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 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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Pills, Blood draws, Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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 effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the side effects and cancer changes from telisotuzumab adizutecan, given through a vein, plus osimertinib pills. It compares this treatment with osimertinib plus chemotherapy. It is for adults with non-squamous non-small cell lung cancer that has certain EGFR gene changes and has spread or cannot be removed by surgery.
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. 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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be fully active or able to walk and do light work, even if hard physical activity is limited.
- Agree to provide a new or stored tumor sample for c-Met testing, which checks for a protein. Results must be ready before you are assigned to a treatment group.
- Have at least one tumor that can be measured and has not had radiation. If there is only one, it must not have been biopsied within 14 days before the starting scans.
- Side effects from earlier cancer medicines must be mild or back to their starting level. Hair loss and some nerve damage are allowed.
- Have no major, life-threatening health condition and be expected by the study doctor to live at least 3 months.
- Have no prior EGFR-blocking medicine for locally advanced or spreading cancer, except as allowed by the study. After treatment given to prevent cancer from returning, the listing requires at least 126 months since the last dose.
- Have non-squamous non-small cell lung cancer confirmed by tissue or cell testing that is locally advanced or has spread. An approved or validated test must show an EGFR Exon 19 deletion or Exon 21 L858R gene change, with the report in your records.
Who can't join
- Have a history of interstitial lung disease, which can inflame or scar the lungs; lung inflammation that needed steroids taken by mouth or vein; or current lung inflammation on the screening chest scan.
- Have a history of certain lung scarring or inflammation, including idiopathic pulmonary fibrosis, organizing pneumonia, drug-caused pneumonitis, or pneumonitis with no known cause.
- Have cancer in the tissue around the brain and spinal cord, or pressure on the spinal cord that has not been fully treated with surgery or radiation.
- Have a history of another cancer, unless an allowed exception applies: cancer treated to cure it, with no active disease for 2 years and a low chance of returning; successfully treated nonmelanoma skin cancer; cancer limited to the surface of the cervix; or fully cured breast lobular or ductal carcinoma in situ, which has not spread into nearby tissue.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (18)
AZ
- Ironwood Cancer and Research Centers - Chandler /ID# 275443 · Chandler, AZ 85224More trials in Chandler
CA
- City of Hope National Medical Center /ID# 282241 · Duarte, CA 91010More trials in Duarte
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 284734 · Irvine, CA 92618More trials in Irvine
- USC Norris Comprehensive Cancer Center /ID# 275343 · Los Angeles, CA 90033More trials in Los Angeles
- Usc Norris Oncology/Hematology Treatment Center /ID# 278673 · Newport Beach, CA 92663More trials in Newport Beach
- UCLA - Santa Monica /ID# 276816 · Santa Monica, CA 90404More trials in Santa Monica
- City Of Hope - Upland /ID# 284650 · Upland, CA 91786More trials in Upland
CO
- University Colorado Cancer Center /ID# 275382 · Aurora, CO 80045-2517More trials in Aurora
FL
- Mid Florida Hematology And Oncology Center /ID# 275278 · Orange City, FL 32763More trials in Orange City
HI
- Kaiser Permanente Moanalua Medical Center /ID# 275942 · Honolulu, HI 96819More trials in Honolulu
IA
- The Iowa Clinic /ID# 276020 · West Des Moines, IA 50266More trials in West Des Moines
NE
- Nho - Revive Research Institute /ID# 276115 · Lincoln, NE 68506More trials in Lincoln
NV
- Renown Regional Medical Center /ID# 276049 · Reno, NV 89502More trials in Reno
TX
- Texas Oncology - South Austin /ID# 276033 · Austin, TX 78745More trials in Austin
- The University of Texas MD Anderson Cancer Center /ID# 275107 · Houston, TX 77030More trials in Houston
- Texas Oncology - Palestine Cancer Center /ID# 276034 · Palestine, TX 75801More trials in Palestine
VA
- Virginia Cancer Specialists - Fairfax /ID# 275071 · Fairfax, VA 22031More trials in Fairfax
WA
- University of Washington Medical Center /ID# 275866 · Seattle, WA 98195More trials in Seattle