RecruitingPhase 2NCT05800340

Neoadjuvant Immunotherapy in Rare Mutations Localized NSCLC

Neoadjuvant Toripalimab Combined With Chemotherapy in Rare Mutations Stage IIB-IIIB NSCLC


Sponsor

Guangdong Provincial People's Hospital

Enrollment

30 participants

Start Date

Apr 4, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Phase II, single-arm, open-label single center study that assess clinical feasibility and safety of 3 cycles neoadjuvant Toripalimab plus chemotherapy in rare mutations stage IIB-IIIB NSCLC followed by optional adjuvant treatment upon investigators' decisions.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether giving immunotherapy before surgery (called neoadjuvant therapy) helps people with early-stage lung cancer that carries rare genetic mutations. The goal is to shrink the tumor before removal and potentially improve long-term outcomes. **You may be eligible if:** - You are 18 or older - You have been diagnosed with Stage IIB–IIIB non-small cell lung cancer (NSCLC) - Your tumor carries a rare genetic change such as a RET fusion, BRAF mutation, HER2 exon 20 insertion, or MET amplification - Your tumor has not been previously treated with any cancer drugs or radiation - You are healthy enough to undergo lung surgery **You may NOT be eligible if:** - You have Stage I or Stage IV lung cancer - Your tumor has common EGFR or ALK mutations (these have different standard treatments) - You have small cell lung cancer - You have had active bleeding in the past 6 months - You are pregnant 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

BIOLOGICALToripalimab

240mg Q3W

DRUGNab paclitaxel

135 mg/m2, d1, 8 Q3W

DRUGPemetrexed

500mg/m2, d1 Q3W

DRUGCarboplatin

AUC 5, d1 Q3W


Locations(1)

Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences

Guanzhou, Guangdong, China

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NCT05800340


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