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Lung Cancer Squamous CellPhase 3NCT03668496

A Study of SHR-1210 in Combination With Carboplatin + Paclitaxel in Subjects With Squamous NSCLC

A Phase 3 study testing SHR-1210 in people with Lung Cancer Squamous Cell and Lung Cancer Stage IV, run by Jiangsu HengRui Medicine Co., Ltd. at 53 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a randomized, placebo-controlled, double-blind, multicenter phase III clinical study. Target population is patients with stage IV squamous non-small cell lung cancer who had not received systemic chemotherapy. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
SHR-1210
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
390 participants
Where
53 sitesChina
Study dates
9 Nov 2018to 31 Dec 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects with histopathological diagnosis of squamous non-small cell lung cancer (SqNSCLC) 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
  • Has archived Tumor tissue samples
  • Subject must have a measurable target lesion based on RECIST v1.1 .
  • Has adequate organ function.
  • Women of childbearing age must undergo a serological pregnancy test within 7 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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 paclitaxel or their preventive drugs;

Trial locations and contacts

53 sites in 1 country.

53 sites in 1 country

China53 sites

  • Baoji Central Hospital

    Baoji, Shanxi, 721000

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100000

  • The Fifth Medical Center of PLA Ceneral Hospital

    Beijing, Beijing Municipality, 100000

  • The Seventh Medical Center of PLA Ceneral Hospital

    Beijing, Beijing Municipality, 100000

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin, 130012

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130012

  • Hunan Cancer Hospital

    Changsha, Hunan, 410006

  • The Second Xiangya Hospital Of Central South University

    Changsha, Hunan, 410008

  • The Third Xiangya Hospital Of Central South University

    Changsha, Hunan, 410013

  • Heping Hospital Affiliated to Changzhi Medical College

    Changzhi, Shanxi, 046000

  • Affiliated Hospital of Chengde Medical College

    Chengde, Hebei, 067000

  • Sichuan Provincial Cancer Hospital

    Chengdu, Sichuan, 610000

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

  • 900TH Hospital of Joint Logistics Support Force

    Fuzhou, Fujian, 350001

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, Guangdong, 510095

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital，ZheJiang University

    Hangzhou, Zhejiang, 310003

  • Sir Run Run Shaw Hospital ZheJiang University School Of Medicine

    Hangzhou, Zhejiang, 310018

  • ZheJiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • The Second Affiliated Hospital of Zhejiang University of Medicine

    Hangzhou, Zhejiang, 310052

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • Anhui Provincial Hospital

    Hefei, Anhui, 230036

  • The Second Affiliated Hospital Of Anhui Medical University

    Hefei, Anhui, 230036

  • Anhui Chest Hospital

    Hefei, Anhui, MD

  • Jieyang People's Hospital

    Jieyang, Guangdong, 522000

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center

    Kunming, Yunnan, 650118

  • LinYi Cancer Hospital

    Linyi, Shandong, 276001

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 330006

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210000

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

  • Shanghai Changhai Hospital

    Shanghai, Shanghai Municipality, 200433

  • Shanghai Pulmonary Hospital, Tongji University

    Shanghai, Shanghai Municipality, 200433

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

  • The Fourth Hospital of Hebei Medical University (Hebei Cancer Hospital)

    Shijiazhuang, Hebei, 50000

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi, 030000

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, 317000

  • Tangshan People's Hospital

    Tangshan, Hebei, 63001

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430000

  • Tongji Hospital, Tongji Medical College of Hust

    Wuhan, Hubei, 430000

  • Affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu, 214122

  • Shaanxi Provincial Cancer Hospital

    Xian, Shanxi, 710061

  • Xiang yang Central Hospital

    Xiangyang, Hubei, 441000

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225001

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, 563003

Other trials in China

About this study

Official title: A Phase III, Randomized,Double-Blind, Multi-center Study to Investigate the Efficacy and Safety of SHR-1210 in Combination With Carboplatin and Paclitaxel Versus Placebo in Combination With Carboplatin and Paclitaxel in First-Line Stage IV Squamous Non-Small Cell Lung Cancer

This study is a randomized, placebo-controlled, double-blind, multicenter phase III clinical study. Target population is patients with stage IV squamous non-small cell lung cancer who had not received systemic chemotherapy. Study objective is to compare the efficacy and safety of SHR-1210 + carboplatin + paclitaxel with placebo + carboplatin + paclitaxel in study population in China. SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.

