Non Small Cell Lung Cancer RecurrentPhase 2NCT05842018
Toripalimab in Combination With Chemotherapy and Antiangiogenic Agents in Patients With Non-Small Cell Lung Cancer After Failure of Immunotherapy (PD-1/L1 Inhibitors)
A Phase 2 study testing Toripalimab, Anlotinib and Chemotherapy in people with Non Small Cell Lung Cancer Recurrent, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
This is a phase II, single arm, open-label, single-center study to evaluate the efficacy and safety of Toripalimab combined with Chemotherapy and Antiangiogenic Agents in patients with Non-Small Cell Lung Cancer After Failure of Immunotherapy (PD-1/L1 inhibitors) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Small Cell Lung Cancer Recurrent
- What is being tested?
- Toripalimab, Anlotinib and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 1 Nov 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients voluntarily participate in this study, signed and dated informed consent with good compliance and follow-up;
- Diagnosed as locally advanced and / or metastatic non-small cell lung adenocarcinoma (NSCLC) by cytology or histology;
- First-line PD-1/PD-L1 inhibitors treatment failure;
- Provide detectable specimens (tissue or blood) for genotyping before enrollment, and the patients should be with negative EGFR and ALK gene test results;
- Had at least one measurable lesion according to RECIST 1.1 criteria
- Anticipated overall survival more than 3 months;
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- ECOG (Eastern Cooperative Oncology Group) scale 0-2;
- Normal organ function and bone marrow function;
- Resistant to first-line immune checkpoint inhibitor therapy and discontinued for more than 4 weeks;
- Women of childbearing age must have taken reliable contraceptive measures and performed a pregnancy test (serum or urine) within 7 days prior to enrollment, and the results were negative, and were willing to use appropriate methods during the trial and 4 weeks after the last administration of the test drug.
Who cannot join
- Patients with small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer) ;
- Patients who have previously permanently discontinued immunotherapy due to immune-related serious adverse reactions;
- Patients who previously treated with antiangiogenic agents;
- A history of other malignancies within 5 years prior to inclusion, except for cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer treated with radical surgery, and ductal carcinoma in situ treated with radical surgery;
- Active, known or suspected autoimmune disease;
- Active or chronic hepatitis C or/and hepatitis B infection;
- History of interstitial lung disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Toripalimab in Combination With Chemotherapy and Antiangiogenic Agents in Patients With Non Small Cell Lung Cancer After Failure of Immunotherapy (PD-1/L1 Inhibitors): a Prospective, Single-arm, Phase II Trial
This is a phase II, single arm, open-label, single-center study to evaluate the efficacy and safety of Toripalimab combined with Chemotherapy and Antiangiogenic Agents in patients with Non-Small Cell Lung Cancer After Failure of Immunotherapy (PD-1/L1 inhibitors)
- Conditions
- Non Small Cell Lung Cancer Recurrent
- Being tested
- Toripalimab, Anlotinib and Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toripalimab, Anlotinib and ChemotherapyDrug
Also called JS001
Combination therapy:
Toripalimab 240mg will be intravenously administered on Day 1, Q3W; anlotinib: 12 mg qd d1-d14, d15-d21 discontinued, Q3W; investigator selected chemotherapy regimen (paclitaxel, pemetrexed or gemcitabine and other chemotherapeutic drugs which were not administered in the first-line therapy) for a total of 4 cycles.
Maintenance therapy:
After combination therapy, Patients who achieved complete response（CR）, partial response (PR), or stable disease (SD) were administered with toripalimab plus anlotinib as maintenance therapy. until disease progression or intolerable toxicity, treatment for 2 years, investigator decision, withdrawal of consent, or death.
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab, Chemotherapy and Antiangiogenic Agents | Experimental | Not described Receives: Drug: Toripalimab, Anlotinib and Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress free survival
Progress free survival is defined as the time from first dose of study treatment until the first date of either disease progression or death due to any cause.
Measured: until Progressive Disease (PD) or death (up to 24 months)
Secondary outcomes (3)
Objective Response Rate
Objective response rate is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.
