NCT04943029

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Carrelizumab	Camrelizumab: 200mg, IV, day 1 of each 21-day cycle, neoadjuvant therapy : 3 cycles; Adjuvant therapy: 16cycles.
DRUG	Pemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel(Squamous NSCLC)	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.
DRUG	Carboplatin	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.
PROCEDURE	Surgery	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)

Timeline

• Start date: 2021-08-20
• Primary completion: 2022-05-01
• Completion: 2024-08-01
• First posted: 2021-06-29
• Last updated: 2021-09-02

Locations

1 site across 1 country: China