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New drug cocktail aims to outsmart lung cancer

NCT ID NCT07005102

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding an experimental drug called telisotuzumab adizutecan to the standard targeted therapy osimertinib can improve outcomes for people with advanced EGFR-mutated non-small cell lung cancer. About 854 adults will be enrolled worldwide. The trial has two stages: first to find the best dose, then to compare the combo against standard care (osimertinib plus chemotherapy). The main goals are to see if the combo shrinks tumors and delays cancer growth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Telisotuzumab adizutecan (an investigational antibody-drug conjugate) combined with osimertinib (a targeted therapy)
What this could lead to
If successful, this combination could offer a more effective first-line treatment option for people with a specific type of advanced lung cancer, potentially delaying disease progression.
What could go wrong
This is an early-to-mid stage trial (phase 2/3) testing an investigational drug. The combination may cause more side effects than standard care, and it's not yet proven to be better or safe long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 854 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Nov 2036

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 1. 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. 2. Successfully treated nonmelanoma skin cancer. 3. Localized carcinoma in situ of the cervix. 4. Breast Cancer; lobular carcinoma in situ or ductal carcinoma in situ that is considered completely cured.

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Conditions

The condition(s) this trial relates to.

neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-squamous non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    51 sites in 13 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AZ-Delta. /ID# 275753

    RECRUITING

    Roeselare, West-Vlaanderen, 8800, Belgium

  • Asan Medical Center /ID# 275600

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 05505, South Korea

  • Austin Health /ID# 275505

    RECRUITING

    Heidelberg, Victoria, 3084, Australia

  • Azienda Ospedaliero Universitaria San Luigi Gonzaga /ID# 275215

    RECRUITING

    Orbassano, Torino, 10043, Italy

  • CHU de Liege /ID# 277971

    RECRUITING

    Liège, 4000, Belgium

  • Chungbuk National University Hospital /ID# 275768

    RECRUITING

    Cheongju-si, North Chungcheong, 28644, South Korea

  • Hospital Clinic de Barcelona /ID# 275476

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital Cuf Porto /ID# 275395

    RECRUITING

    Porto, 4100-180, Portugal

  • Hospital General Universitario Gregorio Maranon /ID# 275475

    RECRUITING

    Madrid, 28007, Spain

  • Hospital Universitario 12 de Octubre /ID# 277698

    RECRUITING

    Madrid, 28041, Spain

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

    RECRUITING

    Rome, Roma, 00144, Italy

  • Inje University Haeundae Paik Hospital /ID# 275388

    RECRUITING

    Busan, Busan Gwang Yeogsi, 48108, South Korea

  • Instituto Valenciano de Oncología /ID# 275471

    RECRUITING

    Valencia, 46009, Spain

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

    RECRUITING

    Chandler, Arizona, 85224, United States

  • Jessa Ziekenhuis - Campus Virga Jesse /ID# 275585

    RECRUITING

    Hasselt, Limburg, 3500, Belgium

  • Juntendo University Hospital /ID# 276424

    RECRUITING

    Bunkyo-ku, Tokyo, 113-8431, Japan

  • Kaiser Permanente Moanalua Medical Center /ID# 275942

    RECRUITING

    Honolulu, Hawaii, 96819, United States

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

    RECRUITING

    Kaohsiung City, 807, Taiwan

  • Liverpool Hospital /ID# 276304

    RECRUITING

    Liverpool, New South Wales, 2170, Australia

  • Mid Florida Hematology And Oncology Center /ID# 275278

    RECRUITING

    Orange City, Florida, 32763, United States

  • National Cancer Center Hospital /ID# 275678

    RECRUITING

    Chuo-Ku, Tokyo, 104-0045, Japan

  • National Cancer Centre Singapore /ID# 275986

    RECRUITING

    Singapore, Central Singapore, 169611, Singapore

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

    RECRUITING

    Taipei, 106, Taiwan

  • National University Hospital /ID# 275988

    RECRUITING

    Singapore, 119074, Singapore

  • Nho - Revive Research Institute /ID# 276115

    RECRUITING

    Lincoln, Nebraska, 68506, United States

  • Niigata University Medical and Dental Hospital /ID# 275685

    RECRUITING

    Niigata, Niigata, 951-8520, Japan

  • Osaka Medical And Pharmaceutical University Hospital /ID# 275684

    RECRUITING

    Takatsuki, Osaka, 569-8686, Japan

  • Princess Margaret Cancer Centre /ID# 274845

    COMPLETED

    Toronto, Ontario, M5G 2M9, Canada

  • Rabin Medical Center. /ID# 274540

    RECRUITING

    Petah Tikva, Central District, 4941492, Israel

  • Rambam Health Care Campus- Haifa /ID# 274542

    RECRUITING

    Haifa, 3109601, Israel

  • Renown Regional Medical Center /ID# 276049

    RECRUITING

    Reno, Nevada, 89502, United States

  • Samsung Medical Center /ID# 278083

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Shizuoka Cancer Center /ID# 278082

    RECRUITING

    Sunto-gun, Shizuoka, 411-8777, Japan

  • St John Of God Murdoch Hospital /ID# 275700

    RECRUITING

    Murdoch, Western Australia, 6150, Australia

  • Taipei Veterans General Hospital /ID# 275292

    RECRUITING

    Taipei, 112, Taiwan

  • Texas Oncology - Palestine Cancer Center /ID# 276034

    RECRUITING

    Palestine, Texas, 75801, United States

  • Texas Oncology - South Austin /ID# 276033

    RECRUITING

    Austin, Texas, 78745, United States

  • The Chaim Sheba Medical Center /ID# 274541

    RECRUITING

    Ramat Gan, Tel Aviv, 5265601, Israel

  • The Iowa Clinic /ID# 276020

    COMPLETED

    West Des Moines, Iowa, 50266, United States

  • The Ottawa Hospital - General Campus /ID# 275611

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • The Queen Elizabeth Hospital /ID# 275719

    RECRUITING

    Woodville, South Australia, 5011, Australia

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

    RECRUITING

    Houston, Texas, 77030, United States

  • USC Norris Comprehensive Cancer Center /ID# 275343

    RECRUITING

    Los Angeles, California, 90033, United States

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

    RECRUITING

    Braga, 4710-243, Portugal

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

    RECRUITING

    Porto, 4099-003, Portugal

  • Union Hospital Tongji Medical College /ID# 278711

    RECRUITING

    Wuhan, Hubei, 430048, China

  • Universitair Ziekenhuis Leuven /ID# 275586

    RECRUITING

    Leuven, Vlaams-Brabant, 3000, Belgium

  • University Colorado Cancer Center /ID# 275382

    RECRUITING

    Aurora, Colorado, 80045-2517, United States

  • University of Washington Medical Center /ID# 275866

    RECRUITING

    Seattle, Washington, 98195, United States

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

    RECRUITING

    Newport Beach, California, 92663, United States

  • Virginia Cancer Specialists - Fairfax /ID# 275071

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Yokohama Municipal Citizen's Hospital /ID# 275682

    RECRUITING

    Yokohama, Kanagawa, 221-0855, Japan

  • Yonsei University Health System Severance Hospital /ID# 275384

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 03722, South Korea

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