Measured: each 21 days up to intolerance the toxicity or PD (up to 24 months)
Overall Survival
Overall survival is defined as the time until death due to any cause.
Measured: from first dose of study treatment until death (up to 24 months)
Disease Control Rate
Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
Measured: each 21 days up to intolerance the toxicity or PD (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 May 2023 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Nov 2025 (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 Cancer RecurrentStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842018
- Sponsor's protocol ID
- JS001-NSCLC-CO396
- Status last verified
- Mar 2023
- First submitted
- 24 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toripalimab in Combination With Chemotherapy and Antiangiogenic Agents in Patients With Non Small Cell Lung Cancer After Failure of Immunotherapy (PD-1/L1 Inhibitors): a Prospective, Single-arm, Phase II Trial
- ClinicalTrials.gov ID
- NCT05842018
- Acronym / sponsor ID
- JS001-NSCLC-CO396
- Conditions
- Non Small Cell Lung Cancer Recurrent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 3 May 2023 (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 phase II, single arm, open-label, single-center study to evaluate the efficacy and safety of Toripalimab combined with Chemotherapy and Antiangiogenic Agents in patients with Non-Small Cell Lung Cancer After Failure of Immunotherapy (PD-1/L1 inhibitors)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toripalimab, Chemotherapy and Antiangiogenic Agents | Experimental | Drug: Toripalimab, Anlotinib and Chemotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients voluntarily participate in this study, signed and dated informed consent with good compliance and follow-up;
- Diagnosed as locally advanced and / or metastatic non-small cell lung adenocarcinoma (NSCLC) by cytology or histology;
- First-line PD-1/PD-L1 inhibitors treatment failure;
- Provide detectable specimens (tissue or blood) for genotyping before enrollment, and the patients should be with negative EGFR and ALK gene test results;
- Had at least one measurable lesion according to RECIST 1.1 criteria
Key exclusion criteria (7 listed)
- Patients with small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer) ;
- Patients who have previously permanently discontinued immunotherapy due to immune-related serious adverse reactions;
- Patients who previously treated with antiangiogenic agents;
- A history of other malignancies within 5 years prior to inclusion, except for cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer treated with radical surgery, and ductal carcinoma in situ treated with radical surgery;
- Active, known or suspected autoimmune 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 |
|---|---|---|
| Toripalimab, Anlotinib and ChemotherapyAlso: JS001Combination therapy: Toripalimab 240mg will be intravenously administered on Day 1, Q3W; anlotinib: 12 mg qd d1-d14, d15-d21 discontinued, Q3W; investigator selected chemotherapy regimen (paclitaxel, pemetrexed or gemcitabine and other chemotherapeutic drugs which were not administered in the first-line therapy) for a total of 4 cycles. Maintenance therapy: After combination therapy, Patients who achieved complete response（CR）, partial response (PR), or stable disease (SD) were administered with toripalimab plus anlotinib as maintenance therapy. until disease progression or intolerable toxicity, treatment for 2 years, investigator decision, withdrawal of consent, or death. | Drug | Toripalimab, Chemotherapy and Antiangiogenic Agents |
Primary outcome
Progress free survival
Time frame: until Progressive Disease (PD) or death (up to 24 months)
Progress free survival is defined as the time from first dose of study treatment until the first date of either disease progression or death due to any cause.
3 secondary outcomes
Objective Response Rate
Time frame: each 21 days up to intolerance the toxicity or PD (up to 24 months)
Overall Survival
Time frame: from first dose of study treatment until death (up to 24 months)
Disease Control Rate
Time frame: each 21 days up to intolerance the toxicity or PD (up to 24 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Toripalimab, Anlotinib and Chemotherapy in people with Non Small Cell Lung Cancer Recurrent, run by Tianjin Medical University Cancer Institute and Hospital.
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 10 inclusion and 7 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 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongying Liu (+86 022 23340123 ext. 1157, ldytjnk@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress free survival (time frame: until Progressive Disease (PD) or death (up to 24 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 3 May 2023.