Non-Small-Cell Lung CancerPhase 3NCT04316364
A Trial of SHR-1316/Placebo in Combination With Chemotherapy in Patients With Resectable NSCLC
A Phase 3 study testing SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin and SHR-1316、Chemotherapeutic in people with Non-Small-Cell Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 7 sites in China.
Trial summary
This trial is designed to evaluate the efficacy, safety and immunogenicity of neoadjuvant treatment with monoclonal antibody SHR-1316 or placebo in combination with platinum doublet chemotherapy in participants with resectable Stage II, IIIA, or selected IIIB non-small cell lung cancer (NSCLC) followed by adjuvant… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-Small-Cell Lung Cancer
- What is being tested?
- SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin and SHR-1316、Chemotherapeutic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 537 participants
- Where
- 7 sitesChina
- Study dates
- 14 Jul 2020to 15 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Have previously untreated, pathologically confirmed resectable Stage II, IIIA, or Selected IIIB NSCLC. Staging should be based on the 8th edition of the AJCC/UICC staging system
- Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent
- Adequate tumor tissue sample blocks for central programmed death-ligand 1 (PD-L1) testing
- Measurable disease as defined by RECIST v1.1
- Adequate organ function
- Women of childbearing age without sterilizing or male, must agree to use contraception or practice abstinence at least 180 days after the last dose of study treatment
Who cannot join
- Any previous systematic anti-cancer therapy for lung cancer
- With active, known or suspected autoimmune disease of autoimmune disease
- Malignancies other than NSCLC within 5 years prior to randomization
- Has or suspected has a history of pneumonitis /interstitial lung disease or any serve lung diseases which will influence the examination of lung function
- Significant history of cardiovascular and cerebrovascular disease
- Significant haemorrhagic disease
Show all 14Show fewer
- Has an arteriovenous thrombotic events
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a known active Hepatitis B or Hepatitis C
- Allergic to monoclonal antibodies or other protein drugs
- Allergic to the intervention regimens
- Pregnant or lactating women
- Has known psychiatric or substance abuse disorders
- Confirmed COVID-19 infection or suspected COVID-19 infection or close contact with a person with known or suspected COVID-19 infection.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100000
Chen Keneng
- Recruiting
West China Hospital,Sichuan University
Chengdu, Sichuan, 610041
Lunxu Liu
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510000
Wenzhao Zhong
- Recruiting
ZheJiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Qixun Chen
- Recruiting
JiangSu Cancer Hospital
Nanjing, Jiangsu, 210009
Qin Zhang
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Di Ge
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Wenqun Xing
About this study
Official title: A Randomized, Double-Blind, Multicenter, Phase Ib/III Clinical Study on PD-L1 Monoclonal Antibody SHR-1316 or Placebo in Combination With Chemotherapy as Perioperative Treatment of Resectable Stage II or III Non-Small Cell Lung Cancer
This trial is designed to evaluate the efficacy, safety and immunogenicity of neoadjuvant treatment with monoclonal antibody SHR-1316 or placebo in combination with platinum doublet chemotherapy in participants with resectable Stage II, IIIA, or selected IIIB non-small cell lung cancer (NSCLC) followed by adjuvant SHR-1316 or placebo and monitoring.
- Conditions
- Non-Small-Cell Lung Cancer
- Being tested
- SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin, SHR-1316、Chemotherapeutic, Placebo、Chemotherapeutic
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1316、Paclitaxel (Albumin Bound)、CarboplatinDrug
Drug: SHR-1316, an engineered anti-PD-L1 antibody will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle Drug: Paclitaxel (Albumin Bound) will be administered intravenously on Day 1,8,15 of each 21-day cycle Drug: Carboplatin will be administered intravenously on Day 1 of each 21-day cycle
SHR-1316、ChemotherapeuticDrug
Drug: SHR-1316, an engineered anti-PD-L1 antibody will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle Drug: Chemotherapeutic drugs will be administered on Day 1 of each 21day cycle, if applicable, they will also be administered on Day 8 and/or Day 15 according to the drug package insert
Placebo、ChemotherapeuticDrug
Drug: Placebo, will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle Drug: Chemotherapeutic drugs will be administered on Day 1 of each 21day cycle, if applicable, they will also be administered on Day 8 and/or Day 15 according to the drug package insert
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Neoadjuvant setting: Drug: SHR-1316 and carboplatin and Paclitaxel (Albumin Bound) 3 cycles; Adjuvant setting: Drug: SHR-1316 up to 16 cycles Receives: Drug: SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin |
| Treatment group B | Experimental | Neoadjuvant setting: Drug: SHR-1316 and platinum-based dual chemotherapy 3 cycles; Adjuvant setting: Drug: SHR-1316 up to 16 cycles Receives: Drug: SHR-1316、Chemotherapeutic |
