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Non-Squamous Non-Small Cell Lung CancerPhase 2/3NCT07005102

A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

A Phase 2/3 study testing Telisotuzumab Adizutecan, Osimertinib (Osi) and Cisplatin in people with Non-Squamous Non-Small Cell Lung Cancer and c-MET, run by AbbVie at 65 sites in 13 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

Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to assess adverse events and change in disease activity "when telisotuzumab adizutecan is given in combination with a fixed dose of osimertinib (Osi)or standard of care… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Telisotuzumab Adizutecan, Osimertinib (Osi) and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
854 participants
Where
65 sitesin 13 countries
Study dates
3 Aug 2025to Nov 2036
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

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

  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 during the screening period and prior to dosing of study treatment on Cycle 1 Day 1.
  • Must consent to provide recently obtained formalin-fixed, paraffin-embedded (FFPE) tumor tissue (ideally collected during or after locally advanced or metastatic diagnosis) or archived tissue during screening for c-Met immunohistochemistry (IHC) testing and study stratification. c-Met IHC results are required prior to randomization.
  • Must have at least one non-irradiated measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. If only one measurable lesion exists, it is acceptable to be used (as a target lesion) as long as it has not been previously irradiated and as long as it has not been biopsied within 14 days of the baseline tumor assessment scans.
  • Any toxicities from prior systemic anti-cancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Grade 1 or baseline level (except for alopecia [any grade] or Grade <= 2 peripheral neuropathy).
  • Should not have any major, life-threatening conditions and life expectancy as determined by the investigator should be at least 3 months.
  • No prior estimated glomerular filtration rate (EGFR) tyrosine kinase inhibitor (TKI) in the locally advanced and/or metastatic setting (except for when it is allowed on study prior to C1D1). Participants treated with prior EGFR TKI in the adjuvant setting are allowed to enroll provided that >= 126 months (since last dose of e.g., adjuvant osimertinib) have passed before Cycle 1, Day 1.
  • Diagnosis of histologically or cytologically confirmed metastatic/locally advanced non-squamous NSCLC with documented classical EGFR mutation (Exon 19 Del or Exon 21 L858R) either alone or in combination with other EGFR mutations as detected by an Food and Drug Administration (FDA)-approved or other validated test in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory (sites in the US) or an accredited Laboratory (sites outside of the US) in accordance with site standard of care. A copy of the test report documenting the EGFR mutation must be available in the participant records.

Who cannot join

  • History of interstitial lung disease (ILD), pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT) scan.
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
  • Participants has leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation.
  • History of any malignancy other than disease under study except for
  • Malignancy treated with curative intent and with no known active disease present for 2 years before the first dose of study treatment and felt to be at low risk for recurrence by investigator.
  • Successfully treated nonmelanoma skin cancer.
  • Localized carcinoma in situ of the cervix.
  • Breast Cancer; lobular carcinoma in situ or ductal carcinoma in situ that is considered completely cured.

Trial locations and contacts

65 sites in 13 countries. Contact the study team or a site near you to ask about taking part.

