Clinical trial for Lung Cancer Stage III
Official title Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.
ClinicalTrials.gov ID: NCT06563999
What this study is testing
What is Sunvozertinib?
Sunvozertinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for lung cancer stage iii.
Also referred to as DZD9008.
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 umbrella trial directed by next generation sequencing (NGS) includes patients with treatment-naive unresectable stage III non-small-cell lung cancer (NSCLC). The aim of the umbrella study is to evaluate the efficacy of induction NGS-directed targeted therapies followed by surgery for stage III NSCLC patients whose tumor harbors a rare mutation.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- people must have treatment-naive unresectable stage III NSCLC according to the AJCC 8th edition staging;
- Squamous or non-squamous NSCLC histology;
- people should have a rare mutation based on NGS, including mutations of EGFR exon20ins, ROS1 fusion, RET fusion, NTRK fusion, MET 14 exon, HER2, BRAF...
- people should be without EGFR exon 19 deletions or exon 21 L858R activating mutation;
- Male and female, aged 18-75 years;
You likely can't join if
- Not unresectable stage III disease according to the investigator;
- people with known EGFR sensitive mutations;
- Previous treatment with systemic antitumor therapy for NSCLC;
- Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this.
- History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a...
- Evidence of clinically active interstitial lung disease;
See the full eligibility criteria
- people must have treatment-naive unresectable stage III NSCLC according to the AJCC 8th edition staging;
- Squamous or non-squamous NSCLC histology;
- people should have a rare mutation based on NGS, including mutations of EGFR exon20ins, ROS1 fusion, RET fusion, NTRK fusion, MET 14 exon, HER2, BRAF V600E, KRAS G12C, and ALK fusion.
- people should be without EGFR exon 19 deletions or exon 21 L858R activating mutation;
- Male and female, aged 18-75 years;
- Blood and specimens before and after treatment must be provided;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level);
- Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN;
- Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min;
- Female people should not be pregnant or breast-feeding;
- Written informed consent provided. Being willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study.
- Not unresectable stage III disease according to the investigator;
- people with known EGFR sensitive mutations;
- Previous treatment with systemic antitumor therapy for NSCLC;
- Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this.
- History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell...
- Evidence of clinically active interstitial lung disease;
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);
- Inability to comply with protocol or study procedures;
- Any unstable systemic disease (including active infection, active tuberculosis uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac...
- A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study and may confuse the study results;
- Women who are pregnant or nursing.
- Ingredients mixed with small cell lung cancer patients.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, 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.