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3 cycles of neoadjuvant Toripalimab (240mg every 3 weeks) with nab-paclitaxel + carboplatin, or pemetrexed + carboplatin (decided by investigators; nab-paclitaxel 135 mg/m2, d1, 8 and carboplatin AUC 5, d1 every 3 weeks; pemetrexed, 500mg/m2 d1 every 3 weeks) will be administered before surgery, followed by optional adjuvant treatment including chemotherapy for 3-4 cycles or rare mutations-TKIs for up to 2 years or till disease progression or unacceptable toxicity.

Toripalimab

Nab paclitaxel

Wen-Zhao Zhong, Ph.D

Rui Fu, Ph.D

Chao Zhang, Ph.D

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.

30 eligible patients will be enrolled and 3 cycles of Toripalimab 240mg + chemotherapy (Nab-paclitaxel + carboplatin, or pemetrexed + carboplatin) will be administered. Rare mutations include RET fusions, BRAF (V600E or non-V600E but confirmed driver mutations), ERBB2 exon20 insertion, MET amplification (FISH confirmed) or exon 14 skipping. Dynamic blood samples before, during or after neoadjuvant treatment will be obtained for exploratory analysis. Patients who showed inferior response to neoadjuvant treatment leading to unresectable disease will be scheduled for local radiation or other potential subsequent treatment regarding multidisciplinary discussion. After completion of local treatment (surgery or radiation), patients will be provided with optional adjuvant treatment including chemotherapy or/and rare mutations TKI upon investigators' consideration. The primary objective of the study is pathological complete response (pCR) defined as no residue tumor found in both primary lung cancer and metastatic lymph nodes.

3 cycles of neoadjuvant Toripalimab (240mg every 3 weeks) with nab-paclitaxel + carboplatin, or pemetrexed + carboplatin (decided by investigators; nab-paclitaxel 135 mg/m2, d1, 8 and carboplatin AUC 5, d1 every 3 weeks; pemetrexed, 500mg/m2 d1 every 3 weeks) will be administered before surgery, followed by optional adjuvant treatment including chemotherapy for 3-4 cycles or rare mutations-TKIs for up to 2 year or till disease progression or unacceptable toxicity.

Neoadjuvant Immunotherapy in Rare Mutations Localized NSCLC

Neoadjuvant Toripalimab Combined With Chemotherapy in Rare Mutations Stage IIB-IIIB NSCLC

Evaluation of the pathological complete response: The pathological complete response is defined as the absence of residual tumor in both lung and lymph nodes after neoadjuvant treatment.

Percentage of Participants with Major Pathologic Response. MPR was defined as percentage of tumor cells within tumor bed less than 10% for both primary lung lesions and metastatic lymph nodes.

Event-free survival (EFS) is defined as the length of time from initiation of neoadjuvant treatment to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause.

Overall survival (OS) is defined as the time between the date of initiation of neoadjuvant treatment and the date of death.

Incidence of all grade AE which has been confirmed to be correlated with neoadjuvant treatment or surgery.

Shanghai Junshi Bioscience Co., Ltd.

Guangdong Provincial People's Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neoadjuvant Immunotherapy in Rare Mutations Localized NSCLC	NCT05800340	Non-Small Cell ... RET Driver Muta... BRAF V600 Mutat... Erb-B2 Receptor... MET Amplificati... MET Exon 14 Ski...	Toripalimab Nab paclitaxel Pemetrexed Carboplatin	18 Years -	Guangdong Provincial People's Hospital
Neoadjuvant Immunotherapy in Rare Mutations Localized NSCLC	NCT05800340	Non-Small Cell ... RET Driver Muta... BRAF V600 Mutat... Erb-B2 Receptor... MET Amplificati... MET Exon 14 Ski...	Toripalimab Nab paclitaxel Pemetrexed Carboplatin	18 Years -	Guangdong Provincial People's Hospital
Neoadjuvant Immunotherapy in Rare Mutations Localized NSCLC	NCT05800340	Non-Small Cell ... RET Driver Muta... BRAF V600 Mutat... Erb-B2 Receptor... MET Amplificati... MET Exon 14 Ski...	Toripalimab Nab paclitaxel Pemetrexed Carboplatin	18 Years -	Guangdong Provincial People's Hospital

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