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Non-Small Cell Lung CancerPhase 3NCT06093503

Study of Intravenous Telisotuzumab Vedotin in Combination Osimertinib or Standard of Care Chemotherapy to Assess Change in Disease Activity in Adult Participants With Non-Small Cell Lung Cancer That Has a Mutation in the Epidermal Growth Factor Receptor Gene and That Overexpresses the c-Met Protein

A Phase 3 study testing Telisotuzumab Vedotin, Osimertinib and Cisplatin in people with Non-Small Cell Lung Cancer, run by AbbVie.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. 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?
Telisotuzumab Vedotin, Osimertinib and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
31 May 2024to 11 Apr 2028
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Must have metastatic/locally advanced non-squamous NSCLC with documented epidermal growth factor receptor (EGFR) mutation del19 or L858R, with or without T790M mutation, and no identified EGFR mutations known to confer resistance to osimertinib (for instance C797S).
  • Must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory.
  • Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
  • Must have measurable disease per response evaluation criteria in solid tumors (RECIST) version 1.1.
  • Must have received one prior regimen in the metastatic setting, consisting of a third generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKi) (for instance, osimertinib). Participant must have had one disease progression while on this third generation EGFR TKi. Prior-rechallenge with a third generation EGFR TKi is not allowed. Treatment with a first or second generation EGFR TKi immediately prior to the third generation EGFR TKi will not count as one prior regimen. Those who have received a third generation EGFR TKi as adjuvant therapy, and have progressed within 6 months of the last dose of treatment will be eligible (i.e., considered as having received a third generation EGFR TKi in the metastatic setting).
  • Must be considered appropriate for platinum therapy based on the assessment of the treating physician.
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  • Participants with metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy) is provided and:
  • There is no evidence of progression of CNS metastases at least 4 weeks after definitive therapy.
  • Participant is asymptomatic and off or on a stable or reducing dose of systemic steroids and/or anticonvulsants for at least 4 weeks prior to first dose of telisotuzumab vedotin.
  • There is no leptomeningeal seeding of the disease.
  • History of prior radiation pneumonitis in the radiation field (fibrosis) is permitted.

Who cannot join

  • Have adenosquamous histology, nor sarcomatoid features.
  • Alterations in ALK, ROS1, or BRAF that predict sensitivity to targeted therapies.
  • Have small-cell histology.
  • Have received prior chemotherapy in the metastatic setting. For the enrollment criterion, if a subject has received one to two cycles of platinum-based chemotherapy prior to starting a third generation EGFR TKi, without progression and while awaiting EGFR status results, it will not be counted as "prior platinum therapy." Those who have received platinum-based chemotherapy as adjuvant therapy, and have progressed within 6 months of the last dose will be counted as having received a prior platinum therapy in the metastatic setting.
  • Have a history of other malignancies except those listed in the protocol.
  • Have a history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
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  • Have unresolved adverse events (AEs) >= Grade 2 from prior anticancer therapy, except for alopecia or anemia.
  • Have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
  • Have clinically significant condition(s) including but not limited to those listed in the protocol.
  • Clinically significant liver disease, including hepatitis, current alcohol abuse, or cirrhosis.
  • Grade >= 2 edema or lymphedema.
  • Grade >= 2 ascites or pleural effusion.
  • Grade >= 2 neuropathy.
  • Active uncontrolled bacterial or viral infection.
  • Active corneal disorder.

About this study

Official title: Phase 3, Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Combined With Osimertinib vs Platinum-Based Chemotherapy in Subjects With c-Met Overexpressing (OE) EGFR Mutant, Locally Advanced/Metastatic Non-Squamous NSCLC After a First Progression on Prior Third Generation EGFR TKi Treatment

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to assess how telisotuzumab vedotin in combination with osimertinib affects the disease state compared to standard of care in adult participants with locally advanced/metastatic non-squamous NSCLC that has a mutation in the epidermal growth factor receptor (EGFR) gene and that overexpresses the c-Met protein. Change in disease activity will be assessed.

Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC that overexpresses the c-Met protein. Participants are randomly placed in one of the two groups to receive telisotuzumab vedotin and osimertinib or standard of care chemotherapy. Approximately 250 adult participants with locally advanced/metastatic non-squamous NSCLC that has a mutation in the EGFR gene and that overexpresses the c-Met protein will be enrolled in the study in approximately 180 sites worldwide.

Read more

Participants will receive intravenous telisotuzumab vedotin every 2 weeks in combination with oral osimertinib tablets daily or standard of care chemotherapy (carboplatin/pemetrexed or cisplatin/pemetrexed as prescribed by the physician). Overall duration of the study is estimated to be approximately 47 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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Being tested
Telisotuzumab Vedotin, Osimertinib, Cisplatin, Carboplatin, Pemetrexed
Keywords
Non-Small Cell Lung Cancer, Telisotuzumab Vedotin, ABBV-399, Osimertinib, Cisplatin, Carboplatin, Pemetrexed, c-Met, NSCLC, Teliso-V, TeliMET NSCLC-03
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.

Study groups in NCT06093503
Study groupRoleWhat they receive
Telisotuzumab Vedotin and OsimertinibExperimentalParticipants will receive telisotuzumab vedotin every 2 weeks in combination with osimertinib, until disease progression or unacceptable toxicity.
Receives: Drug: Telisotuzumab Vedotin; Drug: Osimertinib
Standard of CareExperimentalParticipants will receive standard of care chemotherapy (carboplatin/pemetrexed or cisplatin/pemetrexed as prescribed by the physician), until disease progression or unacceptable toxicity.
Receives: Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed

What is being measured

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

  1. PFS in the Population of Participants with no Central Nervous System (CNS) Metastases at Baseline

    PFS is defined as the time from randomization to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 per ICR or death from any cause, whichever occurs earlier. Participants with no PFS event will be censored at the last evaluable radiographic assessment per ICR. Participants with no event and no evaluable post-baseline assessment will be censored at randomization.

    Measured: Up to Approximately 41 Months

Secondary outcomes (14)

  1. PFS in the Overall Population

    PFS is defined as the time from randomization to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 per ICR or death from any cause, whichever occurs earlier.

    Measured: Up to Approximately 41 Months

  2. Overall Response (OR) in the Population of Participants with no CNS Metastases at Baseline

    OR (per ICR) is defined as participants achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) per ICR based on RECIST v1.1.

    Measured: Up to Approximately 41 Months

  3. OR in the Overall Population

    OR (per ICR) is defined as participants achieving a best overall response of confirmed CR or confirmed PR per ICR based on RECIST v1.1.

    Measured: Up to Approximately 41 Months

  4. Duration of Response (DoR) in the Population of Participants with no CNS Metastases at Baseline

    DoR is defined for confirmed responders as the time from the initial response (CR or PR) per ICR to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause, whichever occurs first.

    Measured: Up to Approximately 41 Months

  5. DoR in the Overall Population

    DoR is defined for confirmed responders as the time from the initial response (CR or PR) per ICR to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause, whichever occurs first.

    Measured: Up to Approximately 41 Months

  6. Overall Survival (OS) in the Population of Participants with no CNS Metastases at Baseline

    OS is defined as the time from randomization to the event of death from any cause.

    Measured: Up to Approximately 41 Months

  7. OS in the Overall Population

    OS is defined as the time from randomization to the event of death from any cause.

    Measured: Up to Approximately 41 Months

  8. Change in Physical Functioning using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) in the Population of Participants with no CNS Metastases at Baseline

    The EORTC QLQ-LC13 is the lung cancer specific module of the core EORTC QLQ-C30.2 The QLQ-LC13 includes 13 questions that include both multi-item and single-item scales of lung cancer-associated symptoms (e.g., pain, coughing, hemoptysis, and dyspnea) and side-effects from chemo- and radiotherapy (e.g., hair loss, neuropathy, sore mouth and dysphagia). With the exception of 2 pain questions, which have dichotomous response categories (no or yes) and a free response if 'yes' is selected, all items on the QLQ-LC13 are scored on a 4-point Likert scale ranging from 1 (not at all) to (very much). The items have a 1-week recall period. All scale and item scores are linearly transformed to a 0 to 100 scale, with higher scores representing increasing symptom levels or impacts.

