongqing, Chongqing Municipality, 0
Site 0535
Not yet recruiting
Local Institution - 0470
Chongqing, Chongqing Municipality, 400030
Site 0470
Not yet recruiting
Local Institution - 0320
Dazhou Shi, Sichuan, 635000
Site 0320
Not yet recruiting
Local Institution - 0326
Dongguan Shi, Guangdong, 523059
Site 0326
Not yet recruiting
Local Institution - 0493
Fuzhou, Fujian, 350001
Site 0493
Not yet recruiting
Local Institution - 0457
Fuzhou, Fujian, 350014
Site 0457
Not yet recruiting
Local Institution - 0331
Guangzhou, Guangdong, 510080
Site 0331
Not yet recruiting
Local Institution - 0321
Guilin, Guangxi, 541199
Site 0321
Not yet recruiting
Local Institution - 0505
Guiyang, Guizhou, 550003
Site 0505
Not yet recruiting
Local Institution - 0330
Haikou, Hainan, 570000
Site 0330
Not yet recruiting
Local Institution - 0312
Hangzhou, Zhejiang, 310022
Site 0312
Not yet recruiting
Local Institution - 0343
Harbin, Heilongjiang, 150081
Site 0343
Not yet recruiting
Local Institution - 0512
Jiangmen, Guangdong, 529000
Site 0512
Not yet recruiting
Local Institution - 0455
Jinan, Shandong, 250117
Site 0455
Not yet recruiting
Local Institution - 0483
Jingzhou, Hubei, 0
Site 0483
Not yet recruiting
Local Institution - 0531
Lianyungang, Jiangsu, 222061
Site 0531
Not yet recruiting
Local Institution - 0413
Linyi, Shandong, 276027
Site 0413
Not yet recruiting
Local Institution - 0347
Nanjing, Jiangsu, 210029
Site 0347
Not yet recruiting
Local Institution - 0328
Nanning, Guangxi, 530021
Site 0328
Not yet recruiting
Local Institution - 0319
Shanghai Shi, Shanghai Municipality, 200120
Site 0319
Not yet recruiting
Local Institution - 0332
Shenyang, Liaoning, 110042
Site 0332
Not yet recruiting
Local Institution - 0322
Shijiazhuang, Hebei, 050035
Site 0322
Not yet recruiting
Local Institution - 0316
Taiyuan, Shanxi, 30001
Site 0316
Not yet recruiting
Local Institution - 0463
Taiyuan, Shanxi, 30013
Site 0463
Not yet recruiting
Local Institution - 0452
Tianjin, Tianjin Municipality, 300060
Site 0452
Not yet recruiting
Local Institution - 0469
Weifang Shi, Shandong, 261000
Site 0469
Not yet recruiting
Local Institution - 0341
Weihui Shi, Henan, 453100
Site 0341
Not yet recruiting
Local Institution - 0450
Wuhan, Hubei, 430022
Site 0450
Not yet recruiting
Local Institution - 0464
Xi'an, Shaanxi, 710038
Withdrawn
Local Institution - 0472
Yibin, Sichuan, 644000
Site 0472
Not yet recruiting
Local Institution - 0480
Zhengzhou, Henan, 450000
Site 0480
Not yet recruiting
Local Institution - 0423
Zhengzhou, Henan, 450008
Site 0423
Not yet recruiting
Local Institution - 0478
Zhongshan, Guangdong, 528403
Site 0478
Not yet recruiting

