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Taking people in ChinaPhase 2

Targeted drugs chosen by tumor gene testing, then surgery, for lung cancer

Tests targeted drugs, then surgery, in lung cancer with rare mutations.

Key facts

Who runs it
Sun Yat-sen University
Where
Guangzhou, ChinaSee the site
Trial code
Registry title
Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.
Status
Recruiting
Phase
Phase 2
People taking part
120 people, planned
Started
1 Nov 2024
Expected to end
1 Nov 2029
Type of study
Interventional, 9 groups
Treatments tested
  • Sunvozertinib
  • Crizotinib
  • Pralsetinib
  • Larotrectinib
  • Savolitinib
  • Pyrotinib
  • Dabrafenib+Trametinib
  • Glecirasib
  • Ensartinib
Record updated
21 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with stage III lung cancer that cannot be removed by surgery, has not been treated yet, and carries a rare gene change.

Age
18 to 75 years
Sex
All sexes can join.
Disease stage
Unresectable stage III non-small-cell lung cancer (NSCLC), squamous or non-squamous type, not treated before.
Earlier treatment
No earlier whole-body (systemic) anticancer treatment for NSCLC.
Biomarker or test result
A rare mutation found by NGS: EGFR exon20ins, ROS1 fusion, RET fusion, NTRK fusion, MET 14 exon, HER2, BRAF V600E, KRAS G12C or ALK fusion. No EGFR exon 19 deletion or exon 21 L858R mutation.

Main reasons for not taking part

  • Known EGFR sensitive mutations
  • Earlier systemic anticancer treatment for NSCLC
  • Another cancer in the last 5 years, with a few exceptions
  • Clinically active interstitial lung disease
  • Known HIV infection or AIDS

The registry criteria, word for word

Show all 24 criteriaShow less

Who can take part

  • Subjects must have treatment-naive unresectable stage III NSCLC according to the AJCC 8th edition staging
  • Squamous or non-squamous NSCLC histology
  • Subjects 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
  • Subjects 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 subjects 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

Who cannot take part

  • Previous treatment with systemic antitumor therapy for NSCLC
  • Any unstable systemic disease (including active infection, active tuberculosis uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease)
  • 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
  • Not unresectable stage III disease according to the investigator
  • 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 carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted
  • Evidence of clinically active interstitial lung disease
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • Ingredients mixed with small cell lung cancer patients
  • Subjects with known EGFR sensitive mutations
  • Inability to comply with protocol or study procedures
  • Women who are pregnant or nursing

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in China

  • Sun Yat-sen University Cancer CenterGuangzhou, ChinaContact: Si-Yu Wang, DoctorTaking people

About the trial

What the trial wants to find out

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.

The 9 groups in the trial

  • Treatment 1-SunvozertinibTreatment being tested

    Patients with EGFR exon20ins mutation receive Sunvozertinib 300 mg orally once a day, 28 days as one cycle for 3 cycle.

    Treatment: Sunvozertinib

  • Treatment 2-CrizotinibTreatment being tested

    Patients with ROS1 fusion mutation receive Crizotinib 250mg orally once a day, 28 days as one cycle for 3 cycle.

    Treatment: Crizotinib

  • Treatment 3-PralsetinibTreatment being tested

    Patients with RET fusion mutation receive Pralsetinib 400mg orally once a day, 28 days as one cycle for 3 cycle.

    Treatment: Pralsetinib

  • Treatment 4-LarotrectinibTreatment being tested

    Patients with NTRK fusion mutation receive Larotrectinib 100 mg orally twice daily, 28 days as one cycle for 3 cycle.

    Treatment: Larotrectinib

  • Treatment 5-SavolitinibTreatment being tested

    Patients with MET 14 exon mutation receive Savolitinib 600 mg or 400 mg (weight \<50 kg) orally once a day, 28 days as one cycle for 3 cycle.

    Treatment: Savolitinib

  • Treatment 6-PyrotinibTreatment being tested

    Patients with HER2 mutation receive Pyrotinib 400 mg orally once a day, 28 days as one cycle for 3 cycle.

    Treatment: Pyrotinib

  • Treatment 7-Dabrafenib+TrametinibTreatment being tested

    Patients with BRAF V600E mutation receive Dabrafenib plus Trametinib, 28 days as one cycle for 3 cycle.

    Treatment: Dabrafenib+Trametinib

  • Treatment 8-GlecirasibTreatment being tested

    Patients with KRAS G12C mutation receive Glecirasib 800 mg daily orally, 28 days as one cycle for 3 cycle.

    Treatment: Glecirasib

  • Treatment 9-EnsartinibTreatment being tested

    Patients with ALK fusion mutation receive Ensartinib 225 mg daily orally, 28 days as one cycle for 3 cycle.

    Treatment: Ensartinib

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Neoadjuvant Umbrella Trial Directed by Next Generation Sequencing for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations (Without EGFR Sensitizing Mutations)
Plain-language title
Targeted drugs chosen by tumor gene testing, then surgery, for lung cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06563999, who can take part
Record updated
21 April 2026