Neoadjuvant Toripalimab for Non-squamous NSCLC With EGFR Mutation
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age17-70
SponsorPeking University People's Hospital
About this trial
This study was designed to investigate the efficacy and safety of neoadjuvant Toripalimab (anti-PD1) plus chemotherapy for patients with resectable II-IIIB non-squamous NSCLC harboring EGFR mutation, and to explore the potential predictive and prognostic biomarkers, aiming to provide more abundant evidences for the preoperative treatment decision of non-squamous NSCLC patients.
Eligibility criteria
Qualifiers
Provision of signed informed consent by the patient or legally acceptable representative;
Previously untreated, histologically confirmed resectable stage II-IIIA, IIIB(N2) (AJCC staging 8th edition) non-squamous non-small cell lung cancer;
Adequate tissue samples for PD-L1 immunohistochemical testing and gene mutations test by RT-pCR or NGS, or consent for blood RT-PCR or NGS if tissue samples are insufficient;
Harboring EGFR mutation (19del or L858R);
Disqualifiers
Pathological histologically confirmed small cell lung cancer, squamous epithelial cell carcinoma and other pathological subtypes cannot be enrolled;
Patients with advanced or metastatic lung cancer, or unresectable lung cancer, or who have received previous systemic anti-tumour therapy such as immunotherapy, chemotherapy or targeted therapy cannot be enrolled;
Patients with a history of active autoimmune disease or autoimmune disease that is likely to recur cannot be enrolled;
Patients with active hepatitis B and C requiring relevant antiviral therapy need to have HBV-DNA <500 IU/ml and have been on anti-HBV treatment for at least 14 days prior to study entry and continue treatment during the treatment period; HCV RNA-positive patients should be excluded;
Trial design
Treatments tested in this trial
- Toripalimab plus Chemotherapy
Treatment groups
126 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Peking University People's Hospital
Lead sponsor
Shanghai Junshi Bioscience Co., Ltd.
Collaborator
Source ClinicalTrials.gov