ABBVIE CALL CENTER contact

844-663-3742

abbvieclinicaltrials@abbvie.com

65 sites in 13 countries

United States18 sites, 17 recruiting

  • University Colorado Cancer Center /ID# 275382

    Aurora, Colorado, 80045-2517

    Recruiting

  • Texas Oncology - South Austin /ID# 276033

    Austin, Texas, 78745

    Recruiting

  • Ironwood Cancer and Research Centers - Chandler /ID# 275443

    Chandler, Arizona, 85224

    Recruiting

  • City of Hope National Medical Center /ID# 282241

    Duarte, California, 91010

    Recruiting

  • Virginia Cancer Specialists - Fairfax /ID# 275071

    Fairfax, Virginia, 22031

    Recruiting

  • Kaiser Permanente Moanalua Medical Center /ID# 275942

    Honolulu, Hawaii, 96819

    Recruiting

  • The University of Texas MD Anderson Cancer Center /ID# 275107

    Houston, Texas, 77030

    Recruiting

  • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 284734

    Irvine, California, 92618

    Recruiting

  • Nho - Revive Research Institute /ID# 276115

    Lincoln, Nebraska, 68506

    Recruiting

  • USC Norris Comprehensive Cancer Center /ID# 275343

    Los Angeles, California, 90033

    Recruiting

  • Usc Norris Oncology/Hematology Treatment Center /ID# 278673

    Newport Beach, California, 92663

    Recruiting

  • Mid Florida Hematology And Oncology Center /ID# 275278

    Orange City, Florida, 32763

    Recruiting

  • Texas Oncology - Palestine Cancer Center /ID# 276034

    Palestine, Texas, 75801

    Recruiting

  • Renown Regional Medical Center /ID# 276049

    Reno, Nevada, 89502

    Recruiting

  • UCLA - Santa Monica /ID# 276816

    Santa Monica, California, 90404

    Recruiting

  • University of Washington Medical Center /ID# 275866

    Seattle, Washington, 98195

    Recruiting

  • City Of Hope - Upland /ID# 284650

    Upland, California, 91786

    Recruiting

  • The Iowa Clinic /ID# 276020

    West Des Moines, Iowa, 50266

    Completed

Other trials in United States

China7 sites, 7 recruiting

  • Cancer Hospital - Chinese Academy of Medical Sciences /ID# 275631

    Beijing, Beijing Municipality, 100021

    Recruiting

  • West China Hospital of Sichuan University /ID# 274946

    Chengdu, Sichuan, 610041

    Recruiting

  • Fujian Province Cancer Hospital /ID# 274913

    Fuzhou, Fujian, 350014

    Recruiting

  • The First Affiliated Hospital Of Guangzhou Medical University /ID# 274914

    Guangzhou, Guangdong, 510163

    Recruiting

  • The First affiliated hospital of Nanchang University /ID# 275257

    Nanchang, Jiangxi, 330006

    Recruiting

  • Shanghai Chest Hospital /ID# 275273

    Shanghai, Shanghai Municipality, 200030

    Recruiting

  • Union Hospital Tongji Medical College /ID# 278711

    Wuhan, Hubei, 430048

    Recruiting

Other trials in China

Japan6 sites, 6 recruiting

  • Juntendo University Hospital /ID# 276424

    Bunkyo-ku, Tokyo, 113-8431

    Recruiting

  • National Cancer Center Hospital /ID# 275678

    Chuo-Ku, Tokyo, 104-0045

    Recruiting

  • Niigata University Medical and Dental Hospital /ID# 275685

    Niigata, Niigata, 951-8520

    Recruiting

  • Shizuoka Cancer Center /ID# 278082

    Sunto-gun, Shizuoka, 411-8777

    Recruiting

  • Osaka Medical And Pharmaceutical University Hospital /ID# 275684

    Takatsuki, Osaka, 569-8686

    Recruiting

  • Yokohama Municipal Citizen's Hospital /ID# 275682

    Yokohama, Kanagawa, 221-0855

    Recruiting

Other trials in Japan

South Korea5 sites, 5 recruiting

  • Inje University Haeundae Paik Hospital /ID# 275388

    Busan, Busan Gwang Yeogsi, 48108

    Recruiting

  • Chungbuk National University Hospital /ID# 275768

    Cheongju-si, North Chungcheong, 28644

    Recruiting

  • Yonsei University Health System Severance Hospital /ID# 275384