| Treatment group C | Placebo comparator | Neoadjuvant setting: Drug: Placebo and platinum-based dual chemotherapy 3 cycles; Adjuvant setting: Drug: Placebo up to 16 cycles Receives: Drug: Placebo、Chemotherapeutic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological response rate (MPR)
Measured: At time of surgery
Event free survival (EFS)
Measured: Approximately 66 months
Secondary outcomes (4)
Overall survival (OS)
Measured: Approximately 96 months
Pathology complete response (pCR)
Measured: At time of surgery
Objective response rate (ORR)
Measured: prior to surgery
Disease-Free Survival (DFS)
Measured: Approximately 66 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start14 Jul 2020
- Primary completion15 Apr 2023 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 537 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- YILONG WU, M.D, PhD, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316364
- Sponsor's protocol ID
- SHR-1316-III-303
- Status last verified
- Oct 2021
- First submitted
- 19 Mar 2020
- Last updated
- 4 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multicenter, Phase Ib/III Clinical Study on PD-L1 Monoclonal Antibody SHR-1316 or Placebo in Combination With Chemotherapy as Perioperative Treatment of Resectable Stage II or III Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04316364
- Acronym / sponsor ID
- SHR-1316-III-303
- Conditions
- Non-Small-Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 537 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 15 Apr 2023 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 20 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is designed to evaluate the efficacy, safety and immunogenicity of neoadjuvant treatment with monoclonal antibody SHR-1316 or placebo in combination with platinum doublet chemotherapy in participants with resectable Stage II, IIIA, or selected IIIB non-small cell lung cancer (NSCLC) followed by adjuvant SHR-1316 or placebo and monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR-1316、Paclitaxel (Albumin Bound)、CarboplatinNeoadjuvant setting: Drug: SHR-1316 and carboplatin and Paclitaxel (Albumin Bound) 3 cycles; Adjuvant setting: Drug: SHR-1316 up to 16 cycles |
| Treatment group B | Experimental | Drug: SHR-1316、ChemotherapeuticNeoadjuvant setting: Drug: SHR-1316 and platinum-based dual chemotherapy 3 cycles; Adjuvant setting: Drug: SHR-1316 up to 16 cycles |
| Treatment group C | Placebo comparator | Drug: Placebo、ChemotherapeuticNeoadjuvant setting: Drug: Placebo and platinum-based dual chemotherapy 3 cycles; Adjuvant setting: Drug: Placebo up to 16 cycles |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Have previously untreated, pathologically confirmed resectable Stage II, IIIA, or Selected IIIB NSCLC. Staging should be based on the 8th edition of the AJCC/UICC staging system
- Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent
- Adequate tumor tissue sample blocks for central programmed death-ligand 1 (PD-L1) testing
- Measurable disease as defined by RECIST v1.1
Key exclusion criteria (14 listed)
- Any previous systematic anti-cancer therapy for lung cancer
- With active, known or suspected autoimmune disease of autoimmune disease
- Malignancies other than NSCLC within 5 years prior to randomization
- Has or suspected has a history of pneumonitis /interstitial lung disease or any serve lung diseases which will influence the examination of lung function
- Significant history of cardiovascular and cerebrovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-1316、Paclitaxel (Albumin Bound)、CarboplatinDrug: SHR-1316, an engineered anti-PD-L1 antibody will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle Drug: Paclitaxel (Albumin Bound) will be administered intravenously on Day 1,8,15 of each 21-day cycle Drug: Carboplatin will be administered intravenously on Day 1 of each 21-day cycle | Drug | Treatment group A |
| SHR-1316、ChemotherapeuticDrug: SHR-1316, an engineered anti-PD-L1 antibody will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle Drug: Chemotherapeutic drugs will be administered on Day 1 of each 21day cycle, if applicable, they will also be administered on Day 8 and/or Day 15 according to the drug package insert | Drug | Treatment group B |
| Placebo、ChemotherapeuticDrug: Placebo, will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle Drug: Chemotherapeutic drugs will be administered on Day 1 of each 21day cycle, if applicable, they will also be administered on Day 8 and/or Day 15 according to the drug package insert | Drug | Treatment group C |
Primary outcome
Major pathological response rate (MPR)
Time frame: At time of surgery
Event free survival (EFS)
Time frame: Approximately 66 months
4 secondary outcomes
Overall survival (OS)
Time frame: Approximately 96 months
Pathology complete response (pCR)
Time frame: At time of surgery
Objective response rate (ORR)
Time frame: prior to surgery
Disease-Free Survival (DFS)
Time frame: Approximately 66 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
YILONG WU, M.D, PhD principal investigator
Guangdong Provincial People's Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin and SHR-1316、Chemotherapeutic in people with Non-Small-Cell Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 7 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 7 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vivian Shi, MD (+86 010-67166319, wei.shi@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathological response rate (MPR) (time frame: At time of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2021.