Other trials in China

United States35 sites, 35 recruiting

Local Institution - 0503
Baltimore, Maryland, 21202
Site 0503
Not yet recruiting
Texas Oncology
Beaumont, Texas, 77702
Ashok Malani, Site 0522, 713-792-2740
Recruiting
Local Institution - 0212
Beverly Hills, California, 90211
Site 0212
Not yet recruiting
Local Institution - 0520
Boulder, Colorado, 80304
Site 0520
Not yet recruiting
Local Institution - 0385
Charlotte, North Carolina, 28204
Site 0385
Not yet recruiting
Local Institution - 0525
Dallas, Texas, 75246
Site 0525
Not yet recruiting
Local Institution - 0487
Easton, Pennsylvania, 18045
Site 0487
Not yet recruiting
Local Institution - 0521
Edina, Minnesota, 55435-2150
Site 0521
Not yet recruiting
Local Institution - 0165
Fairfax, Virginia, 22031
Site 0165
Not yet recruiting
Local Institution - 0530
Fairfax, Virginia, 22031
Site 0530
Not yet recruiting
Local Institution - 0527
Fort Myers, Florida, 33901
Site 0527
Not yet recruiting
Local Institution - 0504
Fullerton, California, 92835
Site 0504
Not yet recruiting
Local Institution - 0357
La Jolla, California, 92093
Site 0357
Not yet recruiting
Local Institution - 0290
Lebanon, New Hampshire, 03756
Site 0290
Not yet recruiting
Local Institution - 0199
Memphis, Tennessee, 38120
Site 0199
Not yet recruiting
Local Institution - 0502
Morgantown, West Virginia, 26505
Site 0502
Not yet recruiting
Local Institution - 0183
New Brunswick, New Jersey, 08901
Site 0183
Not yet recruiting
Local Institution - 0153
New York, New York, 10021
Site 0153
Not yet recruiting
Local Institution - 0402
Omaha, Nebraska, 68198
Site 0402
Not yet recruiting
Local Institution - 0366
Orlando, Florida, 32806
Site 0366
Not yet recruiting
Local Institution - 0207
Ottawa, Illinois, 61350
Site 0207
Not yet recruiting
Cancer Care Centers of Brevard - Rockledge
Palm Bay, Florida, 32901
Venkat Pavan Kancharla, Site 0519, 111-111-1111
Recruiting
Local Institution - 0404
Portland, Oregon, 97213
Site 0404
Not yet recruiting
Local Institution - 0364
Saint Paul, Minnesota, 55102
Site 0364
Not yet recruiting
Local Institution - 0411
Salt Lake City, Utah, 84112
Site 0411
Not yet recruiting
Texas Oncology - San Antonio
San Antonio, Texas, 78217
Krishna Alluri, Site 0529, 210-656-7177
Recruiting
Local Institution - 0438
Sandusky, Ohio, 44870
Site 0438
Not yet recruiting
Local Institution - 0283
Seattle, Washington, 98104
Site 0283
Not yet recruiting
Local Institution - 0523
Silver Spring, Maryland, 20904
Site 0523
Not yet recruiting
Local Institution - 0200
Sioux Falls, South Dakota, 57104
Site 0200
Not yet recruiting
Local Institution - 0403
St Louis, Missouri, 63110
Site 0403
Not yet recruiting
Local Institution - 0526
St. Petersburg, Florida, 33701
Site 0526
Not yet recruiting
Local Institution - 0157
The Bronx, New York, 10461
Site 0157
Not yet recruiting
Local Institution - 0524
West Palm Beach, Florida, 33401
Site 0524
Not yet recruiting
Shenandoah Oncology, P.C. (Shenandoah Oncology Associates, P.C.)
Winchester, Virginia, 22601
Michael McCusker Jr., Site 0528
Recruiting

