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Phase II Study of SHR-1210(Anti-PD-1 Antibody) Combination With Apatinib Versus Pemetrexed and Carboplatin in Subjects With KRAS Mutant Stage IV Non-squamous Non-small Cell Lung Cancer

Primary Purpose

NSCLC Stage IV, KRAS Gene Mutation, PD-1 Antibody

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

SHR-1210

Apatinib

Pemetrexed

Carboplatin

About this trial

This is an interventional treatment trial for NSCLC Stage IV

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects with histopathological diagnosis of adenocarcinoma non-small cell lung cancer (NSCLC) and clinical stage IV
has not received prior systemic treatment for metastatic NSCLC.
Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status
confirmes by the central laboratory as KRAS gene mutation
Has archived Tumor tissue samples
Subject must have a measurable target lesion based on RECIST v1.1 .
Women of childbearing age must undergo a serological pregnancy test within 3 days before the first dose with negative results. Female subjects of reproductive age and male subjects whose spouse is a woman of reproductive age must agree to effective contraception within 180 days after the study period and the last dose of the study drug.
Subjects should be voluntarily participate in clinical studies and informed consent should be signed.

Exclusion Criteria:

active brain metastases and meningeal metastasis
uncontrollable tumor-related pain
massive pleural effusion, peritoneal effusion or pericardial effusion which cannot be controlled by repeated drainage;
radiotherapy to lung that is >30 Gy within 24 weeks before the first dose,
imaging (CT or MRI) showed that the tumor invading the large vessels
Known EGFR/ALK mutation.
subjects with any known or suspected autoimmune diseases
subjects with known or suspected interstitial pneumonia;
Subjects with severe cardiovascular and cerebrovascular diseases
arteriovenous thrombosis events, such as deep vein thrombosis and pulmonary embolism, occurred within 3 months;
female subjects who are pregnant or lactation or who plan to be pregnant during the study period;
positive HIV test;
active hepatitis B
evidence of active TB infection within 1 year before first dose;
severe infection occurred within 4 weeks before the first dose
patients with clinically significant bleeding symptoms or with obvious bleeding tendency in the first month
subjects who is on systemic immunogenic agents;
a history of severe allergic reactions to other monoclonal antibodies/fusion proteins;
History of severe allergic reactions to carboplatin or pemetrexed or their preventive drugs;

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SHR-1210 +apatinib

chemotherapy

Arm Description

subject will receive SHR-1210 200mg every 2 weeks, apatinib 250mg every day

Pemetrexed 500mg/m2, Day 1 of each 21 day, 4 cycles carboplatin AUC 5 on Day 1 of each 21 day, 4 cycles followed by pemetrexed 500mg/m2 until progression Q3W

Outcomes

Primary Outcome Measures

Duration of Progression-Free Survival (PFS) as Assessed by the Independent Review Committee Using RECIST v1.1

PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the Independent Review Committee Using 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.

Secondary Outcome Measures

Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1

Time Frame: Baseline until PD or death, whichever occurs first

Duration of Overall Survival (OS)

Baseline until death from any cause

Objective Response Rate (ORR)

The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1.

disease control rate (DCR)

The proportion of patients who have achieved complete response， partial response and Stable disease assessed by investigators according to Recist v 1.1.

Duration of response （DoR）

Adverse events (AEs)

All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 5.0

Full Information

NCT ID

NCT03777124

First Posted

December 13, 2018

Last Updated

January 17, 2019

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Collaborators

Shanghai Chest Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03777124

Brief Title

Phase II Study of SHR-1210(Anti-PD-1 Antibody) Combination With Apatinib Versus Pemetrexed and Carboplatin in Subjects With KRAS Mutant Stage IV Non-squamous Non-small Cell Lung Cancer

Official Title

Phase II Study of SHR-1210(Anti-PD-1 Antibody) Combination With Apatinib Versus Pemetrexed and Carboplatin in Subjects With KRAS Mutant Stage IV Non-squamous Non-small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Unknown status

Study Start Date

February 2019 (Anticipated)

Primary Completion Date

April 2020 (Anticipated)

Study Completion Date

April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Collaborators

Shanghai Chest Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a randomized, open-label, multi-center, phase II trial to evaluate the efficacy and safety of SHR-1210 plus apatinib mesylate versus Pemetrexed and Carboplatin in Subjects with KRAS mutant stage IV non-squamous Non-small Cell Lung Cancer

