Neoadjuvant Immunotherapy in Rare Mutations Localized NSCLC
NCT05800340 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2023-04-05
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.
Conditions
- Non-Small Cell Lung Cancer
- RET Driver Mutation
- BRAF V600 Mutation
- Erb-B2 Receptor Tyrosine Kinase Exon 20 Mutation
- MET Amplification
- MET Exon 14 Skipping Mutation
Interventions
- BIOLOGICAL
-
Toripalimab
240mg Q3W
- DRUG
-
Nab paclitaxel
135 mg/m2, d1, 8 Q3W
- DRUG
-
Pemetrexed
500mg/m2, d1 Q3W
- DRUG
-
AUC 5, d1 Q3W
Sponsors & Collaborators
-
Shanghai Junshi Bioscience Co., Ltd.
collaborator OTHER -
Guangdong Provincial People's Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-04
- Primary Completion
- 2024-12-31
- Completion
- 2026-12-31
Countries
- China
Study Locations
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