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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age: 18 Years and older

• ECOG physical score 0-1 points; expected survival time ≥ 3 months;

• Pathologically confirmed diagnosis with Stage IIB-IIIB NSCLC which harbored rare driver alteration including RET fusions, BRAF (V600E or non-V600E but confirmed driver mutations), ERBB2 exon20 insertion, MET amplification (FISH confirmed) or exon 14 skipping. Suspected N2 disease should be confirmed by either mediastinoscopy or EBUS. N1 disease could be determined through PET/CT but biopsy of primary lung cancer is needed;

• Lung function capacity capable of tolerating the proposed lung surgery

• Available tissue of tumor for PD-L1 test

• Subjects voluntarily joined the study and signed informed consent, with good compliance to follow-up.

Locations
Other Locations
China
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
RECRUITING
Guanzhou
Contact Information
Primary
Wen-Zhao Zhong, Ph.D
syzhongwenzhao@scut.edu.cn
+86 02083827812
Backup
Rui Fu, Ph.D
ruifu66@foxmail.com
+86 02083827812
Time Frame
Start Date: 2023-04-04
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 30
Treatments
Experimental: Toripalimab plus chemotherapy
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.
Sponsors
Leads: Guangdong Provincial People's Hospital
Collaborators: Shanghai Junshi Bioscience Co., Ltd.

This content was sourced from clinicaltrials.gov

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