Read the detailed description

In this study, eligible subject will be randomized into study arm or control arm to accept study treatment. Subjects who randomized into control will have the opportunity to receive cross over treatment of SHR-1210 monotherapy after confirmed disease progression. Treatment cycles of chemotherapy will be 4-6 which will be decided by investigators.

Being tested
SHR-1210, The placebo
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-1210Drug

    Drug delivery cycle is 3 weeks, and in the experimental group,200 mg shr-1210 was given with Carboplatin and Paclitaxel in the first day of each cycle, with intravenous drip.

  • The placeboDrug

    in the control group,placebo was given with Carboplatin and Paclitaxel in the first day of each cycle, with intravenous drip.

Study groups in NCT03668496
Study groupRoleWhat they receive
SHR-1210 +chemotherapyExperimentalsubject will receive SHR-1210 200mg every 3 weeks, carboplatin AUC 5 on Day 1 of each 21 day, 4-6 cycles Paclitaxel 175mg/m2, Day 1 of each 21 day, 4-6 cycles
Receives: Drug: SHR-1210
chemotherapyActive comparatorcarboplatin AUC 5 on Day 1 of each 21 day, 4-6 cycles Paclitaxel 175mg/m2, Day 1 of each 21 day, 4-6 cycles
Receives: Drug: The placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the Independent Review Committee according to RECIST v1.1 or death from any cause, whichever occurs first.

    Measured: up to 24 month

Secondary outcomes (6)

  1. Progression-free survival

    Progression-free survival (PFS) assessed by investigators according to RECIST V 1.1

    Measured: up to 24 month

  2. Overall Survival (OS)

    defined as time from the randomized to the time of the patient's death from any reason assessed by researchers.

    Measured: up to 24 month

  3. Objective Response Rate (ORR)

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

    Measured: up to 24 month

  4. 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.

    Measured: up to 24 month

  5. Duration of response （DoR）

    According to Recist v 1.1 accessed by investigators

    Measured: up to 24 month

  6. Adverse events (AEs)

    All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 4.03

    Measured: up to 24 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2018
  2. Study start9 Nov 2018
  3. Primary completion6 Nov 2020
  4. Study completion31 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
390 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03668496
Sponsor's protocol ID
SHR-1210-III-307
Status last verified
Mar 2021
First submitted
11 Sep 2018
Last updated
15 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Jiang T, Chen J, Xu X, Cheng Y, Chen G, Pan Y, Fang Y, Wang Q, Huang Y, Yao W, Wang R, Li X, Zhang W, Zhang Y, Hu S, Guo R, Shi J, Wang Z, Cao P, Wang D, Fang J, Luo H, Geng Y, Xing C, Lv D, Zhang Y, Yu J, Cang S, Zhang Y, Zhang J, Yang Z, Shi W, Zou J, Zhou C, Ren S. On-treatment blood TMB as predictors for camrelizumab plus chemotherapy in advanced lung squamous cell carcinoma: biomarker analysis of a phase III trial. Mol Cancer. 2022 Jan 3;21(1):4. doi: 10.1186/s12943-021-01479-4.

    PubMed 34980131

  • Ren S, Chen J, Xu X, Jiang T, Cheng Y, Chen G, Pan Y, Fang Y, Wang Q, Huang Y, Yao W, Wang R, Li X, Zhang W, Zhang Y, Hu S, Guo R, Shi J, Wang Z, Cao P, Wang D, Fang J, Luo H, Geng Y, Xing C, Lv D, Zhang Y, Yu J, Cang S, Yang Z, Shi W, Zou J, Zhou C; CameL-sq Study Group. Camrelizumab Plus Carboplatin and Paclitaxel as First-Line Treatment for Advanced Squamous NSCLC (CameL-Sq): A Phase 3 Trial. J Thorac Oncol. 2022 Apr;17(4):544-557. doi: 10.1016/j.jtho.2021.11.018. Epub 2021 Dec 16.

    PubMed 34923163

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SHR-1210 in people with Lung Cancer Squamous Cell and Lung Cancer Stage IV, run by Jiangsu HengRui Medicine Co., Ltd. at 53 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: up to 24 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03668496, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021.

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