Other trials in United States

Germany15 sites, 15 recruiting

Local Institution - 0100
Cologne, North Rhine-Westphalia, 50937
Site 0100
Not yet recruiting
Local Institution - 0243
Dortmund, North Rhine-Westphalia, 44263
Site 0243
Not yet recruiting
Local Institution - 0103
Dresden, Saxony, 1307
Site 0103
Not yet recruiting
Local Institution - 0104
Essen, North Rhine-Westphalia, 45147
Site 0104
Not yet recruiting
Local Institution - 0446
Frankfurt am Main, Hesse, 60389
Site 0446
Not yet recruiting
Local Institution - 0112
Gerlingen, Baden-Wurttemberg, 70839
Site 0112
Not yet recruiting
Local Institution - 0445
Giessen, 35392
Site 0445
Not yet recruiting
Local Institution - 0108
Großhansdorf, Schleswig-Holstein, 22927
Site 0108
Not yet recruiting
Local Institution - 0117
Hemer, North Rhine-Westphalia, 58675
Site 0117
Not yet recruiting
Local Institution - 0412
Leipzig, Saxony, 4103
Site 0412
Not yet recruiting
Local Institution - 0239
Lübeck, Schleswig-Holstein, 23538
Site 0239
Not yet recruiting
Local Institution - 0001
Munich, Bavaria, 81377
Site 0001
Not yet recruiting
Local Institution - 0101
Münster, North Rhine-Westphalia, 48149
Site 0101
Not yet recruiting
Local Institution - 0106
Oldenburg, Lower Saxony, 26121
Site 0106
Not yet recruiting
Local Institution - 0105
Regensburg, Bavaria, 93053
Site 0105
Not yet recruiting

Other trials in Germany

France12 sites, 12 recruiting

Local Institution - 0073
Brest, 29200
Site 0073
Not yet recruiting
Local Institution - 0062
Bron, Rhône, 69677
Site 0062
Not yet recruiting
Local Institution - 0066
Caen, 14076
Site 0066
Not yet recruiting
Local Institution - 0063
Dijon, Côte-D'Or, 21079
Site 0063
Not yet recruiting
Local Institution - 0064
La Tronche, Nan, 38700
Site 0064
Not yet recruiting
Local Institution - 0116
Lyon, Nan, 69373
Site 0116
Not yet recruiting
Local Institution - 0074
Marseille, Bouches-Du-Rhône, 13915
Site 0074
Not yet recruiting
Local Institution - 0075
Nantes, Loire Atlantique, 44093
Site 0075
Not yet recruiting
Local Institution - 0109
Paris, Nan, 75014
Site 0109
Not yet recruiting
Local Institution - 0071
Paris, Île-de-France Region, 75248
Site 0071
Not yet recruiting
Local Institution - 0070
Toulouse, 31059
Site 0070
Not yet recruiting
Local Institution - 0069
Villejuif, Val-De-Marne, 94805
Site 0069
Not yet recruiting

Other trials in France

South Korea12 sites, 12 recruiting

Local Institution - 0138
Buk-Gu, Daegu, 41404
Site 0138
Not yet recruiting
Local Institution - 0140
Cheongju-si, Chungcheongbuk-do [Chungbuk], 28644
Site 0140
Not yet recruiting
Local Institution - 0506
Dalseo, Daegu, 42601
Site 0506
Not yet recruiting
Local Institution - 0127
Goyang-si, Gyeonggi-do, 410-769
Site 0127
Not yet recruiting
Local Institution - 0139
Gyeongsangnam-do, 050612
Site 0139
Not yet recruiting
Local Institution - 0134
Hwasun-Gun, Jeollanam-do, 58128
Site 0134
Not yet recruiting
Local Institution - 0124
Seocho -Gu, Seoul, 6591
Site 0124
Not yet recruiting
Local Institution - 0133
Seongnam-si, Gyeonggi-do, 13620
Site 0133
Not yet recruiting
Local Institution - 0131
Seoul, Seoul-teukbyeolsi [Seoul], 03080
Site 0131
Not yet recruiting
Local Institution - 0135
Seoul, 120-752
Site 0135
Not yet recruiting
Local Institution - 0126
Seoul, 8308
Site 0126
Not yet recruiting
Local Institution - 0123
Songpa-Gu, Seoul, 138-736
Site 0123
Not yet recruiting

