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

NCT ID: NCT04943029

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-20
• Study Completion Date: 2024-08-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PD-1+Chemo+surgery+PD-1

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

Group Type: EXPERIMENTAL

Carrelizumab

Intervention Type: DRUG

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

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

Intervention Type: DRUG

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.

Carboplatin

Intervention Type: DRUG

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

Intervention Type: PROCEDURE

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)

Interventions

Carrelizumab

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

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)

Intervention Type: PROCEDURE

Other Intervention Names

PD-1 antibody; chemotherapeutic drug

Eligibility Criteria

Inclusion Criteria

• Written informed consent provided.
• Age 18-70 when signing the consent form, both male and female;
• The ECOG score is 0 or 1;
• Unresectable stage III non-small cell lung cancer confirmed by histopathology or cytology（III A-bulky N2, III B，IIIC）;
• Adequate hematological function, liver function and renal function;
• Female participants should not be pregnant or breast-feeding.

Exclusion Criteria

• EGFR mutation or ALK mutation was positive;
• Previously received systemic anti-tumor therapy for non-small cell lung cancer;
• Subjects who have received chest radiotherapy in the past;
• Known human immunodeficiency virus (HIV) infection;
• Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease);
• Pregnancy or breast-feeding women;
• Ingredients mixed with small cell lung cancer patients.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yongde Liao, PhD

Role: PRINCIPAL_INVESTIGATOR

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Locations

Wuhan Union Hospital

Wuhan, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongde Liao, PhD

Role: CONTACT

liaotjxw@126.com

+86 15972212919

Mingliang Wang, MD

Role: CONTACT

wml6667@126.com

+86 15927066167

Facility Contacts

Mingliang Wang, MD

Role: primary

wml6667@163.com

+86 15927066167

Other Identifiers

NEOSUN

Identifier Type: -

Identifier Source: org_study_id