Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Antibodies

Pemetrexed

Immunomodulating Agents

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Participants will receive neoadjuvant Carrelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection and adjuvant Carrelizumab for 16 cycles.

Camrelizumab: 200mg, IV, day 1 of each 21-day cycle, neoadjuvant therapy : 3 cycles; Adjuvant therapy: 16cycles.

Carrelizumab

Nab-paclitaxel: 260mg/m\^2, IV, day 1 of each 21-day cycle, 3 cycles; Pemetrexed: 500 mg/m\^2, IV, day 1 of each 21-day cycle, 3 cycles.

Pemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel(Squamous NSCLC)

Carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 i.v. on day 1 of each 21-day cycle for 3 cycles.

Surgery must be done within the 4th-6th week from day 1 cycle 3 of neoadjuvant treatment (4-6 weeks after day 1 of cycle 3)

Surgery

Yongde Liao, PhD

Mingliang Wang, MD

The purpose of this study is to evaluate the safety and efficacy of Camrelizumab in combination with platinum doublet neoadjuvant chemotherapy before surgery \[neoadjuvant phase\], followed by Camrelizumab alone after surgery \[adjuvant phase\] in participants with unresectable stage III non-small cell lung cancer.

Concurrent chemoradiotherapy is the recommended therapeutic approach for patients with unresectable stage III non-small cell lung cancer(NSCLC), although surgery offers the chance of cure. With combined radiation and chemotherapy, the prognosis of unresectable stage III NSCLC remains poor. Immunotherapy combined with chemotherapy has been shown to be efficacious as treatment for advanced non-squamous non-small-cell lung cancer (NSCLC) without targetable genetic aberrations. Camrelizumab, a humanised monoclonal antibody against PD-1, has shown its efficacy in the treatment of advanced NSCLC. This study is to studying neoadjuvant camrelizumab plus double platinum based chemotherapy followed by surgery to see how well it works in treating patients with unresectable stage III NSCLC.

Neoadjuvant Immunotherapy and Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC

Induction Therapy With Chemoimmunotherapy Followed by Surgery for Unresectable Stage III Non-small Cell Lung Cancer: a Single-center, Single-arm, Prospective Clinical Study

MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.

Resectability rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.

The incidences and types of adverse events that occur during neoadjuvant therapy and perioperative period (within postoperative 30 days and 90 days) will be evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Wuhan Union Hospital, China

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neoadjuvant Immunotherapy and Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC	NCT04943029	Non Small Cell ...	Carrelizumab Pemetrexed (Non... Carboplatin Surgery	18 Years - 70 Years	Wuhan Union Hospital, China
Neoadjuvant Immunotherapy and Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC	NCT04943029	Non Small Cell ...	Carrelizumab Pemetrexed (Non... Carboplatin Surgery	18 Years - 70 Years	Wuhan Union Hospital, China
Neoadjuvant Immunotherapy and Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC	NCT04943029	Non Small Cell ...	Carrelizumab Pemetrexed (Non... Carboplatin Surgery	18 Years - 70 Years	Wuhan Union Hospital, China

Spots Global Cancer Trial Database for stage ⅲ nsclc