    Seoul, Seoul Teugbyeolsi, 03722

    Recruiting

  • Asan Medical Center /ID# 275600

    Seoul, Seoul Teugbyeolsi, 05505

    Recruiting

  • Samsung Medical Center /ID# 278083

    Seoul, Seoul Teugbyeolsi, 06351

    Recruiting

Other trials in South Korea

Australia4 sites, 4 recruiting

  • Austin Health /ID# 275505

    Heidelberg, Victoria, 3084

    Recruiting

  • Liverpool Hospital /ID# 276304

    Liverpool, New South Wales, 2170

    Recruiting

  • St John of God Murdoch Hospital /ID# 275700

    Murdoch, Western Australia, 6150

    Recruiting

  • The Queen Elizabeth Hospital /ID# 275719

    Woodville South, South Australia, 5011

    Recruiting

Other trials in Australia

Belgium4 sites, 4 recruiting

  • Jessa Ziekenhuis - Campus Virga Jesse /ID# 275585

    Hasselt, Limburg, 3500

    Recruiting

  • Universitair Ziekenhuis Leuven /ID# 275586

    Leuven, Vlaams-Brabant, 3000

    Recruiting

  • CHU de Liege /ID# 277971

    Liège, 4000

    Recruiting

  • AZ-Delta. /ID# 275753

    Roeselare, West-Vlaanderen, 8800

    Recruiting

Other trials in Belgium

Italy4 sites, 4 recruiting

  • Azienda Ospedaliero Universitaria San Luigi Gonzaga /ID# 275215

    Orbassano, Torino, 10043

    Recruiting

  • Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 277808

    Perugia, 06156

    Recruiting

  • Fondazione Policlinico Universitario Campus Bio-Medico /ID# 280103

    Roma, 00128

    Recruiting

  • IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 274948

    Rome, Roma, 00144

    Recruiting

Other trials in Italy

Spain4 sites, 4 recruiting

  • Hospital Clinic de Barcelona /ID# 275476

    Barcelona, 08036

    Recruiting

  • Hospital General Universitario Gregorio Maranon /ID# 275475

    Madrid, 28007

    Recruiting

  • Hospital Universitario 12 de Octubre /ID# 277698

    Madrid, 28041

    Recruiting

  • Instituto Valenciano de Oncologia /ID# 275471

    Valencia, 46009

    Recruiting

Other trials in Spain

Israel3 sites, 3 recruiting

  • Rambam Health Care Campus- Haifa /ID# 274542

    Haifa, 3109601

    Recruiting

  • Rabin Medical Center. /ID# 274540

    Petah Tikva, Central District, 4941492

    Recruiting

  • The Chaim Sheba Medical Center /ID# 274541

    Ramat Gan, Tel Aviv, 5265601

    Recruiting

Other trials in Israel

Portugal3 sites, 3 recruiting

  • Unidade Local de Saude de Braga, EPE /ID# 275394

    Braga, 4710-243

    Recruiting

  • Unidade Local de Saude de Santo Antonio /ID# 275387

    Porto, 4099-003

    Recruiting

  • Hospital Cuf Porto /ID# 275395

    Porto, 4100-180

    Recruiting

Other trials in Portugal

Taiwan3 sites, 3 recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 275293

    Kaohsiung City, 807

    Recruiting

  • National Taiwan University Cancer Center (Ntucc) /ID# 275291

    Taipei, 106

    Recruiting

  • Taipei Veterans General Hospital /ID# 275292

    Taipei, 112

    Recruiting

Other trials in Taiwan

Canada2 sites, 1 recruiting

  • The Ottawa Hospital - General Campus /ID# 275611

    Ottawa, Ontario, K1H 8L6

    Recruiting

  • Princess Margaret Cancer Centre /ID# 274845

    Toronto, Ontario, M5G 2M9

    Active, not recruiting

Other trials in Canada

Singapore2 sites, 2 recruiting

  • National Cancer Centre Singapore /ID# 275986

    Singapore, Central Singapore, 169611

    Recruiting

  • National University Hospital /ID# 275988

    Singapore, 119074

    Recruiting

Other trials in Singapore

About this study

Official title: A Phase 2/3 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to assess adverse events and change in disease activity "when telisotuzumab adizutecan is given in combination with a fixed dose of osimertinib (Osi)or standard of care (Osi plus platinum/pemetrexed chemotherapy).

Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. Osi is a drug approved for the treatment of NSCLC. This study will be divided into two stages, in the first stage participants will receive increasing doses of telisotuzumab adizutecan with Osi. Participants will then be randomized into 4 groups called treatment arms where 3 groups will receive 1 of 3 doses of telisotuzumab adizutecan from from the dose escalation phase with Osi, or standard of care (Osi plus chemotherapy). In the second stage participants will receive the optimal dose of telisotuzumab adizutecan, from the previous stage, with Osi, or SOC. Approximately 854 adult participants with 1L estimated glomerular filtration rate (EGFR) mut (mutated) not sufficient quantity (NSq) NSCLC will be enrolled in the study in 200 sites worldwide.

Read more

In Stage 1, during dose escalation participants will receive increasing intravenous (IV) doses of telisotuzumab adizutecan with oral Osi tablets. participants will receive 1 of 3 doses of telisotuzumab adizutecan with Osi, or standard of care (Osi plus chemotherapy). In stage 2 participants will receive the optimal dose of IV telisotuzumab adizutecanin with oral Osi tablet, or SOC. The study will run for a duration of approximately 76 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Being tested
Standard of Care, Telisotuzumab Adizutecan, Osimertinib (Osi), Cisplatin, Carboplatin
Keywords
Non-Squamous Non-Small Cell Lung Cancer, Telisotuzumab Adizutecan, Osimertinib, Cisplatin, Carboplatin, Pemetrexed, ABBV-400, Stand of Care, Cancer, Chemotherapy, Platinum Chemotherapy
Medical subject headings
Neoplasms

What participants receive

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

  • Standard of CareDrug

    Standard of Care

  • Telisotuzumab AdizutecanDrug

    Intravenous (IV)

  • Osimertinib (Osi)Drug

    Oral

  • CisplatinDrug

    IV

  • CarboplatinDrug

    IV

  • PemetrexedDrug

    IV

Study groups in NCT07005102
Study groupRoleWhat they receive
Stage 1: Escalation Telisotuzumab Adizutecan + OsimertinibExperimentalParticipants will receive increasing doses of telisotuzumab adizutecan with osimertinib (Osi), as part of the approximately 76 month study duration.
Receives: Drug: Telisotuzumab Adizutecan; Drug: Osimertinib (Osi)
Stage 1: Expansion Telisotuzumab Adizutecan Dose A + OsiExperimentalParticipants will receive telisotuzumab adizutecan dose A with Osi, as part of the approximately 76 month study duration.
Receives: Drug: Telisotuzumab Adizutecan; Drug: Osimertinib (Osi)
Stage 1: Expansion Telisotuzumab Adizutecan Dose B + OsiExperimentalParticipants will receive telisotuzumab adizutecan dose B with Osi, as part of the approximately 76 month study duration.
Receives: Drug: Telisotuzumab Adizutecan; Drug: Osimertinib (Osi)
Stage 1: Expansion Telisotuzumab Adizutecan Dose C + OsiExperimentalParticipants will receive telisotuzumab adizutecan dose C with Osi, as part of the approximately 76 month study duration.
Receives: Drug: Telisotuzumab Adizutecan; Drug: Osimertinib (Osi)
Stage 1: Expansion Osi + Chemotherapy + PemetrexedExperimentalParticipants will receive Osi with chemotherapy followed by Osi with pemetrexed, as part of the approximately 76 month study duration.
Receives: Drug: Osimertinib (Osi); Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed
Stage 2: Standared of Care (SOC)ExperimentalParticipants will receive SOC, as part of the approximately 76 month study duration.
Receives: Drug: Standard of Care; Drug: Osimertinib (Osi)
Stage 2: Optimized Telisotuzumab Adizutecan + OsiExperimentalParticipants will receive the optimized dose of telisotuzumab adizutecan with Osi, as part of the approximately 76 month study duration.
Receives: Drug: Telisotuzumab Adizutecan; Drug: Osimertinib (Osi)

What is being measured

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

  1. Stage 1: Objective Response (OR) Based on Blinded Independent Central Review (BICR) Assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    OR is defined as confirmed complete response (CR) or confirmed partial response (PR) per BICR based on RECIST version 1.1.