Other trials in South Korea

Japan11 sites, 11 recruiting

Local Institution - 0137
Chūōku, Tokyo-To, 104-0045
Site 0137
Not yet recruiting
Local Institution - 0141
Hamamatsu, Shizuoka, 431-3192
Site 0141
Not yet recruiting
Local Institution - 0125
Hirakata-Shi, Osaka, 573-1191
Site 0125
Not yet recruiting
Local Institution - 0414
Kōtoku, Tokyo-To, 135-8550
Site 0414
Not yet recruiting
Local Institution - 0136
Kurume-Shi, Fukuoka, 830-0011
Site 0136
Not yet recruiting
Local Institution - 0262
Nagoya, Aichi-ken, 464-8681
Site 0262
Not yet recruiting
Local Institution - 0433
Okayama, Okayama-ken, 700-8558
Site 0433
Not yet recruiting
Local Institution - 0129
Osakasayama-Shi, Osaka, 589-8511
Site 0129
Not yet recruiting
Local Institution - 0122
Sendai, Miyagi, 980-0873
Site 0122
Not yet recruiting
Local Institution - 0128
Toon-Shi, Ehime, 791-0295
Site 0128
Not yet recruiting
Local Institution - 0121
Yokohama, Kanagawa, 241-8515
Site 0121
Not yet recruiting

Other trials in Japan

Turkey (Türkiye)11 sites, 11 recruiting

Local Institution - 0014
Adana, 1060
Site 0014
Not yet recruiting
Local Institution - 0019
Adana, 1370
Site 0019
Not yet recruiting
Local Institution - 0008
Ankara, 6680
Site 0008
Not yet recruiting
Local Institution - 0003
Ankara, 6800
Site 0003
Not yet recruiting
Local Institution - 0015
Antalya, 07100
Site 0015
Not yet recruiting
Local Institution - 0041
Istanbul, 34214
Site 0041
Not yet recruiting
Local Institution - 0039
Istanbul, 34295
Site 0039
Not yet recruiting
Local Institution - 0050
Izmir, 35110
Site 0050
Not yet recruiting
Local Institution - 0037
Izmir, 35530
Site 0037
Not yet recruiting
Local Institution - 0265
Pendik, Istanbul, 34340
Site 0265
Not yet recruiting
Local Institution - 0021
Sur, Diyarbakır, 21200
Site 0021
Not yet recruiting

Other trials in Turkey (Türkiye)

Brazil9 sites, 9 recruiting

Local Institution - 0244
Barretos, São Paulo, 14784-400
Site 0244
Not yet recruiting
Local Institution - 0249
Campinas, São Paulo, 13060-803
Site 0249
Not yet recruiting
Local Institution - 0252
Florianópolis, Santa Catarina, 88020
Site 0252
Not yet recruiting
Local Institution - 0247
Ijuí, Rio Grande do Sul, 98700-000
Site 0247
Not yet recruiting
Local Institution - 0255
Rio de Janeiro, 20230-130
Site 0255
Not yet recruiting
Local Institution - 0291
Salvador, Estado de Bahia, 40170-110
Site 0291
Not yet recruiting
Local Institution - 0259
São Paulo, 01246-000
Site 0259
Not yet recruiting
Local Institution - 0261
Sorocaba, São Paulo, 18030-005
Site 0261
Not yet recruiting
Local Institution - 0253
Vitória, Espírito Santo, 29043-260
Site 0253
Not yet recruiting

Other trials in Brazil

Italy9 sites, 9 recruiting

Local Institution - 0093
Bergamo, 24128
Site 0093
Not yet recruiting
Local Institution - 0289
Brescia, 25123
Site 0289
Not yet recruiting
Local Institution - 0094
Candiolo, Turin, 10060
Site 0094
Not yet recruiting
Local Institution - 0236
Meldola, Forli-Cesena, 47014
Site 0236
Not yet recruiting
Local Institution - 0089
Milan, 20133
Site 0089
Not yet recruiting
Local Institution - 0087
Milan, 20141
Site 0087
Not yet recruiting
Local Institution - 0238
Milan, 20142
Site 0238
Not yet recruiting
Local Institution - 0091
Pavia, 27100
Site 0091
Not yet recruiting
Local Institution - 0088
Verona, 37126
Site 0088
Not yet recruiting

