BridgeMD
New treatment option for Non-small Cell Lung Cancer
Official title A Phase III Study to Assess the Effects of Almonertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT04951635
What this study is testing
What is Almonertinib?
Almonertinib is an investigational medicine, given as an once-daily, being studied as a potential treatment for non-small cell lung cancer.
Also referred to as HS-10296.
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
- To assess the efficacy and safety of Almonertinib versus placebo following chemoradiation in patients with stage III unresectable epidermal growth factor receptor mutation-positive (EGFRm+) non-small cell lung cancer (NSCLC).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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
- Provision of informed consent before any study-specific procedures, sampling and analyses.
- Male or female, age at least 18 years.
- Histologically or cytologically confirmed diagnosis of primary non-small lung cancer (NSCLC) on predominantly non-squamous pathology who present with...
- The tumor harbours one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19Del, L858R), either alone or in...
- Patients must have received either concurrent chemoradiation or sequential chemoradiation including at least 2 cycles of platinum based chemotherapy...
You likely can't join if
- Treatment with any of the following:
- Prior treatment with any prior chemotherapy, radiation therapy, immunotherapy or investigational agents for NSCLC outside of that received in the...
- Prior treatment with EGFR-TKI therapy.
- Major surgery (including primary tumor surgery, excluding placement of vascular access) within 4 weeks of the first dose of study drug.
- Patients currently receiving (unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be...
- Treatment with an investigational drug within five half-lives of the compound or any of its related material.
See the full eligibility criteria
- Provision of informed consent before any study-specific procedures, sampling and analyses.
- Male or female, age at least 18 years.
- Histologically or cytologically confirmed diagnosis of primary non-small lung cancer (NSCLC) on predominantly non-squamous pathology who present with locally advanced, unresectable (Stage III) disease (according to AJCC...
- The tumor harbours one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19Del, L858R), either alone or in combination with other EGFR mutations including T790M, assessed by cobas®...
- Patients must have received either concurrent chemoradiation or sequential chemoradiation including at least 2 cycles of platinum based chemotherapy and a total dose of radiation of 60 Gy ±10% (54 to 66 Gy).
- Chemoradiation must be completed ≤6 weeks prior to randomization.
- Patients must not have had disease progression during or following definitive platinum-based, chemoradiation therapy.
- A WHO performance status of 0-1 with no deterioration over the past 2 weeks and a minimum life expectancy of 12 weeks.
- Female patients should be using adequate contraceptive measures and should not be breastfeeding at the screening period, during the study, and six months after the last dosing of study. A pregnancy test should be done...
- Male patients should be willing to use barrier contraception (condoms)
- Treatment with any of the following:
- Prior treatment with any prior chemotherapy, radiation therapy, immunotherapy or investigational agents for NSCLC outside of that received in the definitive setting for Stage III disease (chemotherapy and radiotherapy...
- Prior treatment with EGFR-TKI therapy.
- Major surgery (including primary tumor surgery, excluding placement of vascular access) within 4 weeks of the first dose of study drug.
- Patients currently receiving (unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers and inhibitors of cytochrome CYP3A4 (at least 7 days...
- Treatment with an investigational drug within five half-lives of the compound or any of its related material.
- Mixed small cell and non-small cell lung cancer histology.
- History of interstitial lung disease (ILD) prior to chemoradiation.
- Symptomatic pneumonitis following chemoradiation.
- Inadequate bone marrow reserve or organ function.
- Any unresolved toxicity Common Terminology Criteria for Adverse Events (CTCAE) ≥ Grade 2 from the prior chemoradiation therapy.
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc) \> 470 ms obtained from 3 electrocardiograms (ECGs), using the screening clinic's ECG machine and Fridericia's formula for QT interval correction (QTcF).
- Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG (e.g., PR interval \> 250 ms).
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure or any concomitant medication known to prolong the QT interval.
- Left ventricular ejection fraction (LVEF) ≤ 40%.
- History of other malignancies, excluding fully treated non-melanoma skin cancer, in-situ cancer, or other solid tumors that hadn't recurrent for \> 5 years following the end of treatment.
- Any evidence of severe or uncontrolled systemic diseases (including uncontrolled hypertension and active bleeding diatheses) or active infection (including hepatitis B, hepatitis C, and human immunodeficiency virus...
- Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow the study drug that would preclude adequate absorption of Almonertinib.
- History of hypersensitivity to any active or inactive ingredient of Almonertinib or to drugs with a similar chemical structure or class to Almonertinib.
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
- Any severe and uncontrolled ocular disease that may, in the ophthalmologist's opinion, present a specific risk to the patient's safety.
- Any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient or interfere with study assessments.
The study team makes the final eligibility decision.
Where it's taking place
- Ji'nan, Shandong, China
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 - 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?
Study sites include Ji'nan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.