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.
Previous studies have confirmed the efficacy of neoadjuvant immunotherapy in NSCLC patients without driver gene mutation, while its efficacy in driver gene mutated patients is still controversial. 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
Therapy 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.
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 surgery
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 surgery
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 surgery
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 surgery
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 surgery
Major Pathologic Response (MPR) Rate in non-squamous NSCLC with different PD-L1 expression levels
Assessing MRP rates in the PD-L1 TPS≥1% and PD-L1 TPS\<1% groups separately.
Time frame: Within 1 week after surgery
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Event-free Survival (EFS)
EFS is defined as the time from participation to any of the following events: progression of disease, recurrence disease, or death due to any cause. Progression/recurrence will be assessed either by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Time frame: Up to 24 months after participation
The Safety and Tolerability
To assess the safety and tolerability of neoadjuvant immuno-chemotherapy in patients with resectable stage II-IIIB non-squamous non-small cell lung cancer harboring EGFR mutations, including as follows: number, frequency and proportion of patients with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI) and on-study deaths.
Time frame: Up to 24 months after participation