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NSCLC Stage IV, KRAS Gene Mutation, PD-1 Antibody, Chemotherapy Effect

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SHR-1210 +apatinib

Arm Type

Experimental

Arm Description

subject will receive SHR-1210 200mg every 2 weeks, apatinib 250mg every day

Arm Title

chemotherapy

Arm Type

Active Comparator

Arm Description

Pemetrexed 500mg/m2, Day 1 of each 21 day, 4 cycles carboplatin AUC 5 on Day 1 of each 21 day, 4 cycles followed by pemetrexed 500mg/m2 until progression Q3W

Intervention Type

Drug

Intervention Name(s)

SHR-1210

Intervention Description

Subjects receive SHR-1210 intravenous every 2 weeks

Intervention Type

Drug

Intervention Name(s)

Apatinib

Intervention Description

Subjects receive Apatinib orally every day

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Intervention Description

Subjects receive Pemetrexed intravenous every 3 weeks

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

subjects receive carboplatin intravenous every 3 weeks

Primary Outcome Measure Information:

Title

Duration of Progression-Free Survival (PFS) as Assessed by the Independent Review Committee Using RECIST v1.1

Description

Time Frame

up to approximately 40 months

Secondary Outcome Measure Information:

Title

Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1

Description

Time Frame: Baseline until PD or death, whichever occurs first

Time Frame

up to approximately 40 months

Title

Duration of Overall Survival (OS)

Description

Baseline until death from any cause

Time Frame

up to approximately 40 months

Title

Objective Response Rate (ORR)

Description

The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1.

Time Frame

up to approximately 40 months

Title

disease control rate (DCR)

Description

The proportion of patients who have achieved complete response， partial response and Stable disease assessed by investigators according to Recist v 1.1.

Time Frame

up to approximately 40 months

Title

Duration of response （DoR）

Description

Duration of response （DoR）

Time Frame

up to approximately 40 months

Title

Adverse events (AEs)

Description

All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 5.0

Time Frame

up to approximately 40 months

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

KRAS mutant

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects with histopathological diagnosis of adenocarcinoma non-small cell lung cancer (NSCLC) and clinical stage IV has not received prior systemic treatment for metastatic NSCLC. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status confirmes by the central laboratory as KRAS gene mutation Has archived Tumor tissue samples Subject must have a measurable target lesion based on RECIST v1.1 . Women of childbearing age must undergo a serological pregnancy test within 3 days before the first dose with negative results. Female subjects of reproductive age and male subjects whose spouse is a woman of reproductive age must agree to effective contraception within 180 days after the study period and the last dose of the study drug. Subjects should be voluntarily participate in clinical studies and informed consent should be signed. Exclusion Criteria: active brain metastases and meningeal metastasis uncontrollable tumor-related pain massive pleural effusion, peritoneal effusion or pericardial effusion which cannot be controlled by repeated drainage; radiotherapy to lung that is >30 Gy within 24 weeks before the first dose, imaging (CT or MRI) showed that the tumor invading the large vessels Known EGFR/ALK mutation. subjects with any known or suspected autoimmune diseases subjects with known or suspected interstitial pneumonia; Subjects with severe cardiovascular and cerebrovascular diseases arteriovenous thrombosis events, such as deep vein thrombosis and pulmonary embolism, occurred within 3 months; female subjects who are pregnant or lactation or who plan to be pregnant during the study period; positive HIV test; active hepatitis B evidence of active TB infection within 1 year before first dose; severe infection occurred within 4 weeks before the first dose patients with clinically significant bleeding symptoms or with obvious bleeding tendency in the first month subjects who is on systemic immunogenic agents; a history of severe allergic reactions to other monoclonal antibodies/fusion proteins; History of severe allergic reactions to carboplatin or pemetrexed or their preventive drugs;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jianjun Zou, MD, PhD

Phone

021-60453139

zoujianjun@hrglobe.cn

First Name & Middle Initial & Last Name or Official Title & Degree

ChengLei qiao, PM

qiaochenglei@hrglobe.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianjun Zou, MD, PhD

Organizational Affiliation

Jiangsu HengRui Medicine Co., Ltd.

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Shun Lu, MD, PhD

Organizational Affiliation

Jiaotong University,Shanghai chest Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Phase II Study of SHR-1210(Anti-PD-1 Antibody) Combination With Apatinib Versus Pemetrexed and Carboplatin in Subjects With KRAS Mutant Stage IV Non-squamous Non-small Cell Lung Cancer

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