Clinical trial for Non-Squamous Non-Small Cell Lung Cancer
Official title 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
ClinicalTrials.gov ID: NCT07005102
What this study is testing
What is Telisotuzumab Adizutecan?
This is an investigational medicine being studied to treat non-squamous non-small cell lung cancer. It is designed to target specific proteins on cancer cells to help stop their growth.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see how safe the drug is and whether it changes the cancer’s activity when used with osimertinib or standard chemotherapy.
- Who it's for
- Adults with locally advanced or metastatic EGFR‑mutated non‑squamous non‑small cell lung cancer.
- What's involved
- Participants will receive the drug by IV infusion and take osimertinib tablets. They will have regular clinic visits, blood tests, questionnaires, and medical checks to monitor safety and cancer activity.
- Time commitment
- The study lasts about 76 months, with many scheduled visits at a hospital or clinic throughout the treatment period.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 during the screening period and prior to dosing of study treatment on...
- Must consent to provide recently obtained formalin-fixed, paraffin-embedded (FFPE) tumor tissue (ideally collected during or after locally advanced...
- Must have at least one non-irradiated measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Any toxicities from prior systemic anti-cancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Grade 1 or...
- Should not have any major, life-threatening conditions and life expectancy as determined by the investigator should be at least 3 months.
You likely can't join if
- History of interstitial lung disease (ILD), pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on...
- 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...
- Successfully treated nonmelanoma skin cancer.
See the full eligibility 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...
- Must have at least one non-irradiated measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- 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...
- 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).
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Chandler, Arizona, United States
- Duarte, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Santa Monica, California, United States
- Upland, California, United States
- Aurora, Colorado, United States
- Orange City, Florida, United States
- Honolulu, Hawaii, United States
- Lincoln, Nebraska, United States
- Reno, Nevada, United States
- Austin, Texas, United States
- Houston, Texas, United States
- Palestine, Texas, United States
- Fairfax, Virginia, United States
- Seattle, Washington, United States
- Liverpool, New South Wales, Australia
- Woodville South, South Australia, Australia
- Heidelberg, Victoria, Australia
+ 38 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chandler, Arizona, United States; Duarte, California, United States; Irvine, California, United States; Los Angeles, California, United States; Newport Beach, California, United States; Santa Monica, California, United States and 52 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.