Other trials in Italy

Spain9 sites, 8 recruiting

Local Institution - 0242
A Coruña, 15006
Site 0242
Not yet recruiting
Local Institution - 0144
Jaén, 23007
Site 0144
Not yet recruiting
Local Institution - 0226
Jaén, 23007
Withdrawn
Local Institution - 0149
Jerez de la Frontera, 11407
Site 0149
Not yet recruiting
Local Institution - 0148
Madrid, 28041
Site 0148
Not yet recruiting
Local Institution - 0143
Majadahonda, Madrid, 28222
Site 0143
Not yet recruiting
Local Institution - 0150
Málaga, 29010
Site 0150
Not yet recruiting
Local Institution - 0147
Seville, Seville, 41013
Site 0147
Not yet recruiting
Local Institution - 0241
Valencia, 46009
Site 0241
Not yet recruiting

Other trials in Spain

Taiwan8 sites, 8 recruiting

Local Institution - 0227
Gaoxiongka, Taiwan, 807
Site 0227
Not yet recruiting
Local Institution - 0229
Kaohsiung City, Kaohsiung, 82445
Site 0229
Not yet recruiting
Local Institution - 0230
New Taipei City, New Taipei, 23561
Site 0230
Not yet recruiting
Local Institution - 0418
Taichung, 402
Site 0418
Not yet recruiting
China Medical University Hospital
Taichung, 404332
Chih-Yen Tu, Site 0216, 886-4-22052121ext.12
Recruiting
Local Institution - 0420
Tainan, 70428
Site 0420
Not yet recruiting
Local Institution - 0223
Taipei City, Taipei, 106
Site 0223
Not yet recruiting
Local Institution - 0221
Taoyuan City, Taoyuan, 33378
Site 0221
Not yet recruiting

Other trials in Taiwan

Argentina7 sites, 7 recruiting

Local Institution - 0086
Buenos Aires, C1122AAL
Site 0086
Not yet recruiting
Local Institution - 0432
Buenos Aires, C1199ABB
Site 0432
Not yet recruiting
Local Institution - 0085
Buenos Aires, C1280AEB
Site 0085
Not yet recruiting
Local Institution - 0078
Buenos Aires, C1426AGE
Site 0078
Not yet recruiting
Local Institution - 0151
Buenos Aires, C1426ANZ
Site 0151
Not yet recruiting
Local Institution - 0077
Mar del Plata, Buenos Aires, B7602CBM
Site 0077
Not yet recruiting
Local Institution - 0514
Río Cuarto, Córdoba Province, 5800
Site 0514
Not yet recruiting

Other trials in Argentina

India7 sites, 7 recruiting

Local Institution - 0444
Badsa, Haryana, 124105
Site 0444
Not yet recruiting
Local Institution - 0436
Belagavi, Karnataka, 590010
Site 0436
Not yet recruiting
Local Institution - 0222
Chennai, Tamil Nadu, 600035
Site 0222
Not yet recruiting
Local Institution - 0337
Gurgaon, Haryana, 122001
Site 0337
Not yet recruiting
Local Institution - 0233
Mohali, Punjab, 140901
Site 0233
Not yet recruiting
Local Institution - 0215
Pune, Maharashtra, 411013
Site 0215
Not yet recruiting
Local Institution - 0225
Vadodara, Gujarat, 361790
Site 0225
Not yet recruiting

Other trials in India

Australia6 sites, 6 recruiting

Local Institution - 0492
Adelaide, South Australia, 5000
Site 0492
Not yet recruiting
Local Institution - 0424
Camperdown, New South Wales, 2050
Site 0424
Not yet recruiting
Local Institution - 0447
Clayton, Victoria, 3168
Site 0447
Not yet recruiting
Local Institution - 0511
Greenslopes, Queensland, 4120
Site 0511
Not yet recruiting
Local Institution - 0437
Murdoch, Western Australia, 6150
Site 0437
Not yet recruiting
Local Institution - 0439
Westmead, New South Wales, 2145
Site 0439
Not yet recruiting

