A Two-arm (Phase 2) Exploratory Study of Nivolumab Monotherapy or in Combination With Nab-paclitaxel and Carboplatin in Early Stage NSCLC in China

Non Small Cell Lung Cancer Clinical Trial

Official title:

A Two-arm (Phase 2) Exploratory Study of Nivolumab Monotherapy or in Combination With Nab-paclitaxel and Carboplatin in Early Stage NSCLC in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04015778
• Other study ID #: CTONG 1804
• Status: Recruiting
• Phase: Phase 2
• Start date: August 8, 2019
• Est. completion date: July 2024

Study information

• Verified date: February 2020
• Source: Guangdong Association of Clinical Trials
• Contact: Yi-Long Wu
• Phone: +86 20 83827812
• Email: syylwu[@]live.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Nivolumab (BMS-936558) is a fully human, IgG4 (kappa) isotype mAb that binds PD-1 on activated immune cells and disrupts engagement of the receptor with its ligands PD-L1 (B7 H1/CD274) and PD-L2 (B7-DC/CD273), thereby abrogating inhibitory signals and augmenting the host antitumor response. In early clinical trials, nivolumab has demonstrated activity in several tumor types, including melanoma, renal cell carcinoma (RCC), and non-small cell lung cancer (NSCLC).

Nivolumab is in clinical development for the treatment of patients with NSCLC, RCC, melanoma, squamous cell carcinoma of the head and neck (SCCHN) and other tumors (eg, glioblastoma multiforme, mesothelioma, small cell lung cancer, gastric).

Nivolumab is approved in the United States (US), European Union, and other countries for the treatment of patients with unresectable or metastatic melanoma, advanced NSCLC with progression on or after platinum-based chemotherapy, advanced RCC whose disease progressed on an antiangiogenic therapy, classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin treatment, and recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy.

The proposed study will evaluate the efficacy and safety of preoperative administration of Nivolumab or Nivolumab combined with nab-paclitaxel and carboplatin in neoadjuvant setting and administration of Nivolumab in adjuvant setting in patients with high-risk resectable NSCLC, and will facilitate a comprehensive exploratory characterization of the tumor immune microenvironment and circulating immune cells in these patients. Data obtained in this study will provide valuable information for planning further prospective clinical trials of anti-PD-1 and other immunotherapies in NSCLC, both in the peri-operative and advanced disease setting. Ultimately, it is highly desirable to discover prospective biomarkers of response and toxicity to allow patients with NSCLC who are most likely to derive benefit to receive anti-PD-1 treatment, and conversely to minimize the risk of toxicity and ineffective treatment for patients who are unlikely to benefit.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: July 2024
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue

• Lung function capacity capable of tolerating the proposed lung surgery

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

• Available tissue of primary lung tumor

Exclusion Criteria:

• Presence of locally advanced, inoperable or metastatic disease

• Participants with active, known or suspected autoimmune disease

• Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)

Other protocol defined inclusion/exclusion criteria could apply

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Biological:
• Nivolumab
240mg Q2W or 360mg Q3W

Drug:
• carboplatin
AUC 5, d1 every three weeks
• nab-paclitaxel
135 mg/m2, d1, 8

Locations

Country	Name	City	State
China	Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Guangdong Association of Clinical Trials	Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MPR rate	MPR rate, defined as number participants with <10% residual tumor in lung and lymph nodes, divided by the number of treated participants for each arm Viable tumors in situ carcinoma should not be included in MPR calculation.	The patients considered to be technically resectable will undergo resection,an expected average of 13 weeks
Secondary	MPR rate in 2 subgroups patients (PD-L1 <1%, and 1-49%) in Arm B		The patients considered to be technically resectable will undergo resection,an expected average of 13 weeks
Secondary	Proportion of resection without delay		The patients considered to be technically resectable will undergo resection,an expected average of 13 weeks
Secondary	Number of Participants with Adverse Events	Safety and tolerability will be measured by incidence of AE, SAE, immune related AEs, deaths, and laboratory abnormalities	During the neoadjuvant period and 100 days post adjuvant period