Camrelizumab With Chemotherapy in Adults With Medically Inoperable Early Stage NSCLC

NCT04530227 | Unknown Phase 2

• 1 other identifier: MA-NSCLC-II-007
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Early Stage Non-small Cell Lung Cancer

Keywords

programmed cell death 1 (PD-1, PD1); programmed cell death-ligand 1 (PD-L1, PDL1)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Overall Survival (OS)

  up to approximately 5 years

• Objective response rate (ORR)

  up to approximately 1 years

• Disease Control Rate (DCR)

  up to approximately 3 years

• Adverse Events (AEs)

  up to 18 months

• PFS at 12 months (PFS12)

  up to maximum 12 months

Study Arms (1)

Camrelizumab combined with chemotherapy

EXPERIMENTAL

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: Biological: Camrelizumab; Drug: Pemetrexed; Drug: Nab-paclitaxel

Interventions

Biological: Camrelizumab DRUG

PD-1

Also known as: SHR-1210

Camrelizumab combined with chemotherapy

Pemetrexed DRUG

chemotherapy

Also known as: Pemetrexed Disodium

Camrelizumab combined with chemotherapy

Nab-paclitaxel DRUG

chemotherapy

Also known as: Paclitaxel for Injection（Albumin Bound）

Camrelizumab combined with chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥18 years, male and female are not limited;
• Patients with ECOG score of 0-1;
• Life expectancy ≥12 weeks;
• Patients must have histologically- or cytologically-documented NSCLC (according to 2015 WHO Classification);
• 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);
• Patients with measurable target lesions according to the RECIST 1.1 standard;
• Patients have not received prior treatment for their NSCLC, including radiotherapy, chemotherapy, surgery and target drugs;
• Can provide tumor tissue;
• Adequate organ and marrow function;
• 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;
• Provision of signed ICF.

You may not qualify if:

• Known any distance metastases;
• Patients with known EGFR gene mutation or ALK fusion mutation;
• Patients with any active autoimmune disease or history of autoimmune disease;
• 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;
• 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;
• Patient must not have received a live, attenuated vaccine within 4 weeks prior to the first administration;
• Any therapy for NSCLC treatment;
• Patients with other malignant tumors in the past 5 years;
• Patients with previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiologic pneumonia, drug-induced pneumonia and active pneumonia confirmed by imaging;
• Patients with cardiac insufficiency;
• Routine urine test indicated that urine protein was \>= (+ +), or 24-hour urine protein was \>= 1g, or severe liver and kidney dysfunction;
• Patients with severe infection or fever of unknown origin \>38.5 ℃ within 4 weeks prior to the first administration;
• Patients with known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraceptive measures;
• Known allergies, hypersensitivity, or intolerance to camrelizumab or its excipients or to pemetrexed or to nab-paclitaxel;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, 300060, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

camrelizumab; Pemetrexed; 130-nm albumin-bound paclitaxel; Paclitaxel

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Changli Wang, PhD

CONTACT

86-22-23340123; wangchangli@medmail.com.cn

Lianming Zhang, PhD

CONTACT

86-22-23340123

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 28, 2020
• Study Start: September 25, 2020
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: November 13, 2020

Record last verified: 2020-08

Locations

CN (1)