Other trials in Australia

Canada5 sites, 5 recruiting

Local Institution - 0059
Edmonton, Alberta, T6G1Z2
Site 0059
Not yet recruiting
Local Institution - 0058
Montreal, Quebec, H3T1E2
Site 0058
Not yet recruiting
Local Institution - 0057
Montreal, Quebec, H4A3J1
Site 0057
Not yet recruiting
Local Institution - 0040
Regina, Saskatchewan, S4T1A5
Site 0040
Not yet recruiting
Local Institution - 0056
Vancouver, British Columbia, V5Z4E6
Site 0056
Not yet recruiting

Other trials in Canada

Thailand2 sites, 2 recruiting

Local Institution - 0275
Bangkok, Bangkok, 10300
Site 0275
Not yet recruiting
Local Institution - 0263
Din Daeng, Bangkok, 10400
Site 0263
Not yet recruiting

Other trials in Thailand

About this study

Official title: A Phase III, Randomized, Open-label Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy as First-Line Therapy in Patients With EGFR-Mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer

Conditions: Non-Small Cell Lung Cancer
Being tested: Iza-bren, Osimertinib, Pemetrexed, Carboplatin, Cisplatin
Keywords: NSCLC, EGFR, First line, Izalontamab brengitecan, Osimertinib, ADC, IZABRIGHT-Lung02
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.

Iza-brenDrug
Also called BMS-986507, BL-B01D1, Izalontamab brengitecan
Specified dose on specified days
OsimertinibDrug
Specified dose on days
PemetrexedDrug
Specified dose on specified days
CarboplatinDrug
Specified dose on specified days
CisplatinDrug
Specified dose on specified days

Study groups in NCT07680790
Study group	Role	What they receive
Arm A	Experimental	Not described Receives: Drug: Iza-bren; Drug: Osimertinib
Arm B	Active comparator	Not described Receives: Drug: Osimertinib; Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin

What is being measured

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

Progression-Free Survival (PFS) using blinded independent central review (BICR) assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Measured: Up to approximately 3 years

Secondary outcomes (9)

Overall Survival (OS)
Measured: Up to approximately 5 years
PFS assessed by the investigator as per RECIST v1.1
Measured: Up to approximately 3 years
Second Progression-Free Survival (PFS2) as assessed by the Investigator
Measured: Up to approximately 5 years
Objective Response Rate (ORR) assessed by the BICR as per RECIST v1.1
Measured: Up to approximately 3 years
Objective Response Rate (ORR) assessed by the investigator as per RECIST v1.1
Measured: Up to approximately 3 years
Disease Control Rate (DCR) assessed by the BICR as per RECIST v1.1
Measured: Up to approximately 3 years
Disease Control Rate (DCR) assessed by the investigator as per RECIST v1.1
Measured: Up to approximately 3 years
Duration of Response (DOR) assessed by the BICR as per RECIST v1.1
Measured: Up to approximately 3 years
Duration of Response (DOR) assessed by the investigator as per RECIST v1.1
Measured: Up to approximately 3 years

Timeline

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

8 Sep 202630 Dec 2031

First posted2 Jul 2026
Study start8 Sep 2026
Primary completion30 Dec 2031 (estimated)
Study completion30 Dec 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 850 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07680790
Sponsor's protocol ID: CA244-0020
Other IDs: 2026-526486-21, U1111-1338-8955
Status last verified: Sep 2026
First submitted: 26 Jun 2026
Last updated: 8 Oct 2026
Results posted: No
Data monitoring committee: Yes
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

Interested in taking part?

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286

Clinical.Trials@bms.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Recruiting
Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy
Lung Neoplasm
Active, not recruitingPhase 2
1st Line Durvalumab in PS 2 NSCLC Patients
NSCLC Stage IV, NSCLC Stage IIIB
Active, not recruitingPhase 2
Multimodality Treatment in Stage III Non-small Cell Lung Cancer (NSCLC)
Non-small Cell Lung Cancer, NSCLC
RecruitingPhase 3
Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])
Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Squamous Carcinoma
Recruiting
Quality of Life Intervention to Inform Patient Decision-Making in Early-Stage Lung Cancer
Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8

All Non-Small Cell Lung Cancer trials