Camrelizumab With Chemotherapy in Adults With Medically Inoperable Early Stage NSCLC

A Pilot Study of Camrelizumab With Chemotherapy in Adults With Medically Inoperable Early Stage Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to assess the efficacy and safety of Camrelizumab plus chemotherapy in the treatment of adult participants with medically inoperable Stage I or IIA non-small cell lung cancer (NSCLC).

Study Overview

• Status: Recruiting
• Conditions: Early Stage Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Pemetrexed; Drug: Biological: Camrelizumab; Drug: Nab-paclitaxel

Detailed Description

This trial will evaluate the safety and efficacy of camrelizumab in combination with chemotherapy, followed by camrelizumab alone after 4-6 cycles of combination in participants with medically inoperable stage I or IIA non-small cell lung cancer (NSCLC). The primary objective of this pilot study is to determine the Camrelizumab plus chemotherapy improves progression-free survival (PFS) . All the efficacy and safety are assessed by investigator : 1) response rate (ORR), 2) disease control rate (DCR); 3) overall survival (OS), 4) PFS rate of 1-year, 2-year, and 5-year; and 5) OS rate of 1-year, 2-year, and 5-year.

Explore objective is potential biomarker associated with efficacy.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Changli Wang, PhD; Phone Number: 6417 86-22-23340123; Email: wangchangli@medmail.com.cn
• Study Contact Backup: Name: Lianming Zhang, PhD; Phone Number: 6417 86-22-23340123

Study Locations

• China
  • Tianjin, China, 300060
    • Recruiting
    • Tianjin Medical University Cancer Institute and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients aged ≥18 years, male and female are not limited;
2. Patients with ECOG score of 0-1;
3. Life expectancy ≥12 weeks;
4. Patients must have histologically- or cytologically-documented NSCLC (according to 2015 WHO Classification);
5. Patients with stage I - IIA (T1-T2bN0M0, tumor size ≤ 50mm) confirmed by radiographic；and medical inoperable, unable to undergo thoracic surgery, or refusing to surgery (according to the eighth edition of TNM staging);
6. Patients with measurable target lesions according to the RECIST 1.1 standard;
7. Patients have not received prior treatment for their NSCLC, including radiotherapy, chemotherapy, surgery and target drugs;
8. Can provide tumor tissue;
9. Adequate organ and marrow function;
10. Fertile female were required to have a serum or urine pregnancy test within 72 hours before the start dose of study medication and the result has been negative;If female of childbearing potential, is willing to use adequate contraception for the course of the study through 90 days after the last dose of study medication; if male with a female partner(s) of child-bearing potential, must agree to use adequate contraception starting with the first dose of study medication through 90 days after the last dose of study medication;
11. Provision of signed ICF.

Exclusion Criteria:

1. Known any distance metastases;
2. Patients with known EGFR gene mutation or ALK fusion mutation;
3. Patients with any active autoimmune disease or history of autoimmune disease;
4. Patients with innate or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C or co-infection with hepatitis B and hepatitis C;
5. Subjects requiring systemic treatment with corticosteroids (> 10 mg / day of prednisone or its equivalent) or other immunosuppressants within 14 days prior to the first administration;
6. Patient must not have received a live, attenuated vaccine within 4 weeks prior to the first administration;
7. Any therapy for NSCLC treatment;
8. Patients with other malignant tumors in the past 5 years;
9. Patients with previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiologic pneumonia, drug-induced pneumonia and active pneumonia confirmed by imaging;
10. Patients with cardiac insufficiency;
11. Routine urine test indicated that urine protein was >= (+ +), or 24-hour urine protein was >= 1g, or severe liver and kidney dysfunction;
12. Patients with severe infection or fever of unknown origin >38.5 ℃ within 4 weeks prior to the first administration;
13. Patients with known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
14. Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraceptive measures;
15. Known allergies, hypersensitivity, or intolerance to camrelizumab or its excipients or to pemetrexed or to nab-paclitaxel;
16. Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of patient safety or study results，or the patient is unlikely to comply with study procedures, restrictions, and requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Camrelizumab combined with chemotherapy; Participants receive camrelizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 18 cycles PLUS Investigator's choice of chemotherapy. Interventions: Biological: Camrelizumab	Drug: Pemetrexed; chemotherapy; Other Names: Pemetrexed Disodium; Drug: Biological: Camrelizumab; PD-1; Other Names: SHR-1210; Drug: Nab-paclitaxel; chemotherapy; Other Names: Paclitaxel for Injection（Albumin Bound）

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	PFS is determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).	up to approximately 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the first date of treatment to date of death from any causes.	up to approximately 5 years
Objective response rate (ORR)	ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 by investigator.	up to approximately 1 years
Disease Control Rate (DCR)	DCR is defined as the percentage of patients who have achieved complete response and partial response per RECIST 1.1 by investigator..	up to approximately 3 years
Adverse Events (AEs)	The number of participants experiencing an AE will be assessed.	up to 18 months
PFS at 12 months (PFS12)	PFS will be calculated using Kaplan-Meier product limit methods.	up to maximum 12 months
PFS at 24 months (PFS24)	PFS will be calculated using Kaplan-Meier product limit methods.	up to maximum 24 months
PFS at 5 years	PFS will be calculated using Kaplan-Meier product limit methods.	up to maximum 5 years
OS at 12 months (OS12)	OS will be calculated using Kaplan-Meier product limit methods.	up to maximum 12 months
OS at 24 months (OS24)	OS will be calculated using Kaplan-Meier product limit methods.	up to maximum 24 months
OS at 5 years	OS will be calculated using Kaplan-Meier product limit methods.	up to maximum 5 years

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2020
• Primary Completion (Anticipated): June 30, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: programmed cell death 1 (PD-1, PD1); programmed cell death-ligand 1 (PD-L1, PDL1)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Folic Acid Antagonists; Paclitaxel; Albumin-Bound Paclitaxel; Pemetrexed
• Other Study ID Numbers: MA-NSCLC-II-007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No