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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Toripalimab plus Chemotherapy
DrugTherapy was administered on a 21-day regimen for 3 cycles, with Toripalimab (240mg, d1), carboplatin (AUC=5, d1) + pemetrexed (500 mg/m2, d1) for patients with lung adenocarcinoma and carboplatin (AUC=5, d1) + albumin-bound paclitaxel (260 mg/m2, d1) for patients with other subtypes.
Treatment groups
126 Participants
are divided into 2 treatment groupsGroup A: 19DEL cohortExperimental treatment 1 intervention
Group B: L858R cohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pathologic Complete Response (pCR) Rate
Pathologic complete response (pCR) rate is defined as the percentage of participants with no residual viable tumor in lung primary or lymph nodes as evaluated by blinded independent pathological review (BIPR).
Time frame
Within 1 week after surgerySecondary outcomes
1
Major Pathologic Response (MPR) Rate
Major pathologic response (MPR) rate is defined as the percentage of participants with less than or equal to 10% of residual viable tumor in lung primary or lymph nodes as evaluated by blinded independent pathological review (BIPR). Viable tumors in situ carcinoma should not be included in MPR calculation.
Time frame
Within 1 week after surgery2
Pathologic Complete Response (pCR) Rate in non-squamous NSCLC with different EGFR mutations status
Assessing pCR rates in the 19del and L858R groups separately.
Time frame
Within 1 week after surgery3
Major Pathologic Response (MPR) Rate in non-squamous NSCLC with different EGFR mutations status
Assessing MRP rates in the 19del and L858R groups separately.
Time frame
Within 1 week after surgery4
Pathologic Complete Response (pCR) Rate in non-squamous NSCLC with different PD-L1 expression levels
Assessing pCR rates in the PD-L1 TPS≥1% and PD-L1 TPS\<1% groups separately.
Time frame
Within 1 week after surgeryLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking University People's Hospital
Lead sponsor
Shanghai Junshi Bioscience Co., Ltd.
Collaborator
Source ClinicalTrials.gov
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