Non-Small Cell Lung Cancer study: Ivonescimab Injection vs Pembrolizumab Injection
Official title Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1
ClinicalTrials.gov ID: NCT06767514
What this study is testing
What is Ivonescimab Injection?
An investigational IV injection being studied as a first‑line treatment for metastatic non‑small cell lung cancer with high PD‑L1.
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
- This study is testing whether ivonescimab can help people with metastatic non‑small cell lung cancer live longer and keep the cancer from growing.
- Who it's for
- You may be able to join if you have metastatic non‑small cell lung cancer and your tumor shows high PD‑L1 levels.
- What's involved
- You would receive ivonescimab and have regular check‑ups to see how you are doing. The study will track your health and any side effects.
- Time commitment
- The study lasts about 2 years, with visits every few weeks at the start and then every few months afterward.
- Phase 3: a large, late-stage study
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
- Age ≥ 18 years old at the time of enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1
- Expected life expectancy ≥ 3 months
- Metastatic (Stage IV) NSCLC
- Histologically or cytologically confirmed squamous or non-squamous NSCLC
You likely can't join if
- Histologic or cytopathologic evidence of the presence of small cell lung carcinoma for which first-line approved therapies are indicated.
- Has received any prior therapy for NSCLC in the metastatic setting.
- Concurrent enrollment in another clinical study, unless patient is enrolled in a non-treatment clinical study or is completing survival follow -up.
- Known actionable genomic alterations for which first-line approved therapies are indicated
- Symptomatic CNS metastases, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the...
- Other prior malignancy (including previously treated NSCLC) unless the patient has undergone curative therapy with no evidence of recurrence of the...
See the full eligibility criteria
- Age ≥ 18 years old at the time of enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1
- Expected life expectancy ≥ 3 months
- Metastatic (Stage IV) NSCLC
- Histologically or cytologically confirmed squamous or non-squamous NSCLC
- Tumor demonstrates high PD-L1 expression ( TPS\>50%) based on a 22C3 immunohistochemistry ( IHC) clinical assay approved / cleared by local health authorities.
- At least one measurable noncerebral lesion according to RECIST 1.1
- No prior systemic treatment for metastatic NSCLC.
- Histologic or cytopathologic evidence of the presence of small cell lung carcinoma for which first-line approved therapies are indicated.
- Has received any prior therapy for NSCLC in the metastatic setting.
- Concurrent enrollment in another clinical study, unless patient is enrolled in a non-treatment clinical study or is completing survival follow -up.
- Known actionable genomic alterations for which first-line approved therapies are indicated
- Symptomatic CNS metastases, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease
- Other prior malignancy (including previously treated NSCLC) unless the patient has undergone curative therapy with no evidence of recurrence of the disease for 3 years prior to randomization
- Active autoimmune or lung disease requiring systemic therapy
- Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5
- Severe infection within 4 weeks prior to randomization
- Major surgical procedures or serious trauma within 4 weeks prior to randomization
- History of noninfectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease
The study team makes the final eligibility decision.
Where it is enrolling
- Chandler, Arizona, United States
- Phoenix, Arizona, United States
- Hot Springs, Arkansas, United States
- Jonesboro, Arkansas, United States
- Alameda, California, United States
- Anaheim, California, United States
- Beverly Hills, California, United States
- Cerritos, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Oxnard, California, United States
- San Diego, California, United States
- Sunnyvale, California, United States
- Torrance, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- Grand Junction, Colorado, United States
- Lone Tree, Colorado, United States
- Loveland, Colorado, United States
- Fort Lauderdale, Florida, United States
+ 232 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; Phoenix, Arizona, United States; Hot Springs, Arkansas, United States; Jonesboro, Arkansas, United States; Alameda, California, United States; Anaheim, California, United States and 246 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.