Telisotuzumab + Osimertinib for Non-Small Cell Lung Cancer

Recruiting at 36 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: AbbVie

Must be taking: Osimertinib

Disqualifiers: Interstitial lung disease, Pneumonitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

694 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new treatment options for individuals with non-small cell lung cancer (NSCLC), a type of lung cancer characterized by uncontrollable growth of abnormal cells in the lungs. Researchers aim to evaluate the effectiveness of a new drug, telisotuzumab adizutecan, when combined with an existing drug, osimertinib, compared to using osimertinib or standard treatments alone. Participants will receive various combinations of these drugs to determine the optimal dose with minimal side effects. This trial may suit those with NSCLC who have measurable disease and no severe health conditions. Participants must visit a clinic regularly for check-ups and monitoring. As a Phase 2 trial, this study focuses on assessing the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant research.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of telisotuzumab adizutecan and osimertinib has a manageable safety profile for patients with non-small cell lung cancer. Most side effects can be controlled with proper care. Previous studies suggest that while side effects occur, they usually aren't severe enough to stop treatment.

Osimertinib, when used alone, is already approved for treating non-small cell lung cancer and has a well-known safety record. Doctors are familiar with its side effects, providing reassurance about its safety in combination.

In summary, existing studies indicate that the combination of telisotuzumab adizutecan and osimertinib is generally well-tolerated. Regular check-ups and tests help monitor side effects, ensuring the treatment remains as safe as possible. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Telisotuzumab Adizutecan combined with Osimertinib for non-small cell lung cancer because it offers a unique approach compared to standard treatments like chemotherapy and immunotherapy. Telisotuzumab Adizutecan is an antibody-drug conjugate designed to specifically target cancer cells, potentially leading to more precise and effective cancer cell destruction with fewer side effects. This treatment also pairs with Osimertinib, a targeted therapy known for its effectiveness in treating certain lung cancers with specific genetic mutations. Together, they promise a powerful one-two punch by combining targeted cancer cell delivery with the genetic targeting capabilities of Osimertinib.

What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?

Research has shown that combining telisotuzumab adizutecan with osimertinib may be promising for treating non-small cell lung cancer (NSCLC). In this trial, participants will receive different doses of telisotuzumab adizutecan with osimertinib in various treatment arms. This combination appears especially effective for patients whose cancer has high levels of a protein called c-Met. The side effects of this treatment are considered manageable, meaning they are acceptable when weighed against the benefits. Osimertinib alone, which participants in some arms of this trial will receive, is already approved and works well for NSCLC with certain genetic changes. Overall, early research suggests that adding telisotuzumab adizutecan could enhance the treatment's effectiveness, offering hope for better outcomes in challenging cases of lung cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults with advanced, inoperable or metastatic EGFR-mutated non-squamous NSCLC are eligible for this trial. Participants must not have received prior treatment for their lung cancer and should be able to attend regular study visits at a participating institution.

Inclusion Criteria

Must consent to provide recently obtained formalin-fixed, paraffin-embedded (FFPE) tumor tissue for c-Met immunohistochemistry (IHC) testing and study stratification

Should not have any major, life-threatening conditions and life expectancy as determined by the investigator should be at least 3 months

I have at least one tumor that can be measured and has not been treated with radiation.

Exclusion Criteria

I have cancer that has spread to the lining of my brain or spinal cord, or I have untreated spinal cord compression.

I have had lung conditions that needed steroid treatment.

I had cancer before, but it was treated successfully and hasn't come back in 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive increasing intravenous doses of telisotuzumab adizutecan with oral osimertinib tablets

Duration not specified

Regular visits at approved institutions

Dose Optimization

Participants receive osimertinib alone or with one of three optimized doses of telisotuzumab adizutecan

Duration not specified

Regular visits at approved institutions

Stage 2 Treatment

Participants receive the optimal dose of telisotuzumab adizutecan with osimertinib or standard of care

Duration not specified

Regular visits at approved institutions

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 76 months

What Are the Treatments Tested in This Trial?

Interventions

• Osimertinib
• Telisotuzumab Adizutecan

Trial Overview The trial is testing the safety and disease response of Telisotuzumab Adizutecan combined with Osimertinib compared to Osimertinib alone or standard care. It involves two stages: dose escalation of Telisotuzumab Adizutecan with Osimertinib, followed by randomization into treatment arms.

How Is the Trial Designed?

Group I: Stage 2: Telisotuzumab Adizutecan Optimized with Osi Experimental Treatment 2 Interventions

Participants will receive the optimized dose of telisotuzumab adizutecan with Osi, as part of the approximately 76 month study duration.

Group II: Stage 2: Standared of Care (SOC) Osi Experimental Treatment 1 Intervention

Participants will receive Osi, as part of the approximately 76 month study duration.

Group III: Stage 1: Expansion Telisotuzumab Adizutecan Dose C with Osi Experimental Treatment 2 Interventions

Participants will receive telisotuzumab adizutecan dose C with Osi, as part of the approximately 76 month study duration.

Group IV: Stage 1: Expansion Telisotuzumab Adizutecan Dose B with Osi Experimental Treatment 2 Interventions

Participants will receive telisotuzumab adizutecan dose B with Osi, as part of the approximately 76 month study duration.

Group V: Stage 1: Expansion Telisotuzumab Adizutecan Dose A with Osi Experimental Treatment 2 Interventions

Participants will receive telisotuzumab adizutecan dose A with Osi, as part of the approximately 76 month study duration.

Group VI: Stage 1: Expansion Osi Experimental Treatment 1 Intervention

Participants will receive Osi, as part of the approximately 76 month study duration.

Group VII: Stage 1: Escalation Telisotuzumab Adizutecan with Osimertinib Experimental Treatment 2 Interventions

Participants will receive increasing doses of telisotuzumab adizutecan with osimertinib (Osi), as part of the approximately 76 month study duration.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07005102

NCT07005102 | A Study to Assess Adverse Events ... 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 ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.8512

Telisotuzumab adizutecan (ABBV-400; Temab-A), a c-Met ... Temab-A has a manageable safety profile with promising clinical activity in pts with 3L+ NSQ EGFR MT NSCLC, meriting further investigation.

3. asco.org asco.org/abstracts-presentations/ABSTRACT482780

Telisotuzumab adizutecan (ABBV-400; Temab-A), a c-Met ... Background: c-Met protein (also known as MET protein) expression is increased in NSCLC and is a negative prognostic indicator. Temab-A is an ADC comprising the ...

4. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M25-287

A Study to Assess Adverse Events, Change in Disease ... A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39805351/

Results from a phase Ib study of telisotuzumab vedotin in ... Teliso-V plus osimertinib had promising activity and a manageable safety profile in patients with c-Met protein-overexpressing, EGFR-mutated non-squamous NSCLC ...

6. cancer.gov cancer.gov/clinicaltrials/NCI-2025-06505

A Study to Assess Adverse Events, Change in Disease ... 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 ...