NSCLC Stage IVPhase 2NCT03777124
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
A Phase 2 study testing SHR-1210, Apatinib and Pemetrexed in people with NSCLC Stage IV and KRAS Gene Mutation, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- NSCLC Stage IV, KRAS Gene Mutation, PD-1 Antibody
- What is being tested?
- SHR-1210, Apatinib and Pemetrexed
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2019to 29 Jun 2023
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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.
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- 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;
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- NSCLC Stage IV, KRAS Gene Mutation, PD-1 Antibody, Chemotherapy Effect
- Being tested
- SHR-1210, Apatinib, Pemetrexed, Carboplatin
- 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-1210Drug
Subjects receive SHR-1210 intravenous every 2 weeks
ApatinibDrug
Subjects receive Apatinib orally every day
PemetrexedDrug
Subjects receive Pemetrexed intravenous every 3 weeks
CarboplatinDrug
subjects receive carboplatin intravenous every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| SHR-1210 +apatinib | Experimental | subject will receive SHR-1210 200mg every 2 weeks, apatinib 250mg every day Receives: Drug: SHR-1210; Drug: Apatinib |
| chemotherapy | Active comparator | 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 Receives: Drug: Pemetrexed; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to approximately 40 months
Secondary outcomes (6)
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
Measured: up to approximately 40 months
Duration of Overall Survival (OS)
Baseline until death from any cause
Measured: up to approximately 40 months
Objective Response Rate (ORR)
The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1.
Measured: up to approximately 40 months
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 approximately 40 months
Duration of response （DoR）
Duration of response （DoR）
Measured: up to approximately 40 months
Adverse events (AEs)
All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 5.0
Measured: up to approximately 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start11 Jul 2019
- Primary completion29 Jun 2023
- Study completion29 Jun 2023
Why it stopped: The sponsor's R\&D strategy is adjusted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IVStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Chest Hospital
- Responsible party
- Sponsor
- Investigators
- Jianjun Zou, MD, PhD, Study director, Jiangsu HengRui Medicine Co., Ltd.Shun Lu, MD, PhD, Principal investigator, Jiaotong University,Shanghai chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777124
- Sponsor's protocol ID
- SHR-1210-II-214
- Status last verified
- Jul 2025
- First submitted
- 13 Dec 2018
- Last updated
- 4 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03777124
- Acronym / sponsor ID
- SHR-1210-II-214
- Conditions
- NSCLC Stage IV, KRAS Gene Mutation, PD-1 Antibody, Chemotherapy Effect
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor's R\&D strategy is adjusted.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Chest Hospital
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 17 Dec 2018 (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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-1210 +apatinib | Experimental | Drug: SHR-1210, Drug: Apatinibsubject will receive SHR-1210 200mg every 2 weeks, apatinib 250mg every day |
| chemotherapy | Active comparator | Drug: Pemetrexed, Drug: CarboplatinPemetrexed 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (19 listed)
- 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
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-1210Subjects receive SHR-1210 intravenous every 2 weeks | Drug | SHR-1210 +apatinib |
| ApatinibSubjects receive Apatinib orally every day | Drug | SHR-1210 +apatinib |
| PemetrexedSubjects receive Pemetrexed intravenous every 3 weeks | Drug | chemotherapy |
| Carboplatinsubjects receive carboplatin intravenous every 3 weeks | Drug | chemotherapy |
Primary outcome
Duration of Progression-Free Survival (PFS) as Assessed by the Independent Review Committee Using RECIST v1.1
Time frame: up to approximately 40 months
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.
6 secondary outcomes
Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1
Time frame: up to approximately 40 months
Duration of Overall Survival (OS)
Time frame: up to approximately 40 months
Objective Response Rate (ORR)
Time frame: up to approximately 40 months
disease control rate (DCR)
Time frame: up to approximately 40 months
Duration of response （DoR）
Time frame: up to approximately 40 months
Adverse events (AEs)
Time frame: up to approximately 40 months
Results and safety
The study was stopped early (reason given: The sponsor's R\&D strategy is adjusted.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Jianjun Zou, MD, PhD study director
Jiangsu HengRui Medicine Co., Ltd.
Shun Lu, MD, PhD principal investigator
Jiaotong University,Shanghai chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-1210, Apatinib and Pemetrexed in people with NSCLC Stage IV and KRAS Gene Mutation, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site 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: stopped early, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The sponsor's R\&D strategy is adjusted.). 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?
Duration of Progression-Free Survival (PFS) as Assessed by the Independent Review Committee Using RECIST v1.1 (time frame: up to approximately 40 months). 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 Jul 2025.