Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Carboplatin

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Subjects receive SHR-1210 200mg and pemetrexed 500 mg/m\^2 and carboplatin AUC 5, administered as IV infusion on Day 1 of each 21-day cycle for 4-6 cycles followed by optional SHR-1210 200mg and pemetrexed 500 mg/m\^2 every three weeks (Q3W) maintenance for the remainder of the study or until documented PD.

Subjects receive pemetrexed 500 mg/m\^2 and carboplatin Area Under the Curve (AUC) 5, administered as IV infusion on Day 1 of each 21-day cycle for 4-6 cycles followed by optional pemetrexed 500 mg/m\^2 every three weeks (Q3W) maintenance for the remainder of the study or until documented PD. If PD occurs, Subjects may be able to receive SHR-1210 Q3W for the remainder of the study or until documented PD.

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.

SHR-1210

Wei Shi, MD

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is a randomized,Phase III, multicenter ,open-label study designed to evaluate the safety and efficacy of SHR-1210 with carboplatin and pemetrexed versus carboplatin-pemetrexed in subjects who are chemotherapy naive and have Stage IIIB/IV non-squamous NSCLC.

The primary hypothesis is that SHR-1210 combined with carboplatin and pemetrexed prolongs Progression Free Survival (PFS) in per RECIST 1.1 by blinded independent central review (ITT population and population was indicated by high PD-L1 expression) compared to carboplatin and pemetrexed treatment .

In this study, subjects will be randomly assigned to receive either carboplatin and pemetrexed for 4-6 cycles followed by pemetrexed maintenance until progression or unacceptable toxicity, OR receive SHR-1210 combined with carboplatin and pemetrexed chemotherapy for 4-6 cycles followed by pemetrexed maintenance with SHR-1210 until progression or unacceptable toxicity (SHR-1210 for a maximum of 2 years).

Subjects assigned to the chemotherapy arm will have the opportunity to crossover to receive SHR-1210 monotherapy once they experience progression of disease (PD) defined by RECIST 1.1 and meet all the crossover criteria.

A Study of SHR-1210 in Combination With Pemetrexed and Carboplatin in Subjects With Non-squamous NSCLC

A Phase III, Randomized, Open-Label, Multi-center Study of SHR-1210(Anti-PD-1 Antibody) in Combination With Pemetrexed and Carboplatin as First Line Therapy in Subjects With Advanced/Metastatic Non-squamous Non-small Cell Lung Cancer

PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment.

Defined as the time from randomization to death from any cause.

Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.

Jiangsu HengRui Medicine Co., Ltd.

Subjects receive SHR-1210 intravenous at the dose 200mg on Day 1 every 2 weeks

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody

This is an open-label, single-arm, multi-center, phase 2 Study to evaluate SHR-1210(anti-PD-1 antibody) in in adult Chinese patients with advanced or metastatic non-small cell lung cancer who failed or progressed to prior first-line systemic treatment.

Enrolled subjects will be assigned to 4 cohorts on the basis of PD-L1 expression in tumor cells(\<1%, ≥1%-25%, ≥25%-50%, ≥50%) all will be treated with the standard SHR-1210 dose (200mg) , Q2W, until documented progressive disease (PD) occurs. Subjects will return to the clinic once every two weeks. Radiographic disease assessments will be performed every 6 weeks.

The primary study hypothesis is that treatment with SHR-1210 improves Objective Response Rate when compare with standard second-line therapy, no matter how much PD-L1 expression in tumor.

In similar clinical trials, anti-PD-1 and anti-PD-L1 antibodies produce durable responses in approximately 20% of unselected patients with advanced non-small-cell lung cancer. Developing reliable, validated biomarkers that identify patients with an increased probability of response to these antibodies remains a challenge.

Because the PD-1 pathway may be a key mechanism of immune escape in a subgroup of patients with non-small-cell lung cancer, PD-L1 expression in tumor or inflammatory cells is a candidate biomarker. However, PD-L1 expression has not been formally validated as a biomarker in contemporaneously collected tumor tissue.

Additionally the purpose of the study is to assess the correlation between the expression of PD-L1 in the tumor and the response to treatment with SHR-1210 in non-small cell lung cancer.

A Study to Evaluate SHR-1210 in Patients With Advanced or Metastatic NSCLC

An Open-label, Single-arm, Multi-center, Phase 2 Study to Evaluate SHR-1210(Anti-PD-1 Antibody) in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

Objective response is defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of SHR-1210 in Combination With Pemetrexed and Carboplatin in Subjects With Non-squamous NSCLC	NCT03134872	Lung Neoplasms Carcinoma, Non-... Respiratory Tra... Thoracic Neopla... Lung Diseases Respiratory Tra... Neoplasms by Si... Neoplasm, Bronc... Carcinoma, Bron...	SHR-1210 Carboplatin Pemetrexed	18 Years - 70 Years	Jiangsu HengRui Medicine Co., Ltd.
A Study to Evaluate SHR-1210 in Patients With Advanced or Metastatic NSCLC	NCT03085069	Lung Neoplasms Carcinoma, Non-... Respiratory Tra... Lung Disease Respiratory Tra... Neoplasm, Bronc... Carcinoma, Bron...	SHR-1210	18 Years - 80 Years	Jiangsu HengRui Medicine Co., Ltd.
A Study of SHR-1210 in Combination With Pemetrexed and Carboplatin in Subjects With Non-squamous NSCLC	NCT03134872	Lung Neoplasms Carcinoma, Non-... Respiratory Tra... Thoracic Neopla... Lung Diseases Respiratory Tra... Neoplasms by Si... Neoplasm, Bronc... Carcinoma, Bron...	SHR-1210 Carboplatin Pemetrexed	18 Years - 70 Years	Jiangsu HengRui Medicine Co., Ltd.
A Study to Evaluate SHR-1210 in Patients With Advanced or Metastatic NSCLC	NCT03085069	Lung Neoplasms Carcinoma, Non-... Respiratory Tra... Lung Disease Respiratory Tra... Neoplasm, Bronc... Carcinoma, Bron...	SHR-1210	18 Years - 80 Years	Jiangsu HengRui Medicine Co., Ltd.
A Study to Evaluate SHR-1210 in Patients With Advanced or Metastatic NSCLC	NCT03085069	Lung Neoplasms Carcinoma, Non-... Respiratory Tra... Lung Disease Respiratory Tra... Neoplasm, Bronc... Carcinoma, Bron...	SHR-1210	18 Years - 80 Years	Jiangsu HengRui Medicine Co., Ltd.

Spots Global Cancer Trial Database for neoplasm, bronchial