    Measured: Up to 41 Months

  9. Change in Physical Functioning using EORTC QLQ-LC13 in the Overall Population

    The EORTC QLQ-LC13 is the lung cancer specific module of the core EORTC QLQ-C30.2 The QLQ-LC13 includes 13 questions that include both multi-item and single-item scales of lung cancer-associated symptoms (e.g., pain, coughing, hemoptysis, and dyspnea) and side-effects from chemo- and radiotherapy (e.g., hair loss, neuropathy, sore mouth and dysphagia). With the exception of 2 pain questions, which have dichotomous response categories (no or yes) and a free response if 'yes' is selected, all items on the QLQ-LC13 are scored on a 4-point Likert scale ranging from 1 (not at all) to (very much). The items have a 1-week recall period. All scale and item scores are linearly transformed to a 0 to 100 scale, with higher scores representing increasing symptom levels or impacts.

    Measured: Up to 41 Months

  10. Change in Physical Functioning as Measured by the Physical Functioning Domain of the EORTC QLQ-C30 in the Population of Participants with no CNS Metastases at Baseline

    The EORTC QLQ-C30 assesses health-related quality of life in cancer patients participating in clinical trials. The EORTC QLQ-C30 comprises 5 functional scales (physical, role, emotional, social, cognitive), 8 single-item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, and dyspnea), as well as subscales assessing global health/quality of life and financial impact. Raw scores are transformed to a scale of 0 to 100, with higher scores representing better functioning/quality of life and greater symptom burden.

    Measured: Up to 41 Months

  11. Change in Physical Functioning as Measured by the Physical Functioning Domain of the EORTC QLQ-C30 in the Overall Population

    The EORTC QLQ-C30 assesses health-related quality of life in cancer patients participating in clinical trials. The EORTC QLQ-C30 comprises 5 functional scales (physical, role, emotional, social, cognitive), 8 single-item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, and dyspnea), as well as subscales assessing global health/quality of life and financial impact. Raw scores are transformed to a scale of 0 to 100, with higher scores representing better functioning/quality of life and greater symptom burden.

    Measured: Up to 41 Months

  12. Change in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-C30 in the Population of Participants with no CNS Metastases at Baseline

    The EORTC QLQ-C30 assesses health-related quality of life in cancer patients participating in clinical trials. The EORTC QLQ-C30 comprises 5 functional scales (physical, role, emotional, social, cognitive), 8 single-item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, and dyspnea), as well as subscales assessing global health/quality of life and financial impact. Raw scores are transformed to a scale of 0 to 100, with higher scores representing better functioning/quality of life and greater symptom burden.

    Measured: Up to 41 Months

  13. Change in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-C30 in the Overall Population

    The EORTC QLQ-C30 assesses health-related quality of life in cancer patients participating in clinical trials. The EORTC QLQ-C30 comprises 5 functional scales (physical, role, emotional, social, cognitive), 8 single-item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, and dyspnea), as well as subscales assessing global health/quality of life and financial impact. Raw scores are transformed to a scale of 0 to 100, with higher scores representing better functioning/quality of life and greater symptom burden.

    Measured: Up to 41 Months

  14. Percentage of Participants With Adverse Events (AEs)

    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.

    Measured: Up to 41 Months

Timeline

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

  1. First posted23 Oct 2023
  2. Study start31 May 2024 (estimated)
  3. Primary completion11 Apr 2028 (estimated)
  4. Study completion11 Apr 2028 (estimated)

Why it stopped: Strategic considerations

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06093503
Sponsor's protocol ID
M22-142
Other IDs
2022-502283-20-00
Status last verified
Jun 2024
First submitted
17 Oct 2023
Last updated
26 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Telisotuzumab Vedotin, Osimertinib and Cisplatin in people with Non-Small Cell Lung Cancer, run by AbbVie.

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 11 inclusion and 15 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: withdrawn, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

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?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS in the Population of Participants with no Central Nervous System (CNS) Metastases at Baseline (time frame: Up to Approximately 41 Months). 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 NCT06093503.

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 26 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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