    Measured: Up to Approximately 76 Months

  2. Stage 2: Progression-free survival (PFS) based on BICR assessment per RECIST version 1.1.

    PFS is defined as the time from the participant's randomization date to the first occurrence of radiographic progression per BICR based on RECIST version 1.1 or death from any cause, whichever occurs earlier.

    Measured: Up to Approximately 76 Months

  3. Number of Participants with Adverse Events (AEs)

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

    Measured: Up to Approximately 76 Months

Secondary outcomes (11)

  1. Stage 1: PFS based on BICR assessment per RECIST version 1.1.

    PFS is defined as the time from the participant's randomization date to the first occurrence of radiographic progression per BICR based on RECIST version 1.1 or death from any cause, whichever occurs earlier.

    Measured: Up to Approximately 76 Months

  2. Stage 1: Duration of response (DoR) based on BICR assessment per RECIST version 1.1.

    DOR is defined as the time from the first documented CR or PR per BICR to the first occurrence of radiographic progression per RECIST version 1.1 or death from any cause, whichever occurs first. DOR is defined for participants with confirmed CR/PR.

    Measured: Up to Approximately 76 Months

  3. Stage 1: Disease control rate (DC) based on BICR assessment per RECIST version 1.1.

    DC is defined as best overall response of confirmed CR or confirmed PR, or stable disease (SD) for at least 12 weeks following randomization date based on RECIST version 1.1, as determined by the BICR.

    Measured: Up to Approximately 76 Months

  4. Stage 1: Overall Survival

    OS is defined as the time from participant's randomization date to the event of death from any cause.

    Measured: Up to Approximately 76 Months

  5. Stage 2: Overall Survival

    OS is defined as the time from participant's randomization date to the event of death from any cause.

    Measured: Up to Approximately 76 Months

  6. Stage 2: OR based on BICR assessment per RECIST version 1.1.

    OR is defined as confirmed CR or confirmed PR per BICR based on RECIST version 1.1.

    Measured: Up to Approximately 76 Months

  7. Stage 2: DoR based on BICR assessment per RECIST version 1.1.

    DOR is defined as the time from the first documented CR or PR per BICR to the first occurrence of radiographic progression per RECIST version 1.1 or death from any cause, whichever occurs first. DOR is defined for participants with confirmed CR/PR.

    Measured: Up to Approximately 76 Months

  8. Stage 2: DC based on BICR assessment per RECIST version 1.1.

    DC is defined as best overall response of confirmed CR or confirmed PR, or SD for at least 12 weeks following randomization date based on RECIST version 1.1, as determined by the BICR.

    Measured: Up to Approximately 76 Months

  9. Stage 2: Change from baseline at Week 12 in physical functioning as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).

    The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much).

    Measured: Up to Approximately 76 Months

  10. Stage 2: Change from baseline at Week 12 in key lung cancer symptoms as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 (EORTC QLQ-LC13)

    The EORTC QLQ-LC13 is a lung cancer specific module and consists of 13 questions assessing lung cancer-associated symptoms and treatment-related effects, including one multiple-item scale to assess dyspnea and a series of single items assessing coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain, and pain medication. Each item is assessed on a Likert scale from 1 (not at all) to 4 (very much).

    Measured: Up to Approximately 76 Months

  11. Stage 2: Change from baseline at Week 12 in GHS/QoL as measured by the EORTC QLQ-C30.

    The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much).

    Measured: Up to Approximately 76 Months

Timeline

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

  1. First posted5 Jun 2025
  2. Study start3 Aug 2025
  3. Primary completionNov 2036 (estimated)
  4. Study completionNov 2036 (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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
854 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07005102
Sponsor's protocol ID
M25-287
Other IDs
2024-518586-10
Status last verified
Oct 2026
First submitted
27 May 2025
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Telisotuzumab Adizutecan, Osimertinib (Osi) and Cisplatin in people with Non-Squamous Non-Small Cell Lung Cancer and c-MET, run by AbbVie at 65 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, China, Japan, South Korea, Australia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stage 1: Objective Response (OR) Based on Blinded Independent Central Review (BICR) Assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (time frame: Up to Approximately 76 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07005102.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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