RecruitingPhase 2NCT06563999

Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.

Neoadjuvant Umbrella Trial Directed by Next Generation Sequencing for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations (Without EGFR Sensitizing Mutations)


Sponsor

Sun Yat-sen University

Enrollment

120 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is an umbrella trial for patients with advanced (stage III, unresectable) non-small cell lung cancer (NSCLC) who have rare genetic mutations in their tumors. Each patient is matched to a targeted therapy based on their specific mutation. The goal is to determine whether matching treatment to the mutation improves outcomes. **You may be eligible if...** - You are age 18–75 with stage III NSCLC that cannot be surgically removed - Your tumor has been tested with a genetic panel (NGS) and carries a rare mutation such as EGFR exon 20 insertion, ROS1, RET, NTRK, MET, HER2, BRAF V600E, KRAS G12C, or ALK fusion - You have not had any prior systemic treatment for lung cancer - You are in good general health (ECOG 0–1) **You may NOT be eligible if...** - Your tumor has a common EGFR mutation (exon 19 deletion or L858R) - Your lung cancer has already been treated with systemic therapy - You are pregnant or breastfeeding - You have significant inflammation in your eyes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSunvozertinib

300 mg orally once a day, 28 days as one cycle.

DRUGCrizotinib

300 mg orally once a day, 28 days as one cycle.

DRUGPralsetinib

400 mg orally once a day, 28 days as one cycle.

DRUGLarotrectinib

100 mg orally twice daily, 28 days as one cycle.

DRUGSavolitinib

600 mg or 400 mg (weight \<50 kg) orally once a day, 28 days as one cycle.

DRUGPyrotinib

400 mg orally once a day, 28 days as one cycle.

DRUGDabrafenib+Trametinib

Dabrafenib 150 mg orally twice daily, 28 days as one cycle. Trametinib 150 mg orally twice daily, 28 days as one cycle.

DRUGGlecirasib

800 mg daily orally, 28 days as one cycle.

DRUGEnsartinib

225 mg daily orally, 28 days as one cycle.


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06563999


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