NSCLCPhase 2JS001NCT03513666
A Study of Toripalimab+ Pemetrexed Plus Carboplatin in Patients With EGFR-mutation Positive and T790M Negative After Progression on EGFR-TKI Treatment
A Phase 2 study testing Drug intervention in people with NSCLC, run by Shanghai Junshi Bioscience Co., Ltd. at 5 sites in China.
Trial summary
JS001 combined with pemetrexed plus carboplatin for treatment of recurrent or advanced non-small-cell lung cancer with EGFR-mutation positive and T790M negative after progression on EGFR-TKI treatment：a multi-center, single arm phase II study Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Drug intervention
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesChina
- Study dates
- 9 Apr 2018to 12 Aug 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Only the patients meeting all the following criteria can be eligible to participate in the trial:
- Histologically and/or cytologically confirmed advanced or recurrent non-small cell lung cancer with EGFR sensitive mutation (exon 19 deletion, exon 21 L858R), and meeting the following conditions at the same time:
- Previous first-line EGFR-TKI monotherapy with clinical benefit, followed by progression of disease;
- No exon 20 T790M mutation after failure of EGFR-TKI therapy;
- At least one measurable lesion (in accordance with RECIST 1.1);
Who cannot join
- Patients who fulfill any of the following criteria must be excluded from the study:
- Histologically or cytopathologically confirmed combined with small cell lung cancer component or squamous cell carcinoma component >10%;
- Combined with other driver gene mutation with known drug therapy, including but not limited to ALK rearrangement, ROS1 mutation, BRAF600E mutation etc.;
- Previous systemic chemotherapy for advanced NSCLC;
- EGFR-TKI therapy within two weeks prior to enrollment;
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang, 310003
Zhengjiang Cancer Hospital
Hangzhou, Zhengjiang, 310022
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Shanghai Pulmonary Hospita
Shanghai, Shanghai Municipality
Tangdu Hospital
Xi’an, Shanxi
About this study
Official title: Toripalimab Combined With Pemetrexed Plus Carboplatin for Treatment of Recurrent or Advanced Non-small-cell Lung Cancer With EGFR-mutation Positive and T790M Negative After Progression on EGFR-TKI Treatment：a Multi-center, Single Arm Phase II Study
JS001 combined with pemetrexed plus carboplatin for treatment of recurrent or advanced non-small-cell lung cancer with EGFR-mutation positive and T790M negative after progression on EGFR-TKI treatment：a multi-center, single arm phase II study
- Conditions
- NSCLC
- Being tested
- Drug intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug interventionCombination product
anti-PD-1 monoclonal antibody Toripalimab injection combined with Pemetrexed and carboplatin
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | Toripalimab 240 mg or 360 mg Q3W in combination with chemotherapy Receives: Combination Product: Drug intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The primary endpoint is the antitumor activities in this study
Measured: 12 weeks
Secondary outcomes (3)
PFS
Progression free survival (PFS)
Measured: 18 months
OS
Overall survival (OS)
Measured: 18 months
DOR
Duration of response (DOR)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start9 Apr 2018
- Primary completion12 Aug 2022
- Study completion12 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NSCLCStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513666
- Sponsor's protocol ID
- JS001-PII-LC-001
- Acronym
- JS001
- Status last verified
- Aug 2023
- First submitted
- 19 Apr 2018
- Last updated
- 23 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li LC, Chen XW, Fang L, Jian CL, Yu YX, Liao XY, Sun JG. YAP1 as a Novel Negative Biomarker of Immune Checkpoint Inhibitors for EGFR-Mutant Non-Small-Cell Lung Cancer. Can Respir J. 2023 Jun 21;2023:4689004. doi: 10.1155/2023/4689004. eCollection 2023.
PubMed 37388902
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toripalimab Combined With Pemetrexed Plus Carboplatin for Treatment of Recurrent or Advanced Non-small-cell Lung Cancer With EGFR-mutation Positive and T790M Negative After Progression on EGFR-TKI Treatment：a Multi-center, Single Arm Phase II Study
- ClinicalTrials.gov ID
- NCT03513666
- Acronym / sponsor ID
- JS001 / JS001-PII-LC-001
- Conditions
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 12 Aug 2022 (actual)
- Study completion
- 12 Aug 2022 (actual)
- First posted
- 1 May 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.
JS001 combined with pemetrexed plus carboplatin for treatment of recurrent or advanced non-small-cell lung cancer with EGFR-mutation positive and T790M negative after progression on EGFR-TKI treatment：a multi-center, single arm phase II study
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Combination Product: Drug interventionToripalimab 240 mg or 360 mg Q3W in combination with chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Only the patients meeting all the following criteria can be eligible to participate in the trial:
- Histologically and/or cytologically confirmed advanced or recurrent non-small cell lung cancer with EGFR sensitive mutation (exon 19 deletion, exon 21 L858R), and meeting the following conditions at the same time:
- Previous first-line EGFR-TKI monotherapy with clinical benefit, followed by progression of disease;
- No exon 20 T790M mutation after failure of EGFR-TKI therapy;
- At least one measurable lesion (in accordance with RECIST 1.1);
Key exclusion criteria (5 listed)
- Histologically or cytopathologically confirmed combined with small cell lung cancer component or squamous cell carcinoma component >10%;
- Combined with other driver gene mutation with known drug therapy, including but not limited to ALK rearrangement, ROS1 mutation, BRAF600E mutation etc.;
- Previous systemic chemotherapy for advanced NSCLC;
- EGFR-TKI therapy within two weeks prior to enrollment;
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 |
|---|---|---|
| Drug interventionanti-PD-1 monoclonal antibody Toripalimab injection combined with Pemetrexed and carboplatin | Combination product | treatment arm |
Primary outcome
Objective response rate (ORR)
Time frame: 12 weeks
The primary endpoint is the antitumor activities in this study
3 secondary outcomes
PFS
Time frame: 18 months
OS
Time frame: 18 months
DOR
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Derived from this study: PubMed 37388902Li LC, Chen XW, Fang L, Jian CL, Yu YX, Liao XY, Sun JG. YAP1 as a Novel Negative Biomarker of Immune Checkpoint Inhibitors for EGFR-Mutant Non-Small-Cell Lung Cancer. Can Respir J. 2023 Jun 21;2023:4689004. doi: 10.1155/2023/4689004. eCollection 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Drug intervention in people with NSCLC, run by Shanghai Junshi Bioscience Co., Ltd. at 5 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective response rate (ORR) (time frame: 12 weeks). 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 NCT03513666, which also lists 1 linked publication.
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 23 Aug 2023.