Actively Recruiting
Neoadjuvant Umbrella Trial Directed by Next Generation Sequencing for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations (Without EGFR Sensitizing Mutations)
Led by Sun Yat-sen University · Updated on 2026-04-21
120
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate targeted therapies guided by next generation sequencing (NGS) for patients with treatment-naive unresectable stage III non-small-cell lung cancer (NSCLC) whose tumors have rare mutations, excluding common EGFR sensitizing mutations. The study addresses challenges in treating this large and diverse patient group and explores surgery after targeted drug treatment for those with specific rare genetic changes. Participants receive one of several targeted drug treatments based on their tumor's rare mutation type, including drugs like Sunvozertinib, Crizotinib, Pralsetinib, Larotrectinib, Savolitinib, Pyrotinib, Dabrafenib plus Trametinib, Glecirasib, or Ensartinib. Each treatment is given orally for three cycles, with each cycle lasting 28 days. Following these induction therapies, patients may undergo surgery. Throughout the study, participants will be monitored for the ability to undergo surgery within 6 months, side effects up to 24 months, disease-free survival, overall survival, and perioperative complications for up to 12 months. Blood and tissue samples will be collected before and after treatment. The study lasts several years, with follow-up assessments extending up to two years after the last patient is enrolled to evaluate treatment outcomes and safety.
CONDITIONS
Brief Title
Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Treatment-naive unresectable stage III NSCLC according to AJCC 8th edition
- Squamous or non-squamous NSCLC histology
- Tumor with rare mutation including EGFR exon20ins, ROS1 fusion, RET fusion, NTRK fusion, MET 14 exon, HER2, BRAF V600E, KRAS G12C, or ALK fusion
- No EGFR exon 19 deletions or exon 21 L858R activating mutation
- Willing to provide blood and specimens before and after treatment
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate blood counts: ANC ≥2.0 x 10^9/L, platelet count ≥100 x 10^9/L, hemoglobin ≥9 g/dL
- Adequate liver function: total bilirubin ≤1.5 x ULN, AST and ALT ≤2.5 x ULN
- Adequate kidney function: serum creatinine ≤1.25 x ULN or creatinine clearance ≥60 ml/min
- Female participants not pregnant or breastfeeding
- Provide written informed consent and able to comply with study procedures
You will not qualify if you...
- Disease not classified as unresectable stage III by investigator
- Known EGFR sensitive mutations
- Prior systemic antitumor therapy for NSCLC
- Untreated eye inflammation or infection or conditions risking eye inflammation
- History of another malignancy within last 5 years except certain cured cancers
- Active interstitial lung disease
- Known HIV infection or AIDS
- Inability to comply with study procedures
- Unstable systemic diseases including infections, uncontrolled hypertension, heart conditions, liver, kidney, or metabolic diseases
- Serious systemic disorders that may affect study completion or results
- Pregnant or nursing women
- Patients with small cell lung cancer mixed diagnosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 months
Participants receive targeted oral therapies specific to their tumor mutation. Each treatment cycle lasts 28 days, and participants receive 3 cycles of therapy before surgery.
3 treatment cycles with visits as per medication schedule
Duration - Up to 1 month
Participants undergo surgery to remove the tumor following targeted therapy and receive immediate post-operative care.
1 surgery visit and several immediate post-operative visits
Duration - Up to 12 months
Participants are monitored for perioperative complications and recovery over the following 12 months after surgery.
Approximately 6 post-operative visits
Duration - Up to 2 years
Participants are followed for disease-free and overall survival outcomes for up to 2 years after treatment completion.
Periodic visits over 2 years
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
S
Si-Yu Wang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
9
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