Actively Recruiting
Neoadjuvant Immunotherapy in Rare Mutations Localized NSCLC
Led by Guangdong Provincial People's Hospital · Updated on 2023-04-05
30
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
Sponsors
G
Guangdong Provincial People's Hospital
Lead Sponsor
S
Shanghai Junshi Bioscience Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant Immunotherapy in Rare Mutations Localized NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older
- ECOG physical score 0-1 and expected survival of at least 3 months
- Pathologically confirmed stage IIB-IIIB NSCLC with rare mutations including RET fusions, BRAF (V600E or confirmed driver mutations), ERBB2 exon20 insertion, MET amplification (FISH confirmed), or exon 14 skipping
- Suspected N2 disease confirmed by mediastinoscopy or EBUS; N1 disease confirmed by PET/CT and biopsy
- Lung function adequate to tolerate proposed lung surgery
- Available tumor tissue for PD-L1 testing
- Voluntary participation with signed informed consent and ability to comply with follow-up
You will not qualify if you...
- Stage I or IV NSCLC
- Prior use of anti-tumor drugs or radiotherapy
- Presence of sensitive EGFR alteration, ALK fusion, ROS1 fusion, or other driver mutations combined with MDM2/MDM4 amplification
- Histologically confirmed small cell lung cancer or mixed small cell and non-small cell lung cancer
- History of active bleeding within 6 months, current thrombolysis or anticoagulant therapy, or risk of gastrointestinal bleeding or active hemoptysis
- Severe cardiovascular or pulmonary disease, serious infections, or gastrointestinal abnormalities affecting drug intake or absorption
- Active autoimmune disease with activity, except certain controlled conditions
- Active hepatitis B or C infection
- HIV or AIDS
- Other active cancers within 5 years
- Pregnant or breastfeeding women, or those unwilling/unable to use effective contraception
- Low compliance or unwillingness to take medications and follow study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
Guanzhou, Guangdong, China, 510080
Actively Recruiting
Research Team
W
Wen-Zhao Zhong, Ph.D
CONTACT
R
Rui Fu, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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